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Use of Music Listening to Enhance Acute Surgical Pain Management with Patients Undergoing Orthopedic Surgery

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Title:
Use of Music Listening to Enhance Acute Surgical Pain Management with Patients Undergoing Orthopedic Surgery
Creator:
Laframboise-Otto, Joanne Margaret
Place of Publication:
[Gainesville, Fla.]
Florida
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University of Florida
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english
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1 online resource (178 p.)

Thesis/Dissertation Information

Degree:
Doctorate ( Ph.D.)
Degree Grantor:
University of Florida
Degree Disciplines:
Nursing Sciences
Nursing
Committee Chair:
HORGAS,ANN L
Committee Co-Chair:
YOON,SAUN-JOO
Committee Members:
GARVAN,CYNTHIA S
CAMPBELL,DALE FRANKLIN

Subjects

Subjects / Keywords:
management -- pain
Nursing -- Dissertations, Academic -- UF
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bibliography ( marcgt )
theses ( marcgt )
government publication (state, provincial, terriorial, dependent) ( marcgt )
born-digital ( sobekcm )
Electronic Thesis or Dissertation
Nursing Sciences thesis, Ph.D.

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Abstract:
In the hospital setting, nurses have the major responsibility of pain management and comfort care with patients undergoing surgery. Further, patients commonly look to nurses for help in relieving pain and achieving comfort. If not adequately managed, uncontrolled pain not only causes needless suffering, but can contribute to cardiovascular, respiratory, gastrointestinal, genitourinary, and neuroendocrine problems after surgery When implementing best practice, nurses need to determine if pain management strategies like music therapy can support the strengths and meet the needs of surgical patients, with the intentions of relieving physical pain, achieving psychological comfort, and promoting recovery from surgery. The purpose of this study is to investigate the use of a music intervention as an adjuvant with prescribed analgesics to help reduce acute surgical pain, analgesic usage, and analgesic side effects with patients undergoing orthopedic surgery. Further, the study will examine how the effective use of postoperative analgesics and music listening can balance analgesia (pain relief) and analgesic side effects with postoperative orthopedic surgery patients. A convenience sample of 50 patients who are undergoing either hip or knee joint replacement surgery at UF Health in Gainesville, FL will comprise the study sample. Using an experimental design, twenty-five participants randomly assigned to the treatment group will be asked to listen to music of their choice, three times a day, when they are experiencing pain after surgery, using a personal device which accesses on-line radio internet. These participants will be asked to rate and document pain intensity and pain distress before and after music listening, along with rating nausea and drowsiness (side effects which may be experienced from opioid analgesia taken), while in hospital and two days post-discharge. Twenty-five participants who comprise the control group will be asked to rate and document pain intensity and pain distress before and after scheduled mealtimes, along with rating nausea and drowsiness while in hospital and two days post-discharge. Medical records of pain ratings reported to nurses, opioid side effects reported, and analgesics taken by participants in both groups will be recorded from the participants hospital electronic medical record (EPIC). On the third discharge day from hospital a telephone interview will be conducted with study participants to evaluate their experience with music listening (treatment group), their overall pain experience (treatment and control groups), and their perception of personal balance between analgesia and opioid side effects (both groups). Treatment group participants who listened to music postoperatively reported experiencing less pain intensity and pain distress postoperatively in hospital and after discharge from hospital, but they did not report fewer opioid side effects (nausea and drowsiness) after surgery than participants who do not listen to music after surgery (control group participants). Further, treatment group participants did not use less opioid and non-opioid pain medication after surgery than participants who do not listen to music after surgery (control group). The study findings have implications for nurses in terms of developing evidence-based protocols involving music listening which can enhance acute surgical pain management with patients who undergo orthopedic surgery. ( en )
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In the series University of Florida Digital Collections.
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Includes vita.
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Includes bibliographical references.
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Description based on online resource; title from PDF title page.
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This bibliographic record is available under the Creative Commons CC0 public domain dedication. The University of Florida Libraries, as creator of this bibliographic record, has waived all rights to it worldwide under copyright law, including all related and neighboring rights, to the extent allowed by law.
Thesis:
Thesis (Ph.D.)--University of Florida, 2017.
Local:
Adviser: HORGAS,ANN L.
Local:
Co-adviser: YOON,SAUN-JOO.
Statement of Responsibility:
by Joanne Margaret Laframboise-Otto.

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UFRGP
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1 USE OF MUSIC LISTENING TO ENHANCE ACUTE SURGICAL PAIN MANAGEMENT WITH PATIENTS UNDERGOING ORTHOPEDIC SURGERY By JOANNE MARGAR ET LAFRAMBOISE OTTO A DISSERTATION PRESENTED TO THE GRADUATE SCHOOL OF THE UNIVERSITY OF FLORIDA IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE DEGREE OF DOCTOR OF PHILOSOPHY UNIVERSITY OF FLORIDA 2017

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2 2017 Joanne Margaret Laframboise Otto

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3 To my father and m other, Leo and Margaret Laframboise, who so faithfully believed in me and supported me throughout this educational endeavor. Thank you. I love you and miss you. Mom

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4 ACKNOWLEDGMENTS Words cannot adequately express the extent of my gratitude to my Dissertation Committee members, Dr Cynthia Garvan, Dr. Saunjoo Y oon, and Dr. Dale Campbell for their expertise, knowledge and support throughout this dissertation process. I am so very grateful to my Committee Chair Dr. Ann Horgas for her experti se in the research process and i n the study of pain. She trul y exemplifies a Nurse Scientist and I feel so privileged to have been her student. I am grateful to my family, my husband Bruce, my son Eddie, and my brother Charles for their continued love and support throughout this educational endeavor. Without their support I would not have been able to accompli sh this educational dream. Thank you Max, my German shepherd for all of your trips into my office to give me hugs.

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5 TABLE OF CONTENTS page ACKNOWLEDGMENTS ................................ ................................ ................................ .. 4 LIST OF TABLES ................................ ................................ ................................ ............ 8 LIST OF FIGURES ................................ ................................ ................................ ........ 10 LIST OF ABBREVIATIONS ................................ ................................ ........................... 11 ABSTRA CT ................................ ................................ ................................ ................... 12 CHAPTER 1 INTRODUCTION ................................ ................................ ................................ .... 15 Statement of the Problem ................................ ................................ ....................... 15 Back ground and Significance ................................ ................................ ................. 16 Conceptual Framework ................................ ................................ ........................... 18 Significance of the Study ................................ ................................ ........................ 21 Assumptions ................................ ................................ ................................ ........... 22 Purpose of the Study ................................ ................................ .............................. 22 Aims of the Study ................................ ................................ ................................ .... 22 Research Questions ................................ ................................ ............................... 23 Hypotheses of the Study ................................ ................................ ......................... 24 2 LITERATURE REVIEW ................................ ................................ .......................... 28 Postoperative Pain: An Overview ................................ ................................ ........... 28 Treatment of P ostoperative Pain ................................ ................................ ............ 28 Research ................................ ................................ ................................ ............. 29 Music as a Non Pharmacological Treatment Intervention ................................ ....... 39 Recent Studies Examining Music Therapy ................................ ............................. 39 Cardiovascular Surgery Studies ................................ ................................ ....... 40 Neurosurgery Studies ................................ ................................ ....................... 47 Abdominal (GI, Renal) Surgery Studies ................................ ............................ 50 Orthopedic Surgery Studies ................................ ................................ ............. 54 Transplant Surgery Study ................................ ................................ ................. 59 Recent Systematic Reviews of Studies Examining Music Therapy ........................ 61 Summary of Review of Recent Literature Examining Music Therapy ..................... 66 Indications for this Study ................................ ................................ ......................... 67 3 METHODS ................................ ................................ ................................ .............. 69 Sample and Setting ................................ ................................ ................................ 69 Inclusion Criteria ................................ ................................ ............................... 70

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6 Exclusion Criteria ................................ ................................ ............................. 71 Measures ................................ ................................ ................................ ................ 71 Demographic Characteristics ................................ ................................ ........... 71 Pain: Intensity and Distress ................................ ................................ .............. 71 Nausea and Drowsiness ................................ ................................ ................... 73 State Anxiety ................................ ................................ ................................ .... 73 Analgesic Usage ................................ ................................ .............................. 74 Music Listening Experience after Surgery Survey ................................ ............ 74 Overall Pain Experience in Hospital after Surgery Survey ................................ 75 Study Intervention: Music Listening ................................ ................................ .. 75 Procedure ................................ ................................ ................................ ............... 77 Preoperative Office Visit ................................ ................................ ................... 77 Evening of Surgery Hospital Visit ................................ ................................ ..... 78 Treatment group participants ................................ ................................ ..... 78 Control group participants ................................ ................................ .......... 80 Postoperative Days 1 and 2 Visits or Phone Calls ................................ ........... 81 Treatment group ................................ ................................ ........................ 81 Control group ................................ ................................ ............................. 82 Third Day Post Discharge from Hospital Follow Up Telephone Call ................ 82 Treatment group ................................ ................................ ........................ 82 Control group ................................ ................................ ............................. 83 Timeline for Contact with Study Participants ................................ ........................... 83 Data Analysis ................................ ................................ ................................ .......... 84 Institutional Review Board Study Approval ................................ ............................. 85 Study Enrollment and Data Diagram ................................ ................................ ....... 85 4 RESULTS ................................ ................................ ................................ ............... 92 Sample Characteristics ................................ ................................ ........................... 93 Main S tudy Results ................................ ................................ ................................ 93 Descriptive Analysis of Main Study Variables ................................ ......................... 93 Hospital ................................ ................................ ................................ ............ 94 Post Discharge ................................ ................................ ................................ 95 Relationship between State Anxiety and Postoperative Symptoms ........................ 96 Postoperative Pain Management Intervention: Nerve Block ................................ .. 97 Effect of Intervention on Postoperat ive Symptoms ................................ ................. 98 Hospital ................................ ................................ ................................ ............ 99 Post Discharge ................................ ................................ ................................ 99 Effects of Int ervention on Postoperative Analgesic Use ................................ ........ 100 Hospital ................................ ................................ ................................ .......... 100 Post Discharge ................................ ................................ ............................... 101 Perceptions of Music Intervention and Overall Pain Management ........................ 101 5 DISCUSSION ................................ ................................ ................................ ....... 131 Summary of Results ................................ ................................ .............................. 131 Strengths and Limitations of the Study ................................ ................................ 136

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7 Implications for Education ................................ ................................ ..................... 140 Implications for Practice ................................ ................................ ........................ 140 Im plications for Research ................................ ................................ ..................... 142 Conclusions ................................ ................................ ................................ .......... 145 AP P ENDIX A DEMOGRAPHICS SHEET ................................ ................................ ................... 147 B BOOKLETS: MUSIC GROUP: HOSPITAL & DISCHARGE ................................ 148 C BOOKLETS: CONTROL GROUP: HOSPITAL & DISCHARGE .......................... 158 D SURVEYS: MUSIC LISTENING & OVERALL PAIN EXPERIENCE .................... 168 E EPIC DATA SHEET: PAIN REPORTS TO NURSES & PAIN MEDS IN HOSPITAL ................................ ................................ ................................ ............ 170 F STATE ANXIETY INVENTORY (FORM Y 1) (SAMPLE USED WITH PERMISSION) ................................ ................................ ................................ ...... 171 REFERENCE LIST ................................ ................................ ................................ ...... 17 3 BIOGRAPHICAL SKETCH ................................ ................................ .......................... 178

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8 LIST OF TABLES Table page 3 1 Measurement Battery ................................ ................................ ......................... .. 88 3 2 Measurement Pro tocol ................................ ................................ ............................ 89 4 1 Characteristics of the Sample, Overall and by Group (N = 50) ............................. 103 4 2 Mean Post Surgical Pain Intensity Scores a in Hospital ................................ ......... 104 4 3 Mean Post Surgical Pain Distress Scores a in Hospital ................................ .......... 105 4 4 Mean Post Surgical Nausea Scores a in Hospital ................................ .................. 106 4 5 Mean Post Surgical Drowsiness Scores a in Hospital ................................ ............ 107 4 6 Type of Analgesic Medications taken by Study Participants in Hospital ................ 108 4 7 Mean Post Surgical Pain Intensity Scores a after Discharge ................................ .. 110 4 8 Mean Post Surgical Pain Distress Scores a after Discharge ................................ .. 111 4 9 Mean Post Surgical Nausea Scores a after Discharge ................................ ........... 112 4 10 Mean Post Surgical Drowsiness Scores a after Discharge ................................ ... 113 4 11 Type of Analgesic Medications taken by Reporting Study Participants after Discharge ................................ ................................ ................................ ......... 114 4 12 Correlations between State Anxiety and Postoperative Symptoms the Evening of Surgery in Hospital ................................ ................................ ....................... 116 4 13 Comparison of Post test Pain Intensity Scores between Music and Control Groups, Controlling for Pre test scores (ANCOVA) in Hospital ........................ 118 4 14 Comparison of Post test Pain Distress Scores between Music and Control Groups, Controlling for Pre test scores (ANCOVA) in Hospital ........................ 119 4 15 Comparison of Post test Nausea Scores between Music and Control Groups, Controlling for Pre test scores (ANCOVA) i n Hospital ................................ ...... 120 4 16 Comparison of Post test Drowsiness Scores between Music and Control Groups, Controlling for Pre test s cores (ANCOVA) in Hospital ........................ 121 4 17 Comparison of Post test Pain Intensity Scores between Music and Control Groups, Contro lling for Pre test scores (ANCOVA) after Discharge ................. 122

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9 4 18 Comparison of Post test Pain Distress Scores between Music and Control Groups, Controlling for Pre test scores (ANCOVA) after Discharge ................. 123 4 19 Comparison of Post test Nausea Scores between Music and Control Groups, Controlling for Pre test scores (ANCOVA) after Discharge .............................. 124 4 20 Comparison of Post tes t Drowsiness Scores between Music and Control Groups, Controlling for Pre test scores (ANCOVA) after Discharge ................. 125 4 21 Co mparison of Total Analgesic Usage (Opioid and Non Opioid) between Music and Control Groups in Hospital Independent t test ................................ ......... 126 4 22 Comparison of Reported Total Analgesic Usage (Opioid and Non Opioid) between Music and Control Groups after Discharge Independent t test ....... 127 4 23 Music Listening Experience after Surgery Survey Responses (N = 17) ............ 128 4 24 Ov erall Pain Experience after Surgery Survey by Group (N=36) ........................ 129 4 25. Overall Pain Experience in Hospital Survey Responses (N = 36) .................... 130

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10 LIST OF FIGURES Figure page 1 1 Balance between Analgesia and Side Effects (Parent Model of study) ................................ ................................ .......... 25 1 2 Multi Modal Intervention from the Theory of Balance betw een Analgesia and Side Effects (Good & Moore, 1996) applied to Use of Music Listening to Enhance Acute Surgical Pain Management with Patients Undergoing Orthopedic Surgery (Conceptual Model of study). ................................ .............. 26 1 3 Constructs, Theoretical Concepts, & Empirical Indicators (CTE) for Use of Music Listening to Enhance Acute Surgical Pain Management with Patients Undergoing Orthopedic Surgery. ................................ ................................ ........ 27 3 1 Timeline for Contact with Study Participants. ................................ ..................... 90 3 2 CONSORT Enrollment & Data Diagram ................................ ............................. 91 4 1 Type of Analgesic Usage among Study Participants in Hospital. ..................... 109 4 2 Type of Analgesic Usage among Reporting Study Participants after Discharge ................................ ................................ ................................ ......... 115 4 3 Length of Time Nerve Block in Place Postoperatively for Study Patients ......... 117

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11 LIST OF ABBREVIATIONS Drowsiness D ecreased level of consciousness occurring as an adverse effect or side effect of analgesic medication. EPIC A n electronic documentation system used for medical information in the hospital. Included in this system is information about medication administered to patients, and patient reports to nurses of pain intensity. Music intervention A planned and deliberate playing of patient selected music via an iPhone, iPad, or similar computer device provided by postoperative knee or hip joint replacement patients. Nausea An unpleasant, queasy, or wavelike sensation in the back of the throat, epigastrium, or abdomen that may or may not lead to the urge or need to vomit occurring as an adverse effect or side effect of analgesic medication. Orthopedic hip joint arthroplasty patient A person who has undergone either left or right orthopedic hip joint arthroplasty surger y. In this study, inclusion criteria limit the sample to non emergent orthopedic surgery patients. Orthopedic knee joint arthroplasty patient A person who has undergone either left or right orthopedic k nee joint arthroplasty surgery. In this study, inclusion criteria limit the sample to non emergent orthopedic surgery patients. Pain A n unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage. Pain distress The emotional distress experienced with pain. Pain intensity T he physical intensity experienced with pain. State anxiety A transitory emotional state that varies in intensity and fluctuates over time.

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12 Abstract of Dissertation Presented to the Graduate School of the University of Florida in Partial Fulfillment of the Requirements for the Degree of Doctor of Philosophy USE OF MUSIC LISTENING TO ENHANCE ACUTE SURGICAL PAIN MANAGEMENT WITH PATIENTS UNDERGOING ORTHOPEDIC SURGERY By Joanne Margaret Laframboise Otto December 2017 Chair: Ann Horgas Major: Nursing Science s In the hospital setting, nurses have the major responsibility of pain management and comfort care wit h patients undergoing surgery. Further, patients commonly look to nurses for help in relieving pain and achieving comfort. If not adequately managed, uncontrolled pain not only causes needless suffering, but can contribute to cardiovascular, respiratory, gastrointestinal, genitourinary, and neuroendocrine proble ms after surgery When implementing best practice s nurses need to determine if pain management strategies like music therapy can support the strengths and meet the needs of surgical patients, with the intentions of relieving physical pain, achieving psych ological comfort, and promoting recovery from surgery. The purpose of this study was to investigate the use of a music interventio n as an adjuvant with prescribed analgesics to help reduce acute surgical pain, analgesic usage, and analgesic side effects of nausea and drowsiness with patients undergoing orthopedic surgery. A convenience sample of 50 pa rticipants who had undergo ne either hip or knee joint replacement surgery at UF Health in Gainesville, FL comprise d the study sample. In this randomized cli nical trial twenty five participants were ran domly assigned to the

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13 treatment group and were asked to listen to music of their choice, three times a day, for 30 minutes duration, when they experienc ed pain after surgery, using a personal internet access device. These participants were asked to rate and document pain intensity and pain distress before and after music listening, and rat e nausea and dr owsiness (side effects which can be experienced from opioid analgesia taken), during the evening of surgery during postoperative days 1 and 2 in hospital and two days post discharge from hospital Twenty five participants w ho comprise the control group were asked to rate and document pain intensity and pain distress befor e and after scheduled mealtimes, (bre akfast, lunch, and dinner) along with rating nausea and drowsiness during the same time periods in hospital and post discharge. Electronic medical records (EPIC) of opioid and non opioid analgesics taken by participants were recorded, as were participant reports of anal g e sics t aken after discharge recorded in their log booklets On the third discharge day from hospital a telephone interview w as conducted wit h study participants to survey their experience with mus ic listening (treatment group) and their ov erall pain experience in hospital after surgery (treatment and control groups) Results of the study indicated that participants who listened to music after surgery ( treatment group music plus analgesic medications ) reported experiencing less pain intensity and pain distress postoperatively in hospital and after discharge from hospital, but they did not report fewer opioid side effects (nausea and drowsiness) after surgery compared to participants who do not listen to music after surgery (control gr oup analgesic medications alone ). Further, treatment group participants did not use less opioid and non opioid pain medication after surgery compared to participants who do

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14 not listen to music after surgery (control group). The study findings have imp l ications for nurses to develop evidence based protocols involving the strategic use of music listening as an adjuvant therapy, along with analgesic medications, to enhance acute surgical pain management with patients i n both in the hospital and discharge ( home) settings.

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15 CHAPTER 1 INTRODUCTION Statement of the Problem According to the Centers for Disease Control and Prevention (CDC) in the United States an estimated 48 million surgical procedures are performed each year in the inpatient hospital setting, with an additional 53.3 million surgical and non surgical procedures performed during ambulatory surgery visits (CDC Statistics, 2010). Depending on the surgical procedure, the symptom of pain is frequently experienced by patients after surgery ( Gordon et al., 2016). If not adequately managed, acute pain can have deleterious effects, both physiological and psychological, on patients' recovery from surgery ( Sinatra, 2010 ). In addition to analgesic medications, the Agency for Healthcare Research and Quali ty (AHRQ) recommend s for acute surgical pain management the use of cognitive behavioral modalities such as relaxation, music, di straction, and image ry (Carr & Jacox, 2006). T hese cognitive behavioral modalities are also recommended for use with surgical patie nts by the American Pain Society and related pain professional organizations in their Clinical Practice Guidelines ( Chou et al., 2016). These modalities have been shown to improve the management of pain and anxiety with surgical patients, and possibl y reduc e the am ount of pain medication used by patients after surgery ( Chou et al., 2016; Gordon et al., 2016) More specifically, studies examining the effects of music on acute surgical pain have shown music to help re duce anxiety and pain intensity a nd decrease opioid intake with surgical patients in the perioperative period (Gooding et al., 2012; Hole et al., 2015 ).

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16 Background and Significance It is the professional and ethical responsibility of nurses and other heal th care pro viders to assess, inte rvene and evaluate pain with surgical patients and to relieve acute surgical pain, thereby minimizing the deleterious effects of unrelieved pain. Further, nurses spend more time w ith patients than any other health care pro viders and therefore are i n an ideal position to implement additional strategies besides offering prescribed analgesics for pain relief Cognitive behavioral modalities such as music have been recomm ended for use with surgical patients for acute pain management by the Agency for Hea lthcare Research an d Quality (AHRQ) for years and need to be offered as adjuvants, along with analgesic medications, for postoperative pain relief. Although acute pain is a predictable part of the postoperative experience, inadequate management of pain is not un common and this in turn can have significant implications. Unrelieved postoperative pain can contribute to cl inical and psychological problems with patients resulting in nega tive clinical outcomes including problems such as deep vein thrombosis, pulmonary embolism, coronary ischemia, myocardial infarction pneumoni a, poor wound healing, insomnia, anxiety and depression (Sinatra, 2010 ). Associa ted with these clinical problems are ec onomic and medical issues such as extended lengths of hospital st ay and patient dissatisfaction with medical and nursing care ( Sinatra, 2010 ). Pharmacological management with opioid analgesics continues to be the mainstay treatment for acute surgical pain. However, opioid analgesics can impair the postoperative rec ov ery of surgical patients because of their sedative and emetic side effects. Practitioners who advocate for the use of complementary medical modalities

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17 support the use of non pharmacological adjuvants such relaxation and music for cal symptoms inc luding pain. Recently published systematic reviews have found evidence among related published studies which support using music to help decrease perioperative anxiety, postoperative pain and reduce opioid analgesic usage with surgical p atients (Cepeda et al., 2013; Economidou et al., 2012; Hole et al., 2015; Matsota et al., 2013 ; Sin & Chow, 2015 ) In recently published studies, music listening a s an in tervention has been found to decrease postoperative pain and in some cases, analgesic usage postoperatively in adult surgical patients (Allred, Myers, & Sole, 2010; Chen et al., 2015; Cutshall et al., 2011; Good et al. 2010 ; Ignacio et al., 2012; Jose et al., 2012; Lin et al., 2011; Lui & Petrini, 2015; Madison & Silverman, 2010; Mondanaro et al., 2017 ; Ozer et al., 2013; Vaaj oki et al., 2012 ). These studies will be review ed in the following chapter. In summary, there is good empirical evidence to support the use of music as an effective adjuvant to help reduce postoperative pain with adult surgical patients, and some evidence to support the use of music to help decrease analgesic usag e (The Joanna Briggs Institute, 2010). However, there are a number of me thodological differences among recently published studies. For example in published studies, use of music as an i ntervention varied significantly among these studies in terms of timing (when music was introduced and used during the study), dose (time allotment recommended or required for listening to music in minutes duration), frequency (number of times recommended or required for listening to the music intervention and specified time or times suggested for its use during the postoperative period), choice (either patient driven or investigator driven), and type of music (ranging from culturally sensitive

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18 offerings to music varying in tone, rhythm, and beat). Also, s tudies failed to report controlling for the number of times study participants actually listened to the music intervention. In addition, p ostoperat ive pain was measur ed in these studies at different times during the postoperative period. These methodological issues can make m eaningful comparisons among published studies somewhat difficult. R ecommendations for future research often suggest that music timing, dose, freq uency, choice, and type of music be examined as a means of determining the best or optimal use for implementation with surgical patients (Good et al., 2005, 2010). These published studies examined outcomes of pain and anxiety reduc tion when using music for postoperative pain managemen t with patients in the hospital setting N one of t hese studies examined the use of music for managing acute surgical pain post discharge from hospital. Surgical p atients are now being discharged from hospital earlier due to improved surgical techniques and to a health care system agenda supporting outpatient and home care for surgical patients. P atients experience significant levels of pain in the early postoperative period both in hospital and when discharged from hospi tal Therefore, it is necessary to empirically examine the use o f non pharmacological adjuvants such as music for acute surgical pain relief with patient s post discharge from hospital. In t his study the investigator examin ed the use of music as a non pharma cological adjuvant, along with prescribed analgesic, to help managing acute surgical pain with orthopedic surgery patients in both the hospital setting and after discharge from hospital. C onceptual Framework The conceptual model for this research study was the theory of Balance between Analgesia and Side Effects (Good & Moore, 1996). This middle range theory

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19 was chosen to guide this research study because it is a tested prescriptive theory for pain relief and it guide d this researcher to empirically identify effective pain relief practices for orthopedic surgery patients. The Good and Moore (1996) theory of etween Analgesia and Side Effects is a nursing pain management theory which proposes that multimodal i ntervention, attentive care, and patient education are needed for optimal pain relief. This theory is comprised of eight intervention concepts in three propositions that predict the outcome concept of balance (Fig ure 1 1). The propositions predict that ( 1) multimodal interventions, (2) attentive pain management, and (3) patient participation contribute to the balance betwee n analgesia and side effects. Good (1998) purported that this balance is important because when opioids are used, the risk of side ef fects such as nausea, itching, and drowsiness also increases and should be countered. Further, Good (1998) indicated "the reduction of severe pain and control of medication side effects are important for ethical, humanitarian, and economic reasons" (p. 12 0). The structure of the theory of Balance between Analgesia and Side Effects (Good & Moore, 1996) is shown in Figure 1 1, with concepts relationships, and propositions. The propositions from this theory are as follows: 1. Multimodal intervention: gi ving potent pain medication along with pharmacologic and non pharmacologic adjuvants contributes to achieving a balance bet ween analgesia and side effects. 2. Attentive care: regular pain assessment, regular side effect assessment, identification of unreliev ed pain and unwanted side effects, and a process of intervention, reassessment, and re intervention contributes to a balance bet ween analgesia and side effects. 3. Patient participation: patient teaching and patient goal setting for pain relief contribute to achieving a balance between analgesia and side effects (Good, 1998).

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20 Development of hypotheses fr om theoretical statements begin with deduction of specific research concepts of inte rest from the broader theoretical constructs (Good, 1998). In this pain theory, Good (1998) referred be deduced from the theoretical construct of a balance between analgesia and side effects: decreased pain and decrea sed side effects from opioids (see Figure 1 2). Further, more specific concepts can be deduced from these constructs; for example, pain intensity and pain distress from the construct of pain, and nausea and drowsiness from the construct of side effects ( see F igure1 3). Good (1998) explained that after research outcomes have been identified, specific research intervention concepts can be deduced. For example, with regard to the proposition of multimodal interventions and for the construct of non pharmaco logic adjuvant, the effectiveness of a music intervention on pain in addition to analgesic usage can be tested (Good, 1998). The mechanism for the effect of music can be found in (1965, 1 996) Gate Control Theory of Pain in that mental attention to a distracti ng stimulus, for example, music can modify the transmission of potentially painful impulses in the spinal cord. Music provides input into the central nervous system that allows the patient to attend to the music rather than to the pain. The pleasant and familiar stimulus of music relaxes muscles, distracts thoughts from pain and illness, evokes an effective response via descending nerve fibers, and closes the gate to perception of the sensory and affective components of pain (Good et al., 2005). The reduced tension also decreases the sympathetic nervous system stimulation of the hypothalamus, which activates endogenous opiates to inhibit the transmission of impulses that resu lt in pain (Good et al., 2005).

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21 Based on Good & Moore 's (1996) conceptual framework and a preliminary review of the literature, it was proposed that a music intervention, used as a n on pharmacological adjuvant, would reduce postoperative pain and decrease anal gesic usage. In addition, it was proposed that music would decrease analgesic side effects (nausea and drowsiness) among orthopedic surgery patients due to decreased ana lgesic usage. Specific variables music intervention include d pain inten sity pain distress, state anxiety, opioid and non opioid analgesic usage, and a nalgesia side effects of nausea and drowsiness. Figures 1 2 & 1 3 illustrate the operationalization and adaptation of the theory of Balance between Analgesia and Side Effects (Good & Moore, 1996) in this research study. Significance of the Study This study investigate d the use of a music intervention on pain intensity, pain distress nausea, drowsiness and analgesic usage in a sample of orthopedic surgery patients during th e postoperative period in hospital and post discharge from hospital. A follow up interview was conducted with study participants to gather additional information regarding their perceptions of using music to h elp relieve postoperative pain and their per ceptions of their overall pain experience in hospital after surgery. It was proposed that the positive effects of a music intervention on pain intensi ty, pain distress, nausea, drowsiness and analgesic usage would reduce the deleterious effects of unreli eved postoperative pain with study participants. Examining how the effective use of postoperative analgesics and music therapy can balance analgesia (pain relief) and analgesic side effects (for example, nausea and drowsiness) with post operative patients is important for nurses to determine so nurses can prescribe effective interventions for

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22 postoperative pain management that will result in positive outcomes for surgical patients. Assumptions This research was based on s everal assumptions. First, it wa s assumed that the human response to pain is multifactorial and interrelated, wi th significant individual variation. Second, it was assumed that humans develop a pain response to noxious stimuli. Third, it was assumed that the measurement tools used were valid and reli able instruments. Fourth, it was assum ed that study participants answer ed the self reporting measurement tools of Pain Intensity Scale ( NRS ), Pain Distress Scale ( NRS ) the STAI For m Y 1 State Anxiety Scale, and the numerical rating s cales used for Nausea and Drowsiness truthfully. Purpose of the Study The purpose of this study was to investigate the use of a music intervention as an adjuvant with prescribed analgesia to help reduce postoperative pain with patients undergoing knee or hip joi nt replacement surgery. Aims of the Study This research study was a prospective randomized trial that evaluated the use of a music intervention along with prescribed analgesia to reduce postoperative pain with patients who had undergone knee or hip join t replacement surgery. The specific aims of this study were: 1. To determine the effect of music listening on pain intensity, pain distress, opioid side effects of nausea and drowsiness, and opioid and non opioid analgesic usage in the early postoperative pe riod (evening of surgery, days one and two postoperatively, and two days post discharge from hospital);

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23 2. surgery, and their perceptions of their overall pain experience in hospital after surgery. Research Questions Question 1 What are the levels of pain intensity, pain distress, opioid side effects of nausea and drowsiness, and opioid and non opioid analgesic usage among adult patients undergoing joint arthroplasty surgery the even ing of surgery, during the first two postoperative days in hospital, and during the first two days post discharge from hospital? Question 2. In adults undergoing joint arthroplasty surgery, is state anxiety associated with postoperative symptoms of pain ( intensity and dist ress), nausea, and drowsiness the evening of surgery? Question 3. In adults undergoing joint arthroplasty surgery, is a combined intervention (music therapy plus analgesic medication s ) more effective than analgesic medication s alone in reducing postoperative symptoms (pain intensity, pain distress, nausea, drowsiness) the evening of surgery, during the first two postoperative days in hospital and during the first two days post discharge from hospital? Question 4. In adults undergoing joint arthroplasty surgery, do participants who receive the combined intervention (music therapy plus analgesic medications) use less opioid and non opioid analgesics than those participants who receive analgesic medications alone dur ing the first two postoperative days in hospital and during the first two days post discharge from hospital? Question 5. of their music listening experience after surgery (music group), and their perceptions of t heir overall pain experience in hospital after surgery (music and control groups)?

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24 Hypotheses of the Study Hypothesis 1. State anxiety will be significantly associated with higher levels pain intensity, pain distress, and nausea, and lower levels of drows iness in study pa tients the early postoperative period (evening of surgery). Hypothesis 2. Controlling for pre test symptom levels, (pain i ntensity, pain distress, nausea and drowsiness scores ) p a tients who listened to music after surgery as an adjuvant to analgesic medications will report significantly lower pain intensity, pain distress, nausea, and drowsiness symptoms after listening to music compared to pa tients who received analgesic medications alone t he evening of surgery, during the first two postoperative days in hospital and during the first two days post discharge from hospital. Hypothesis 3. Pa tients who listened to music after surgery as an adjuvant to analgesic medications will use significantl y less opioid and non opioid analgesics compared to pa tients who received analgesic medications alone during the first two postoperative days in hospital and during the first two days post discharge from hospital.

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25 Figu re 1 1. Effects (Parent Model of study)

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26 Figure 1 2. Multi Modal Intervention from the Theory of Balance between Analgesia and Side Effects (Good & Moore, 1996) applied to Use of Music Listening to Enhance Acute Surgical Pain Management with Patients Undergoing Orthopedic Surge ry (Conceptual Model of study). Pharmacological Adjuvants (Non Opioid Analgesics) Potent Pain Medication (Opioid Analgesics) Non Pharmacological Adjuvants (Music Intervention) Balance Between Analgesia and Side Effects ( Component Outcomes: *decreased pain *decreased side effects of opioids )

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27 Construct Potent Pain Medications Pharmacological Adjuvants Non Pharmacological Adjuvants Enhanced Post operative Pain Management Theoretical Concepts Opioids: prescribed administered equianalgesic dose (m orphine equivalent) Non Opioids: prescribed administered equianalgesic dose (a cetaminophen equivalent) Music Intervention : study treatment Pain Reduction /Relief : pain intensity pain distress Analgesic Usage Reduction : opioids & non opioids given Decreased Side Effects of Analgesics (Nausea, Drowsiness) following surgery Empirical Indicators Opioids: # doses administered during select postop period s ; total amount in equianalgesic dose administered during select postop period s Non Opioids: # doses administered during select postop period s ; total amount in equianalgesic dose admin istered during select postop period s Music Intervention: patient choice of music music listening 3 x per day, 30 minutes duration during select postop period s Pain Reduction: worst/right no with NRS during select postop period s ; Pain with NRS during select postop period s Analgesic Usage: total amount in equi analgesic dose administered during select postop period s Side Effects: NRS during select postop period s ; Dr NRS during select postop period s Figure 1 3. Constructs, Theoretical Concepts, & Empirical Indicators (CTE) for Use of Music Listening to Enhance Acute Surgical Pain Management with Patients Undergoing Orthopedic Surgery.

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28 CHAPTER 2 LITERATURE REVIEW Postoperative Pain: An Overview Postoperative pain is an unpleasant symptom that is commonly experienced by surgical patients. It has been reported that 77 98% of surgical patient s experience postopera tive pain, and o f these, 40 80% report moderate to severe pain, and half (40 50%) further report unsatisfactory pain management (Lin, 2011). Moderate to severe acute surgical pain not well managed after surgery can contribute to the development of chroni c persistent surgical pain problems (Bruce & Quinlan, 2011). Un controlled postoperative pain contributes to respiratory, cardiovascular, gastrointestinal, genitourinary, muscular, endocrine, and metabolic system complications for patients after surgery ( S inatra, 2010 ). For the patient, t his can result in prolonged hospitalization and delayed recovery from surgery ( Sinatra, 2010 ). Further, the Joint Commission on the Accreditation of Health Care Organizations ( TJC) requires that pain be assessed and manag ed for all hospitalized patients. This accreditation requirement stresses the importance that health care pro viders should place on adequately managing pain with hospitalized patients. In nursing practice, pain management is considered a fundamental and important component of effective patient care. Treatment of Postoperative Pain In order to achieve effective pain control after surgery, it is widely recommended in clinical practice guidelines that nurses use non pharmacological measures such as relaxation, guided imagery, music, and distraction along with administering prescribed analgesics to holistically and effectively manage the sur (Carr et al., 1992 ; The Joanna Briggs Institute, 2011) These measures are be lieved to

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29 be useful because some patients can experience significant adverse effects and side effects with prescribed opioid analgesic use. While analgesics are prescribed to primarily manage the physiological component of pain, non pharmacological measu res are believed to manage the emotional and psychological components of the surgical Music was chosen as the intervention for use in this study. The rationale for choosing music was music has additional be nefits that other cognitive behavioral modalities may not in that it provides complex sounds including characteristics such a s pitch, rhythm, and tempo that evoke personal meaning and often pleasant memori es for individuals (McCaffery & Good, 2000). Musi c as a Treatment Intervention: Research Since 1995, noted nurse researcher and theorist Dr. Marion Good has developed a body of theoretical and research knowledge regarding the efficacy of complementary therapies for pain management and stress. Her scholarly work which spans two decades, is bas ed on best practices and has influenced health care policy within and outside of the United States. In her body of research Dr. Good has developed complementary or non pharmacological nursing interventions using relaxation training, music therapy, and pat ient teaching for pain management for use with a variety of patient populations. Dr. Good and colleagues have examined the use of culturally appropriate variations in music therapy for use with patients from Taiwan, Korea, and Thailand. In 1996, along w ith Dr. Shirley Moore, Dr. Good developed the theory of Balance between Analgesia and Side Effects This theory was one of the first middle range prescriptive theories in nursing and pain management (Good & Moore, 1996). In her subsequent research, Dr Good and colleagues have tested constructs of her theory

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30 in studies examining non pharmacological nursing interventio ns to manage pain and stress. Findings from research studies in which she examined the use of relaxation and music therapy to manage pai n and stress with various patient populations are summarized and presented in chronological order below. dissertation work, she reported on an experimental study she conducted in which she examined the effects of jaw relaxation and music, administered individually and combined, on the sensory and affective components of pain and narcotic intake with a sample of 84 subjects during first ambulation effort on postoperative day one followin g abdominal surgery. She reported that the interventions were neither effective nor significantly different from one another statistically during patient ambulation. The relaxation intervention tape was used the least among relaxation group participants, perhaps, as Good (1995) offered, because it was less interesting than the music or combination tapes used in the study. Anecdotally, Good (1995) reported that experimental group participants who used relaxation and music, either individually or combined, did indicate that during the first two da ys after surgery, participants found the interventions helpful for relieving sensation and distress from postoperative pain. She reported that the majority o f study participants found the intervention tape modera tely or very helpful (76%), felt it reduced pain sensation and distress from pain (89%), indicated that they would use it again for surgery (92%), and would recommend it to others (95%). Good (1995) offered a number of factors as possible reasons for the difficulty in demonstrating effect in the study including higher and more vulnerable pain experienced by postoperative patients during first ambulation effort, as well as the

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31 difficulty of initiating the study intervention techniques during the complex ac tivity of ambulation. In 1998, Good and Chin published a study in which Western music was tested for its effectiveness in reducing postoperative pain, and explored the acceptability and preferences for this music with a sample of 38 Taiwanese subjects who had undergone major abdominal surgery. Using a pretest posttest experimental design, pain sensation and distress of pain were measured using visual analog scales. Treatment group participants received tape recorded music and choose from among 5 types of Western music while control group participants received usual care. On postoperative day 1 and day 2, the effectiveness of the tape recorded music was examined with participants during 15 minutes of rest in bed. On postoperative day 3, participants were interview ed to determine their liking of the music, its calming effects, and the helpfulness of the music in reducing pain after surgery. Results from their study indicated that participants who listened to music experienced a greater decrease in pain di stress on p ostoperative day 1 (p<0.05) ( not on postoperative day 2) and a greater decrease in pain sensation on postoperative day 2 (p<0.05) (but not on postoperative day 1) than participants who did not listen to music. Further, they reported that partic previous studies conducted by Dr. Good in the United States. They reported music to be helpfulness in relieving pain sensation and pain distress from surgery; h owever, fewer Taiwanese participants f ound the Western music choices calming, and instead chose harp music over jazz music. These investigators concluded that findings from their study support the use of culturally acceptable music in addition to analgesic

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32 medication for the relief of posto perative pain with Taiwanese patients who had undergo ne abdominal surgery (Good & Chin, 1998). In 1999, Good and colleagues published a study reporting on a large randomized clinical trial conducted to determine the effect of jaw relaxation, music and the of 500 subjects during ambulation and rest on postoperative days 1 and 2 after major abdominal surgery. They measured pain and distress at four time periods o n postoperative days 1 and 2: before preparing for ambulation, after preparing for ambulation, after ambulation, and after recovery from ambulation. Good and colleagues (1999) found that in all three treatment groups participants reported experiencing significantly less sensation and distress from pain than control group participants at three of the four ambulation times: before preparing for ambulation, after preparing for ambulation, and after recovery from ambulation on both postoperative days (p=0. 028 0.000). Specifically, combination (jaw relaxation and music) group participants reported significantly less sensation and distress from pain than control group participants at these same periods on both postoperative days (p=0.035 0.000), and rel axation and music group participants reported significantly less sensation and distress f rom pain than control group participants at these same time periods on both postoperative days (p=0.022 0.000). They found that after ambulation, participants using relaxation did not have significantly less pain than control group participants on postoperative days 1 and 2, and participants using music did not have significantly less pain than control group participants on postoperative day 2. In explaining these f indings they offered that there was likely a decrease in mastery of the

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33 study interventions from pre to post ambulation, suggesting th e need for reminders to help patient s focus on the intervention during this painful activity (Good et al., 1999). The in vestigators indicated the results of their study supported Good and Moore (1996) pain management theory in that with patients, non pharmacological adjuvants along with analgesic medications reduce pain more than ana lgesic medications alone. In 2002, Go od and colleagues published a study reporting on a randomized clinical trial conducted to investigate the effect of three non pharmacologic nursing interventions: relaxation, music, and the combination of relaxation and music on pain with a sample of 311 women subjects during ambulation and rest on postoperative days 1 and 2 after gynecologic surgery. They found that participants in the three treatment groups reported experiencing significantl y less sensation and distress from pain than control group parti cipants (p=.022 .001). They determined that participants who received the interventions plus routinely ordered patient controlled analgesics (PCA) had 9% to 29% less pain than control group participants who used PCA alone. The investigators offered that the results of t heir study supported theory of pain management theory that adjuvant use of non pharmacologic methods of pain relief result in less pain than use of analgesic medications alone In 2003, Phumdoung and Good published a study reporti ng on a randomized clinical trial conducted to examine the effects of mu sic on sensation and distress from pain with a sample of 110 first pregnancy Thai women during the active phase of labor. Participants in the music group listened to soft music withou t lyrics for 3 hours starting early in the active phase of labor. They found that music group participants reported experiencing significantly less sensation and distress from pain than did control group

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34 participants (p<.001, effect size .12 .15). They o ffered that in their study, music a mild to moderate strength intervention consistently provided significant relief from severe pain across 3 hours of labor, and that music should be provided to laboring women during their active phase when contractions are strong and women suffer. In 2004, Voss, Good, and colleagues published a study reporting on a randomized clinical trial conducted to determine the effectiveness of non pharmacological methods (sedative music and scheduled rest) in reducing anxiety and pain during chair rest with a sample of 61 subjects who had undergone open heart surgery. Using a three group pretest posttest experimental design, participants were randomly assigned to receive sedative music, scheduled rest, or treatment as usual durin g chair rest. They found that participants in the sedative music and scheduled rest groups repo rted significantly less anxiety, sensation and distress from pain than treatment as usual (control) participants (p<0.001 0.015). Further, they found that p articipants in the sedative music group reported significantly less anxiety, sensation and distress from pain than rest group or treatment as usual (control) group participants (p<0.001 0.006). They concluded that in their study, sedative music used as an adjuvant along with analgesic medication s was more effective than scheduled rest or treatment as usual to decrease anxiety and pain in open heart surgery patients during first time chair rest in th e early postoperative period. In 2005 Good and collea gues published a study reporting on a randomized control trial conducted to determine the effectiveness of three non pharmacological nursing interventions (relaxation, chosen music, and their combination), in reducing pain sensation and distress in a sampl e of 167 patients during ambulation and rest on

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35 postoperative days 1 and 2 after intestinal surgery. They found that all three treatment group participants reported significantly less pain sensation and distress than control group participants on both pos toperative days after rest and at three of six ambulation efforts during these postoperative days (p=.024 .001). In explanation of these mixed findings they offered that in their study, participants reported large variations in pain experienced in add ition to having difficulty relaxing while returning to bed. The investigators indicated that study evidence at most data points supported the Good and Moore (1996) theoretical proposition that non pharmacological modalities in addition to analgesics, a re more helpful for satisfactory pain relief than u se of analgesics alone. In 2006, Siedliecki and Good published a report on a rando mized controlled clinical trial depression and disa bility comparing the effects of researcher provided music (standard music) with subject preferred music (patterning music) for a sample of 60 working age African American and Caucasian adult subjects with chronic non malignant pain (CNMP). Study particip ants listened to either researcher provided music or subject preferred music for 1 hour each day over a period of 7 days, and were asked to keep a diary of their music listening experience and pain experience each day. Control group participants were aske d to keep a diary of their pain experience each day. Pain was measured using the short form McGill Pain Questionnaire. They found that music group participants reported feeling more power (p=0.048), less pain (p=0.002), less depression (p=0.002), and les s disability (p=0.024) than control group participants. However, there were no statistically significant differences between the two music rts on these study measures. The investigators

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36 offered that findings in their s tudy suggested that with individuals who experience chronic non malignant pain, music interventions altered patterns of pain, depression, and disability associated with CNMP, and music interventions facilitated the perception of power among study participa nts. In 2008, Good and Ahn published a study reporting on a randomized clinical trial conducted to examine the effects of music on pain after gynecologic surgery with a sample of 73 Korean women, comparing pain relief between women who chose American or Ko rean music. Using a quasi experimental pretest posttest design, Korean women assigned to the experimental group were instructed to choose among Korean (ballads and religious and popular songs) and American (soft slow piano and orchestra) music, and were i nstructed to listen to their chosen music at four time points the morning and afternoon of postoperative days 1 and 2. Control group participants were instructed to rest in bed during these same four time points. Pain was measured in this study using sen sation and distress visual analog scales. They found that two thirds of women in the music group chose Korean music and one third of women chose American music. Among these music group participants, there were no differences in reported pain sensation and distress, and both were effective in rel ieving postoperative pain. When comparing music group participants and control group participants, there was a significant difference in reported pain sensation and distress at three of the four postoperative time p oints (p=0.001 0.040). The investigators determined that resu lts from their study support Good and Moore (1996) nursing pain management theory in that a balance of pharmacologic and non pharmacologic methods provided up to 23% better pain management than analgesics alon e. Further, they indicated their study

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37 supported offering music that would include culturally and religious based music choices to women after gynecologic surgery to aid in reliev ing their postoperative pain. In 2010, Good and colleagu es published a study reporting on a large randomized clinical trial conducted to examine the effectiveness of the use of audiotaped patient teaching for different combinations of non pharmacological pain treatments: audiotaped preoperative patient teachin g for pain management (PT), audiotaped jaw relaxation technique and music (RM), and a combination of audiotaped preoperative patient teaching for pain management and jaw relaxation and music (PTRM) with a sample of 517 subjects who had undergone abdominal surgery. Their study is described in detail in the upcoming literature review sec tion entitled, Recent Studies Examining Music Therapy. Lastly, in 2013, Good and colleagues published a study reporting on determining whether two interventions, preoperative patient teaching (PT) for pain management and relaxation/music (RM), reduced cortisol levels, an indicator of stress, with subjects who had undergone abdominal surgery. Their data was a secondary analysis from the large randomized clinical trial of the e ffects of these interventions on pain, a parent study referred to as the Pain Study (N=517) (Good et al., 2010). Subjects with complete data at pre and post test were analyzed in this secondary analysis. As background information to better understand t he relevance for nurses to study the clinical variable of cortisol level empirically, the following explanation was provided by Dr. Good : I n surgical patients, increased cortisol level is a physiological response of the body to the creation of a surgical incision, excision of body tissue during surgery, trauma to the body tissue experienced during surgery, and pain associated with major

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38 surge ry. Cortisol levels are an indicator of the physiological and psychological stress of surgery and postoperative pain, and can result in patients being more susceptible to infection and complications after surgery (Good et al., 2013). Therefore, it behoov es nurses to study this clinical variable empirically and examine nursing interventions that would aid in not only relieving postoperative pain but have a significant physiological effect on decreasing cortisol levels with surgical patients. Using a 2 x 2 factorial design, Good and colleagues (2013) compared groups for PT effects and RM effects on cortisol levels. From the parent study (Good et al., 2010), participant salivary cortisol levels (N=205) were measured before and after 20 minute tests of the interventions in the morning and afternoon of postoperative day s 1 and 2. The investigators reported there was no empirical evidence to suggest a PT effect or RM effect on cortisol levels in either the morning or afternoon of postoperative days 1 and 2 among study participants. They found that participants varied in their stress/cortisol responses to the two nursing interventions (PT & RM). They suggested that because there were no adverse effects noted in their cortisol/stress study, nurses can offer relaxation and choice of music to patients on postoperative days 1 and 2 to rel ieve pain and stress. T hey recommended that nurses continue to use relaxation training and music therapy to relieve postoperative pain with surgical patients based on the find ings of the ir parent P ain Study (Good et al., 2010). close to two decades, provides a sound empirical base to support the clinical use of relaxation training and music therapy as non pharmacological treat ment interventions nurses can use to help reduce postoperative pain with surgical patients. Further, in her empirical work she

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39 tested the ef ficacy and found support for use of her pain management theory Balance between Analgesia and Side Effects (Good & Moore, 1996) to guide nursing research on pain management. It is noteworthy that among her many studies she did not specifically investigate the effect of non pharmacological treatment interventions on the incidence or intensity of side effects (for exa mple, nausea, itchiness, drowsiness) that can be experienced by patients when taking opioid analgesics to relieve pain. This observation is consistent with e mail correspondence between Dr. Good and this investigator (dated 07/14/14). Therefore, explorin g this gap in the use of her theory Balance between Analgesia and Side Effects (Good & Moore, 1996) is an additional and further step needed to determine the efficacy of this theory for use in nursi ng research and pain practice. Music as a Non Pharmacol ogical Treatment Intervention In the empirical literature, relaxation, guided imagery, music therapy, therapeutic touch, and massage are examples of non pharmacological measures that have been examined for us e with surgical patients to help reduce postoper ative pain. This re view was limited to the past seven years and focuses on recent studies and systematic reviews that have examined the use of music therapy in reducing postoperative pain with adult surgical patients. Recent Studies Examining Music Thera py Cognitive behavioral approaches for pain management have be en studied by investigators using a variety of surgical patients. Music therapy, a cognitive behavioral approach, is believed to decrease anxiety in the perioperative period and reduce pain in the postoperative pe riod among surgical patients. A number of investigators examined the use of music therapy as an adjuvant intervention in reducing postoperative pain and

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40 reducin g analgesic usage with surgical patients. S tudies published within the past seven years that examined the use of music therapy to reduce postoperative pain in adult sur gical patients will be synopsized below. These studies will be presented by type of surgery. Cardiovascular Surgery S tudies Lui and Petrini (2015) examined the effective ne ss of music listening on pain, anxiety, and vital signs among pat ients after thoracic surgery. They conducted a randomized controlled trial with repeated measures design at two tertiary teaching hospital in China. The convenience sample included 112 patients who were randomly assigned to experimental (n=56) (odd admission day numbers) or control (n=56) (even admission day numbers) groups. E xperimental group participants received standard care and a 30 minute soft music interven tion for 3 days, while control group participants received only standard care. Outcome m easures included pain (using the Faces Scale) anxiety (using the State Trait Anxiety Inventory) vital signs (blood pressure, heart rate, and respiratory rate), patient contro lled analgesia (PCA) (opioid drug dosage used was counted) and diclofenac sodium (a non steroidal anti inflammatory drug) suppository use (consumption in milligrams used). Experimental group participants were visited on postoperative day 1, and pre test data (pain, anxiety, vital signs) collected, and provided a 30 minute music session. Soft music with 60 80 beats per minute or less was offered to participants via a MP3 (digital audio) player with earphones. After listen ing to music, post test measures were obtained with participants. Study investigators continued pre and post test measures with the music intervention on postoperative days 2 and 3 with experimental group participants. Control group participants received only standard care (not describ ed by investigators) and stated only

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41 that the same pre test and post test tests were conducted with participants in this group. After all data were collected, the inves tigators reported of fering music to control group participants if wanted. Descriptive non parametric (Chi Squared Test), and parametric statistics (I ndependent t T ests, Repeated Measures of Analysis of Variance) were used to analyze the study data. Results of this study indicated no significant differences between demographics and baseline (pre test) measures on study variables among participants. E xperimental group participants did report significant decrease s in pain 2=5.498, p=0.019) anxiety (F=5.560, p=0.02) systolic blood pressure (F= 4.495, p=0.04) and hear rate (F=4 .379, p=0.04) postoperative days 1, 2 and 3, compared to the control group participants but no significant differences were found between group participants in diastolic blood pressure, respiratory ra te opioid analgesic usage (via PCA) and diclofena c sod ium suppository use. These investigators concluded that f indings from their study provide d further evidence to support the practice of using music therapy to reduce postoperative pain and anxiety, and lower ing systolic blood pressure and heart rate in patients after thoracic surgery (Lui & Petrini, 2015). Their lack of significant findings for music lowering diastolic blood pressure, respiratory rate, and opioid analgesic usage was consistent with some past st udies but inconsistent wi th other past studies cited in their work. Ozer and colleagues (2013) examined the effect of listening to personal choice of music on self reported pain intensity and physiological parameters of blood pressure, heart rate, oxyge n saturation, and respiratory rate in patients undergoing open heart

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42 surgery (coronary bypass graft surgery or valve replacement surgery). Their quasi experimental design study was conducted using a convenience sample of 87 adult subjects: 44 music grou p participants and 43 control group participants. Participants who were randomly assigned to the music group listened via a portable cassette player with earphones for 30 minutes duration to music in the mid afternoon of posto perative day one. (This was the standard postop erative protocol time in the intensive care unit (ICU) setting for all patients to rest in bed). The self selected music was from the 0 musical pieces which contained a variety of different types of music i ncluding Turkish classic music, Turkish folk music, and Turkish art music. Fifteen minutes prior to the scheduled bed rest time on postoperative day one, the investigators gathered demographic and physiological data, and asked participants to rate their pain using a verbal descriptor pain intensity scale. Physiological parameters were recorded and pain intensity was rated immediately after 30 minutes of music was completed with experimental group participants and after 30 minutes of scheduled bed rest wi th control group participants. Results of this study indicated that there was a s ignificant difference between the mean pain intensity ratings of music group participants after the music therapy and the mean pain intensity ratings of control group partic ipants afte r the bed rest period (p= .000), but there was no difference between the group means pain intensity ratings at pre test. There were no significant differences between post test mean s for systolic blood pressure (SBP), diastolic blood pressure ( DBP), heart rate (HR), oxygen saturation (Sp02), and respiratory rate (RR) physiological parameters for music group and control group participants However, when examini ng within group differences,

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43 in vestigators found that after music therapy, comparing pre & pos t test scores, there w as a significant decrease in mean pain intensity ratings of musi c group participants (p=.000). With regard to p hysiological parameters, findings indicated that music therapy resulted in an increase in the mean Sp02 (partia l pressure of oxygen saturation) score of music group participants (p=0.00) No significant differences were found between the groups for the other four physiological parameters (SBP, DBP, HR, & RR). In the control group, no signif icant differences were found on any of the physiological parameters The investigators concluded that listenin g to music after surgery did reduce postoperative pain with patients who had undergone open heart surgery. Ozer and colleagues (2013) concluded that their findings were consistent with other studies that examined the effects of music on postoperative pain with patients who had undergone cardiac surgery In another study involving cardiovascular surgery patients, Jose and colleagues (2012) examined the eff ect of music therapy on pain perception and physiological parameters of blood pressure and pulse rate in patients who had undergone surgery and were being treated on the postoperative ward in the Cardiothoracic Vascular Surgery Department of a hospital in New Delhi. Their pretest post test experimental design study was conducted with a convenience sample of 60 adult subjects, with patients randomly assigned to receive music therapy (n=30) (treatment group) or rest (n=30) (control group). Treatment group p a rticipants rec eived music therapy which included listening to o ld Hindi songs de votional songs and i nstrumental songs. These s tudy participants were instructed to listen to music provided via a MP3 (digital audio)

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44 player with headphone s for a duration o f 20 minutes. ( The investigators did not specify whether participants were allowed to choose the type of music they would listen to, and they did not indicate what day or time after surgery the music listening occurred with treatment group participants ) Pre test pain perception was measured with treatment and control group participants using a numerical rating scale. (The investigators did not define or describe pain perception in their study). Pre test blood pressure and pulse rate were assessed with p articipants in both groups. T reatment group participants were instructed to listen to music for a duration of 20 minutes, and then they were asked to rest for 10 minutes. Participants in the control g roup were asked to rest for a duration of 30 minutes. Post test pain perception, blood pressure, and pulse rate were assessed with participants in both groups. Results of this study indicated that treatment and control groups were homogeneous with regard to pain and physiological parameters of blood pressu re and pulse rate. Importantly, the se investigators found there were significant decrease s in mean post test scores of music group participa nts with regard to pain ( p<0.05), syst olic (p<0.05) and diastolic ( p<0.05) blood p ressure, and pulse rate (p< 0.05). Further, they found significant difference s between treatment and control groups with regard to mean post test scores for pai n (p<0.05), systolic (p<0.05) and diastolic ( p<0.05) blood p ressure, and pulse rate ( p<0.05). In addition, treatment grou p participants who listened to m usic reported music had helped reduce their pain, had a soothing effect, and effected their mood in a positive way (from unpleasant to pleasant). Interestingly, after interviewing staff nurses and doctors at the study hospi tal about their attitude towards using music therapy as a pain management strategy, the investigators reported

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45 80% of doctors and nurses had moderately favorable attitudes and only 20% of doctors and nurses had highly favorable attitudes. The investigato rs concluded that in their study, music therapy was effective in reducing pain perception scores and had positive effects on the physiological parameters (b lood pressure and pulse rate) with patients who had undergone cardiac surgery. In another study wi th cardiovascular surgery patients, Cutshall and colleagues (2011) examined the efficacy and feasibility of ambient music with nature sounds on postoperative pain and anxiety. The study sample consisted of 100 adult participants (n=49 in the music group; n=51 in the control group). Participants were randomized to treatment groups in the following manner: at the start of postoperative day 2, participant pain levels were assessed on a scale from 0 (no pain) to 10 (the most intense pain). Randomization w or greater than 4 ( pain levels of 5 to 10) The randomization was blocked to ensure balanced allocation throughout the course of the study. A stratified randomized experimental des ign was used to assign patients to standard postoperative care in combination w ith ambient music sessions ( music group) or to standard postoperative care in combination with matc hed quiet resting sessions ( control group). On the morning of postoperative day 2, pain, anxiety, overall satisfaction with the study intervention (not defined further in the study), and relaxation were measured with visual analog scales (VAS), and physiological parameters of blood pressure and heart rate were assessed with all st udy participants. Participants in the music group were given a choice of one of four compact discs consisting of ambient music with nature sounds, and using CD (compact disc) players in the privacy of their rooms, listened to the music

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46 for 20 minutes du ration twice daily, in the morning and afternoon of postoperative days 2, 3, and 4. After 20 minutes of music therapy, measurements were repeated for pain, anxiety, relaxation, overall satisfaction before and after with the study intervention In additi on, blood pressure and heart rate were measured at this time Data were collected on age, sex, surgical procedure, and total daily dosage of opioids administered over the 3 day period for both music and control groups. Participants assigned to the contro l group were encouraged to rest in bed for 20 minutes duration twice daily in the mornings and afternoons of postoperative days 2, 3, and 4. Pain, anxiety, relaxation, blood pressure, and heart rate were collected before and after rest periods with contro l group participants. Results of this study indicated a significant decrease in mean pain scores in the afternoon session on postoperative day 2 only for music group p articipants when compared to control group participants mean pain scores (p=.001). Re sults indicated mean relaxation scores improved in the morning session of postoperative day 2 for music group participants compared to control group participants mean relaxation scores (p=.03). Besides these differences, results indicated no significant d ifferences between mus ic group participants and control group participants mean anxiety levels or satisfaction overall with the music intervention analgesic usage during their hospital stay results indicated no significant d ifferences between group participants These investigators concluded that mixed results in their study were consistent with other studies which examined the effects of music listening with hospitalized patients. They recommended that interventions such as ambient music should be

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47 considered as an adjuvant for more complete relief of postoperative pain with cardiac surgery patients (Cutshall et al., 2011). Neurosurgery S tud ies Mondanaro and colleagues (2017) conducted a mixed methods study examin ing the effects of music therapy interventions on the recovery of patients after spinal surgery. The ir study combined standard medical approaches and integrative music therapy. Sixty patients (35 female, 25 male) ranging in age from 40 55 years undergoing ante rior, posterior, or anterior posterior spinal fusion were randomly assigned to music therapy plus standard care (medical and nursing care with scheduled pharmacologic pain intervention) or standard care only. Patients in the experimental group received o ne 30 minute music therapy session during an 8 hour period within 72 hours of surgery. Music therapy involved the use of patient preferred live music that supported tension release/relaxation through incentive based clinical improvisation, singing, and/or rhythmic drumming or through active visualization supported by live music that encompassed tension resolution. The live music intervention was provided by a licensed music therapist, and individualized to preferences of study participants. At the end o f the live music experience, participants were asked to share with the music therapist their thoughts, impressions, or issues that contributed to their perceptions of their surgical outcome. The investigators failed to describe, short of not receiving the live music intervention, what was done wi th control group participants who received only standard care. M easurements in both groups were completed before and after the music intervention and included pain ratings using a visual analog scale (primary outco me measure), and anxiety and depression ratings using the Hospital Anxiety and

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48 Depression Scale (HADS), fear of movement ratings using the Tampa Sca le for Kinesiophobia (TSK) (secondary outcome measures). Qualitative data from the post live music interven tion interview with music therapy participants were coded, and grouped into theme s that had been peer tested by members of the research team. Descriptive statistics were used to analyze demographic data, and quantitative data, specifically the outcome mea sures, were analyzed using parametric (repeated measures analysis of variance) statistics. Results from their study indicated control and music therapy group participants reported significant ly d ifferen t pa in ratings (measured by visual analog scale) befo re and after music intervention (p=.01). C ontrol and music group participants did n ot differ in scores on the Hospital Anxiety and Depression Scale (HADS) anxiety (p = 0 .62) and depression (p=0 .85) or on the Tampa Scale for Kinesiophobia (p= 0 .93) Perce ptions of surgical outcome belief and hope in returning to original baseline of functionality; (2) indifferent: neither hopeful nor cynical about results of surgery; and (3) pessimistic: belief that nothing will restore the quality of life that existed before the spinal condition. These investigators concluded that music therapy, specifically patient preferred live music, offered within a therapeutic relationship (a licensed music therapist) favorably affected pain perception in patients recovering from spinal surgery. (M ondanaro et al., 2017). They recommended hospitals look into developing structured postoperative music the rapy program s to benefit postoperative patients exp eriencing pain.

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49 Lin and colleagues (2011) examined the effects of music therapy on anxiety, postoperative pain, and physiological reactions to emotional and physical distress in patients undergoing spinal surgery. The study was conducted using a quasi e xperimental pretest and posttest design with a sample of 60 adult s ubjects who were assigned to the study group (n=30) or control group (n=30) depending on the day of their surgery. Participants in the music group selected their favorite music from prep ared music offerings from the investigators. These music offerings included pop music, classical music, sounds found in nature, and sacred music, all soft melodies in o thei r music selection via a MP3 (digital audio) player for 30 minutes duration the evening before surgery, 1 hour before surgery, and in the mid afternoon on the first and second day after surgery. In addition, participants w ere encouraged to listen to musi c at any other times they desired. Measurement s of levels of pain intensity and anxiety using a visual analogue scale (VAS) and measurement s of the physiological parameters pulse rate and blood pressure we re recorded before and after scheduled music listening times. On the evening before surgery and on the second day after surgery, state anxiety was measured using the Sta te Trait Anxiety Inventory. I n addition for 24 hour analysis before surg ery and each post operative morning at 7:00 A.M. until the third day after surgery to test for cortisol, norepinephrine, and epi nephrine concentrations in urine. (The investigators indicated that cortisol excret i on in 24 hour urine samples have correlate d reliably with sec retion of hormones from the adrenal gland in response to physiological and emotional stress

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50 such as surgery ) P articipants in the control group did not listen to music but rather rested in bed for 30 minutes before measurements of pain and anxiety were ta ken. I nvestigators found significant differences in VAS mean anxiety scores between music group participants and control group participants at each time measurement (p=0.018 0.001). They also found significant differences in VAS mean pain scores between music group participants and control group participants at each time measurement ( p=0.001). I nvestigators did not find any sig nificant differences between music and control group parti levels of cortisol in urine samples measured The investiga tors concluded that r esults of their study indicated patients undergoing spinal surgery would benefit from receiving music therapy in the preoperative period and early postoperative period (that is, evening before and morning of surgery, day s 1 and 2 posto peratively) Their results suggested that the provision of self selected music enhanced the well being of surgical patients during the early postoperative period (Lin et al., 2011). Abdominal (GI, Renal) Surgery S tudies Vaajoki and colleagues (2012 ) e xamined the effectiveness of audiotaped music listening on pain intensity and pain distress with a convenience sample of 166 subjects who had undergone major abdominal surgery. Participants were assigned to experimental (n=83) and control (n=83) groups ba sed on using an alternate week of surgery arrangement until each group had the requisite number of participants. The study design was a quasi experimental, repeated measures, pretest posttest design. The music listening intervention used in this study choice of favorite music from a selection of the most popular and classic music in their

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51 included domestic and foreign hit songs. Mu sic listening via a MP3 (digital audio) player with headphones 30 minutes duration was offered to experimental group participants seven times during the postoperative period: the evening of surgery, morning, noon, and evening on the first and second pos toperative days. O n the third postoperative day, music was not played but measures were taken once to evaluate the long term effects of music listening with experimental group participants Control group participants did not listen to music but rather h ad a 30 minut e break between pre and post test measurements. Participants in both groups had 15 assessments: seven times before and seven times after the music listening intervention or break, and once during a follow up visit on the third postoperative day. In this study, seven main outcome meas ures were employed: pain intensity and pain distress measured with Visual Analog Scales (VAS) as well as numeric rati ng scales (NRS), blood pressure, heart rate, and respiratory rate The amount of analgesia used and its adverse effects during the first 72 hours after surgery, the duration of epidural pain management, and length of hosp ital stay were also measured for study participants. The investigators found that experimental group participants who receive d standard care and listened to music after surgery reported significantly lower pain intensity on postoperative day two (measured in the morning, at noon, and in the evening) compared with control group partic ipants at bed rest (p=. 0.02), during deep breathing (p=0.03), and in shifting position in bed (p=0.02). They also found that these experimental participants reported significantly less pain distress on postoperative day two (measured in the morning, at noon, and in the evening) compar ed with control

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52 group participants at bed rest (p=0.01), during deep breathing (p=0.04) and in shifting position (p=0.04). However, there were no significant differences in reported pain inte nsity and pain distress between experimental and control group p articipants on postoperative day one (measured in the morning, at noon, and in the evening). O n the third postoperative day there were no significant differences between experimental and control group participants on levels of pai n intensity and pain dist ress at bed rest, during deep breathing, and when shifting position in bed. Lastly, there were no significant differences in analgesic usage, adverse effects of analgesics, and length of hospital stay between experimental and control group participants. The investig ators concluded that their study results supported earlier findings which indicated that music listening can be a beneficial adjuvant to other non pharmacological and pharmacological pain relief methods for surgical patients (Vaajoki et al., 2 011). In another study of abdominal surgery patients, Good and colleagues (2010) compared the effectiveness of three different combinations of non pharmacological pain treatment: preoperative patient teaching for pain management (PT), audiotaped jaw relax ation technique and music (RM), and a combination of audiotaped patient teaching and jaw relaxation and music (PTRM) Preoperative patient teaching for pain management (PT) was defined as information taught to patients to empower them by increasing their knowledge and self efficacy for engaging in general postoperative care activities including use of patient controlled analgesia. Relaxation and music (RM) consisted of a jaw relaxation technique with a choice of sedat ive music in the background. Soft mu sic, without lyrics and relaxing and sedative in nature, was chosen

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53 by participants from the following types: synthesizer, harp, and piano and orchestra slow j azz, and inspirational music. The music was provided via a tape recorder and a remote control All interventions were introduced before surgery. The study sample consisted of 517 adult subjects who had undergone major abdominal surgery and received patient controlled analgesia. A 2 x 2 factorial design was used to assess the effects of PT versu sampling was used to increase the numbers of men, Blacks, and persons with intestinal and urological surgeries to improve the generalizability of study findings. Participants were assigned ran domly via minimization to four groups: PT, RM, combination of the two (PTRM), and control (no intervention). Minimization, (via a computer program; Zeller, Good, Anderson, & Zeller, 1997) was designed to balance groups according to gender, type of surge ry, chronic pain, race, smoking, and alcohol use. E xperimental interventions were given in addition to standard care PCA with instruction and reinforcement to all study participants To sample effects at different regular time points during postoperative recovery, study measurements were scheduled in the morning s and afternoon s of the first two days after surgery. Pain was measured using the Sensation and Distress Visual Analog Scales (VAS). Each scale consisted of a 100 millimeter horizontal line with verbal anchors of no sensation and most sensation and no distress and most distress. In this study, the t wo groups of participants who received relaxation and music (RM and PTRM) reported significantly less posttest pain on postoperative day 1 A M, PM, and postoperative day 2 AM compared to participants who did not use RM (PT and con trols). Also, there were no significant effects on opioid intake in the PT or RM

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54 groups on postoperative days 1 and 2. These investigators concluded that patient te aching (PT) alone did not reduce pain but that relaxation and music therapy were effective non pharmacological adjuvants to provide postoperative pain relief for abdominal surgical patients. Orthopedic S urgery S tudies Chen and colleagues (2015) exam ined the effects of listening to music on psychophysiological parameters (blood pressure, heart rate, and respiratory rate) during preoperative and postoperative days and looked to determine whether it could lower postoperative pain intensity and opioid d osage in patients who had undergone total knee replacement surgery. A two group repeated measures design was used with 30 subjects, ages 53 85 years scheduled for total knee replacement surgery Participants were randomly assigned to music group or cont rol group. Psychophysiological in room hospital monitors. A visual analog scale was used with participants to report postoperative pain. Opioid analgesic dosage was recorded cord, and converted to standardized units. Results of their study indicated no significant differences between music and control group blood pressure and heart rate measurements reported pai n intensity, or op ioid analgesic dosage. Respiratory rates while in the surgical waiting area (preoperative measurements) were lower for music group participants compared to control group participants (p=0.02). Within group comparison s showed systolic blood pressure mea surements of music group participants significantly and consistently dec reased during postoperative days (p=0.007).

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55 These investigators c oncluded listening to music after surgery could stabi lize systolic blood pressure in patients during postoperative recovery from total knee replacement surgery However, the effects of music on psychophysiological parameters ( diastolic blood pressure, heart rate and respiratory rate), and on pain intensity and opioid analgesic dosage after surgery require d further research. Ignacio and colleagues (2012) compared the effects of music versus no music on postoperative pain, state anxiety, and analgesic usage with a convenience sample of 21 subjects who had u ndergone elective orthopedic surgery (spina l, hip or knee arthroplasty). Using an experimental design, participants were randomized to music (n=12) an d non music (n=9) groups. Outcome measures in the study were pain (measured by a visual analog scale), state anxiety (measured by the State Trait Anxiety Inventory), and analgesic usage (total amount of pain medications used on postoperat ive day 1 and day 2). In this study, t he music intervention was administered on postoperative day 1 an d day 2, but the time of day this intervention was carried out with study participants was not reported. Also, the type of music offered to participants was not reported. The duration of music listening was reported to be 30 minutes; however, how music was delivered to s tudy participants was not reported. The investigators indicated that because of the small sample size and unequal variances and abnormal distributions of normality in the outcome measures, non parametric tests were used for data analysis. Results of the ir study indicated no demographic characteristic differences between music and control group participants. On the outco me measure of state anxiety, inve stigators found no significant differences between music and control group

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56 participants on state anxiet y scores. Ho wever, there was a significant decrease in state anxiety scores found within the music group on postoperative day 2 (Z=2.04, p=0.041). Music did not significantly reduce reported pain levels with music group pa rticipants compared to control g roup participants on either postoperative day 1 or day 2 ; however, there were significant decreases in pain levels found within the music group on postoperative day 1 (Z=2.98, p=0,003) and day 2 (Z=2.80, p=0.005). N o significant differences were found be tween music and non usage on postoperative day 1 or day 2. The investigators reported that all music group participants indicated they were satisfied with the music provided, but less than half of participants listened to music beyond the study intervention time. The investigators concluded their mixed findings for the effect of music on anxiety and pain reduction for patients who have undergone orthopedic surgery were both consistent and inconsistent with recent studi es reported (Allred et al, 2010, Lin et al., 2011), and findings were primarily influenced by the small sample size in their study (Ignacio et al., 2012). In another study of orthopedic surgery patients, Allred, Byers, and Sole (2010 ) examined the effect of listening to music on postoperative anxiety and pain as well as its effect on mean arterial blood pressure, heart rate, respiratory rate, and oxygen saturation with patients who had undergone total knee arthroplasty orthopedic surgery. The s tudy sample consisted of 56 adult subjects (n=28 experimental group; n=28 comparative rest group) with a mean age of 63.9 years, and 44.6% were men and 55.4% were female. Randomization into either the experimental group or the comparative rest group was d etermined by a sealed envelope system. An experimental

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57 design was used to examine the effects of music and/or quiet rest period on postoperative pain, anxiety, and physiological parameters measured on postoperative day 1. The music intervention consisted of listening with headphones to a compact disc of participant selected easy listening music choices provided by the investigators. These music choices were six different Compass Production Compact Disc Se lections TM Participants in the experimental group listened to their music selection for 20 minutes duration before their first ambulation effort postoperatively with the Physical Therapist, and listened again for 20 minutes duration during the rest period after their ambulation effo rt. Participants in the comparative rest group did not listen to music before their first ambulation effort and instead rested quietly for a 20 minute period a fter their ambulation effort. Data collection was carried out on postoperative day 1 and began 20 minutes before the first physical therapy session for all p articipants. Instruments used included the McGill Pain Questionnaire Short Form (MPQ SF), participant reported pain and anxiety measured using visual analog scales (VAS), and physiological me asurements of heart rate, blood pressure, respiratory rate, and oxygen saturation. Data collection occurred at four points: 20 minutes before first physical therapy (PT) session (T1), just before PT (T2), immediately after PT (T3), and 20 minutes after P T (T4). The amount of opioid used from the initiation of the music intervention to 6 hours later was r ecorded by the investigators. R esults indicated th at group par ticipants reported significantly different pain scores as measured with the VAS over time ( F = 6.713; p=.001). Also, post hoc pairwise comparisons found significant differences in participant reported pain (using the MPQ SF) between T1 and T2 (p=.000) and between T2 and T3 (p=.000).

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58 Interestingly, no significant differences in participant reported pain scores measured with VAS were found between the two groups at any measurement point (F=1.120; p=.337). With regard to music and anxiety, the results indicated that within group part icipants reported significantly different anxiety scores ove r time (F=4.124; p=.011). Also, post hoc pairwise comparisons found significant differences in participant reported anxiety between T1 and T2 (p=.035) and between T2 and T3 (p=.014). Interestingly, no significant differences in participant reported anxie ty scores were found between the two groups at any measurement point (F=1.566; p=.206). With regard to music and physiological parameters, the results indicated that participants in both groups had significant decreases in mean arterial blood pressure ( MAP) over time (F=9.891; p=.000). Howe ver, there were no significant differences in MAP between participants in the two groups (F=.388; p=.658). A lso, there were no significant differences in heart rate, respiratory rate, or oxygen saturation across time within groups, and similarly, no significant differences found in all of these parameters between groups at any study measurement time s I nvestigators reported that all study participants received patient controlled analgesia (PCA) at equivalent doses an d all participants had their PCA medications were available to participants within 6 hours of the study intervention. The re were no significant differences between partic ipant groups regarding oral analgesic intake. In interpreting their study findings the investigators noted that in previously published studies which reported music to be effective in reducing anxiety and pain with surgical patients, the studies did not examine the effect of music just before and just

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59 after a known painful experience that is, first ambulation effort after knee joint replacement surgery. They indicated that this difference ma y account for the study findings. Another reason offered by the investigators to explain the possible lack of significance in their study was in their study, t he quiet rest period used in their study could have act ed as an intervention itself, therefore the comparative rest group did not truly act as a control grou p but acted instead as a second intervention group. The investigators concluded that the results of their study provide evidence to suggest that in conjunction with traditional pharmacological interventions, pain and anxiety can be reduced while listenin g to music or when having a rest period just before and just after first ambulation effort after total knee replacement surgery (Allred et al., 2010). Transplant Surgery S tudy Madson and Silverman (2010) examined the immediate effect of music therapy on se lf reported measures of anxiety, relaxation, pain, and nausea levels with a sample of solid organ transplant patients. Both organ donor and transplant recipients, ranging in age from 18 70 years, comprised the study sample of 58 adult subjects who were of fered music therapy sessions. Organ transplant study participants experienced a range of pathologies including end stage renal disease, infection due to previous transplant, and multiple transplants such as pancreas and kidney. After meeting the required sample size, a ll patients on the hospital transplant unit were given the opportunity to receive music thera py. The study was a pretest posttest design without randomization of subjects or a control group. The investigators used participant self report r atings to measure the effects of music therapy on relaxation, anxiety, pain level, and nausea using four

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60 separate 10 point scales. Each representing a patient feeling completely relaxed, or free of anxiety, or experiencing no p ain, or experiencing no nausea and complete lack of relaxation, or high levels of anxiety, or high levels of pain, or high levels of nausea. The investigators commented that these measures and corresponding anchors wer e determined based on recommendations from the Head Nurse on the transplant unit and these measure s were measures Participants were asked to verbally report his or her levels of relaxation, anxiety, pain, and nausea before the music therapy session. The investigator then played patient preferred music while encouraging verbal interactions between songs. All music was played live on a guitar and sung by the principal investigator. The music therapy sessions lasted from 15 35 minutes in duration. Immediately after the music therapy session, the investigator asked participants to assess his/her levels of relaxation anxiety, pain, and nausea. It is noteworthy that mu sic therapy sessions were offered to all patients on the transplant unit on a weekly basis; h owever, only data from a single session of music therapy per participant were analyzed in the study Also no teworthy was that investigators failed to report in their study the postoperative day the music therapy session was analyzed for study participants. Results of this study indicat ed that there were significant differences in study participant reports for all four outcomes measured before and after the music therapy session with posttest mean scores improving for all evaluated self report variables: relaxation (p<.001), anxiety (p<.001), pain (p<.01), and nausea (p<.05). The investigators also looked to determine if the music therapy session positively affected

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61 partic ipants who reported high levels of pain (rating of 8 or higher on the Likert type pain scale) prior to th e music therapy intervention. They found that there were no significant differences b etween pre and post test pain scores of study participants who initially reported high levels of pain. The investigators concluded that music therapy was a viable intervention for postoperative transplant recipi ents and donors, and that their results we re congruent with other medical mu sic therapy literature which has shown music therapy to be effective in reducing anxiety, reducing levels of pain and nausea and increas ing relaxation with surgical patients (Madson & Silverman, 2010). Recent Systematic R eviews of Studies Examining Music Therapy In the past five years, five systematic reviews have been published by researchers who systematicall y reviewed studies examining music therapy as an adjuvant intervention for reducing postoperative pain with adult surgical patients. Findings from these recent systematic reviews will be synopsized below. Hole and colleagues (2015) conducted a systematic review and meta analysis to assess whether music improves recovery after surgical procedures. They included ran domized controlled trials (RCTs) of adult patients undergoing surgical procedures, excluding those involving the central nervous system or head and neck, published in any language. Surgical procedures of studies reviewed varied from minor endoscopic inter ventions to transplantation surgery. I ncluded were RCTs in which any form of music was proved, initiated before, during, or after surgery and compared these with standard care or other non drug interventions. The ir search included MEDLINE, Embase, CINAH L, an d the Cochrane Library In total t hey reviewed 73 RCTs with sample size s varying between 20 and 458 participants. Choice of mus ic, timing, and

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62 duration varied among the studies reviewed. Comparisons with music included routine care, headphones wit h no music, white noise, and undisturbed bedrest. In their review of 45 RCTs examining use of music after surgery, they found music reduced postoperative pain (SMD 0.77 {95% CI 0.99 to 0.56}), anxiety ( 0.68 { 0.95 to 0.41}), and analgesic use ( 0.37 { 0.54 to 0.20}), and increased patient satisfaction (1.09 {0.51 to 1.68}), but did not reduce length of stay in hospital for study participants (SMD 0.11 { 0.35 to 0.12}). Subgroup analyses showed that choice of music used and timing of delivery of music and type of control used made little diffe rence to study outcomes. They found no difference in pain reduction if measured between 0 to 4 hours after surgery and measured more than 4 hours before surgery. Pain seemed to be reduced most when music w as played preoperatively (SMD 1.28 { 2.03 to 0.54}), then intraoperatively (SMD 0.89 { 1.20 to 0.57}), and then postoperatively (SMD 0.71 { 1.03 to 0.39}). A similar pattern was noted with anxiety measures and analgesic usage among studies reviewed. These investigators concluded that sufficient research has been done to show that music should be offered to surgical patients as a way to help reduce pain and anxiety after surgery. They suggested that the timing and delivery of music as an interven tion could be adapted to clinical settings, medical teams, phases in the perioperative period, and individual patient care situations (Hole et al., 2015). In their literature review, Sin and Chow (2015) appraised current evidence from studies which examine d the use of music therapy and postoperative pain management among gyn ecological surgery patients, to determine the effect of music therapy for : (1) reducing postoperative pain intensity and consumption of analgesics; (2) minimizing the

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63 physiological symp toms of pain including but not limited to fatigue, nausea, and vomiting; and (3) minimizing an xiety level. The databases used to search for relevant studies included Medline, CINAHL, British Nursing Index, PsycINFO, and Allied and Complementary Medicine. Select ion criteria for studies in their review included those published 1995 to present, with adult female patients undergoing gynecological surgery, using music therapy as the intervention, with comparison group s without a music component, with outcomes measured including pain intensity, and experimental or quasi experimental design. The results of their review of 7 studies, found 5 of 7 studies indicated significant and positive effects of music therapy on the reduction of postoperative pain (p < .05 p < .001) ( Sample sizes for these five studies ranged from 73 to 311 p articipants ) Of the 7 studies included i n their review, 3 studies examin ed the effects of music therapy on pain related physiological outcome s including fatigue, nausea and vomiting, as well as anxiety level. One of these three studies found a significant effect for music therapy on reducing fatigue (p<.001) but no significant differences in the incidence of nausea and vomi ting compared to the control group (study sample size N = 90). The second of the three studies found no significant effect for music therapy on reducing the incidence of nausea and vomiting (study sample size N = 84). The third of these three studies found a signific ant effe ct for music therapy in reducing anxiety level after receiving the music intervention (p < .05 to P < .001) (study sample size N = 102). There was no evidence presented by these investigators as to the effect of music therapy on analgesic consumption from the 7 studies reviewed.

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64 T he se investigators concluded that findings from their review indicated music therapy appears to be effective in reducing pain intensity for patients undergoing gynecological surgery, but it had no impact on postoperative nausea and vomiting. They continued music therapy may be effective in minimizing fatigue and reducing anxiety with gynecological surgical patients. C epeda and colleagues (2013) conducted a systematic review of 51 randomized controlled studies that evaluat ed the effect of music on various types of pain in both children and adults. These studies included 1867 participants who had been exposed to music and 1796 control participants. In their review, they calculated the mean difference in pain intensity le vels, percentage of patients with at least 50% pain relief, and opioid requirements. To explore heterogeneity, studies that evaluated adults, children, acute, chronic, malignant, labor, procedural, or experimental pain were evaluated separately, as well a s those studies in which patients chose the type of music used. They found in 31 studies evaluating mean pain intensity as the outcome, there was considerable variation in the effect of music on pain intensity with subjects exposed to music. These studi es which permitted patients to select the music did not reveal significant benefits (such as postoperative pain reduction) from music. However, they did find in 4 studies evaluating mean pain intensity as the outcome, subjects exposed to music had a 70% higher likelihood of having significant pain reduction than subjects not exposed to music. They found in 3 studies evaluating opioid requirements two hours after surgery as the outcome, subjects exposed to music required significant ly less morphine than subjects not exposed to music. They found in 5 studies evaluating

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65 morphine requirements 24 hours after surgery as the outcome, subjects exposed to music required significant ly less morphine than subjects not exposed to music. These authors concluded t hat among the studies reviewed, the majority of studies did not report a significant effect on pain intensity reduction for subjects exposed to music. However, exposure to music did reduce pain intensity levels and opioid requirements among some study sub jects, but the magnitude of these benefits were small and therefore they felt the clinical importance of music exposure with surgical patients was unclear (Cepeda et al., 2013). Matsota and colleagues (2013) conducted a comprehensive systematic review of 4 1 studies including 7,617 participants in which the effect of music on perioperative stress and anxiety, perception of pain during procedures, postoperative pain intensity and analgesic requirements, and treatment of chronic pain were examined. Inclusion criteria in their review were randomized controlled trials, meta analyses, reviews, and controlled clinical trials written in English, included on PubMed during the last 20 years, and based on holistic care with surgery. The authors reported on 4 controll ed studies and 1 randomized clinical trial which examined the use of music or its combination with relaxation or therapeutic suggestions to reduce acute surgical pain in the immediate postoperative period (post anesthetic care unit PACU) and in the early postoperative period. They indicated the presence of supportive data in these studies (reducing pain, anxiety, discomfort), describing study evidence as positive (p=0.001 0.05), and suggested that music can serve as a complementary method for treating per ioperative stress and acute pain (Matsota et al., 2013).

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66 In a systematic literature search performed on Medline, Embase, CINAHL, and pain, Economidou and colleagu es (2012) found six randomized controlled trials that included 866 participants who had undergone elective surgery (varicose vein, inguinal hernia repair, abdominal hysterectomy, major abdominal, orthopedic, and gynecologic). These studies examined the postoperative analgesic usage. The authors found that these studies reported music significantly reduced postoperative pain among adult surgical patient group participants. They found evidence i n only one study with patients who had undergone open hernia repair as day care surgery indicating that participants who listened to music intraoperatively and in the post anesthetic care unit (PACU) required significantly less morphine in these settings c ompared with the control group participants (p value <0.05) (Economidou et al., 2012). Summary of Review of Recent Literature Examining Music Therapy There is considerable evidence from recently published studies as well as recently published systematic reviews to indicate that music therapy, used as adjuvant therapy along with anal gesic medication s is effective in reducing postoperative pain and in so me instances, effective in reducing opioid analgesic usage among surgical patients. It is noteworthy that among these studies, besides differences in study methodologies, types of surgical patients sampled, and outcomes measured, there were between s tudy differences in type s of music in tervention used, duration of the music intervention, timing of administering the music intervention, frequency of use of the m usic intervention, and results music interve ntion in reducing postoperative pain. Also noteworthy is some studies had

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67 methodological limitations due to inadequate sample size s lack of random assignment to treatment and control group s no assurance of pretest equivalence on the dependent variable(s) measured delayed posttest measurement of the dependent variable(s), and lack of control for analgesics taken at time of testing, all factors which may reduc e the validity of study conclusions. Indications for this Study T he studies reviewed above examined the effect of music therapy on postoperative pain with surgical patients looking a t, for the most part, the outcome of postoperative pain reduction while patients were recovering in hospital from surgery N one of these stu dies examined the effect of music therapy on postoperative pain with surgical patients after discharge from hospital. Acute surgical pain after joint replacement surgery persists beyond discharge from hospita l gene rally lasts for several days, and worsen s for patients during postoperative mobilization (Harlocker, 2010). Unrelieved pain can impede effective physical therapy which is important if the patient is to regain good range of motion and optimize their surgical outcome ( Labraca et al., 2011) Ther efore, patients who have undergone joint replacement surgery need to optimally control their pain after surgery in order to maximize their surgical outcome, and prevent complications after surgery A fter discharge from hospital, orthopedic patients need to have available to them strategies to use along with prescribed analgesic medications, to help reduce their pain. In this study this investigator examined the use of a music intervention for reducing postoperative pain with patients who had undergone o rthopedic joint arthroplasty surgery The study intervention was used by music group participants both in hospital and after discharge from hospital. It was anticipated that results from this

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68 study would direct nurses to recommend music as an adjuvant a long with prescribed analgesic medications, for use in hospital and after discharge with patients who had undergone orthopedic joint arthroplasty surgery An adjuvant therapy like music can help patients manage acute pain after surgery facilitate mobili zation after surgery, th erefore optimizing their clinical outcome from surgery. I n addition in this study t he investigator examine d the usefulness of G nursing pain management theory for guiding this research and pain management practice s

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69 CHAPTER 3 METHODS An experimental design is the appropriate research strategy to use when the question to be answered requires the testing of theory or causal relati onships (Polit & Be ck, 2008). The major strength of this design lies in its ability to control variance and to take into account factors that may contribute to differences in the dependent v ariable (Polit & Beck, 2008). I n this study, the inv estigator used a prospective ra ndomized trial to exam ine the relationships among study variables. Sample and Setting A convenience sample of ort hopedic surgery patients were recruited to participate from the target population of surgical patients for this study. Use of a nonprobabilit y sample limits the generalization of study findings to the sample; however, in light of the inherent difficulties in accessing this population, this sampling technique is justified (Polit & Beck, 2008). Because pain character and intensity may vary by lo cation and extens iveness of the surgery, only two type s of surgical patient group s were eligible to participate in order to maintain homogeneity of the study sample : patients who had undergone knee joint arthroplasty surgery, and patients who had undergon e hip joint arthroplasty surgery. A sample size of 50 participants was used in this study in order to meet the requirements for statistical analysis and to account for losses due to attrition (Cohen, 1988). This sample size was determined based on a pow er analysis for the covariance using a large effect size (d=.80) power of 0. 8 0 and alpha = 0.05 (Coh en, 1988). Participants were randomly assigned to treatment and control groups using the coin toss method This provide d some degree of certainty that pa rticipant characteristics

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70 ( e.g. biological, psychological, and sociocultural characteristics) which could influenc e the dependent variable were evenly distributed between the two groups (Polit & Beck, 2008). The sampling frame include d every eligible patient listed for elective knee or hip joint replacement surgery in a major university affiliated teaching hospital in the southeastern United States during a 5 month period (specifically, UF Health Gai nesville, FL). Patients were i denti fied by the ort hopedic surgeon at preoperative visits, and eligibility fo r inclusion in the study was determined in consultation with the investigator Potential study subjects were initially approached by the orthopedic surgeon to obtain agreement to me e t with the investigator at the preoperative office visit. During this selection process, patient privacy was maintained in accordance with US government mandated HIPA A regulations. Consent to participant in the study was obtained from patients who agree d to participate in the study at the preoperative office visit after they received an explanation of t he study from the investigator. Inclusion C r iteria Criteria fo r inclusion in the study were : 1) male and female patients, ages 35 to 100 years; 2) sch eduled for elective orthopedic knee or hip joint arthroplasty surgery (total, partial arthroplasty or revision surgery); 3) oriented to person, place, time, and conversation; 4) anticipated receiving nerve block for pain relief postoperatively, 5) anticip ated hospitalization of tw o or more days postoperatively; and 6) had access to an internet enabled device such as a smartphone or tablet that can access on line radio music like Pandora.

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71 Exclusion C riteria Criteria for exclusion in the study were : 1) hav ing verbal, visual auditory or psychomotor study ( for example, ina bility to communicate verbally with study staff visual impairments not allowing the patient to view s tudy measurement instruments and use the music listening device, auditory impairments not allowing the patient to use a device for music listening or psychomotor impairments not allowing the patient to write data collection information in log booklets or use a device to listen to music ); 2) hav ing cognitive or affective impairments that impede their ability to participate in the study ( e.g. severe anxiety, severe depression, or thought processing disorders requiring hospitalization within the past year); 3) hav ing a postoperative stay in any intensive care unit (ICU) or step down unit because of a medical or surgical complication experienced during the perioperative period: and 4) non English speaking patients because study measurement instruments and ver bal instructions for u se of the music intervention were administered in English. Measures Demographic C haracteristics All participants w ere asked to provide demographic data such as age, gender, marital status, race, educational level, and number of concu rrent conditions causing pain w ere recorded by the investigator on a standard form. These variables were used as descriptive variables in the study. Pain : Intensity and D istress In order to measure the total pain expe rience, instruments use d in this stu dy assess ed both the sensory and emotional components of pain. A numeric rating sca le

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72 (NRS) was used in this study to measure the sensory compone nt of pain: pain intensity. Th is i s a ten centimeter rating scale anchored by no pain (0) at one end and 10 ( most pain imaginable ) at the other end with numbers 2 thru 9 at 1 centimeter increments. S tudy participants were asked to use this scale to rate pain intensity as it was consistent with what was used in the clinical agency. Support for use of the NRS to measure pain intensity is found in recent research indicating that single item scales are psychometrically acceptable measures of global pain ratings (McCarthy, et al., 2005). The Distress Scale (Johnson, 1973), a descriptive rating scale which includes words describing the degree of distress exp erienced from pain, was ad a pted for use in this study to measure the emotional component of pain. Validity of this scale was supported by Johnson (1973) who found that participants could differentiate between pain intensity and distress during induced ischemic pa in. The Distress Scale is wide ly used in clinical research with a variety of patient groups and found to be a valid, reliable, and sensitive measure of pain (Good et al., 2001). A numeric rating sc ale ( NR S) was used to measure pain distress, anchored by no (0) at one end an d 10 ( most distress imaginable ) at the other end with numbers 2 thru 9 at 1 centimeter increments. Because pain is a multidimensional concept, it is reasonable to have used more than one measure to capture the pain experience (that is, pain intensity an d pain distress) of participants in the study. Pain (intensity and distress) was measured once the evening of surgery, at three time periods daily during postoperative days 1 and 2, and at three time periods daily the first two days post discharge from ho spital. Study participants were instructed to document all pain scores in a log booklet designated for use in hospital, and in another log booklet designated for use after discharge from hospital.

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73 Nausea and D rowsiness S ide effects from opioid analgesia admin istered postoperatively were measured in the st udy the evening of surgery, at three time periods daily on postoperative day s 1 and 2 and at three time periods daily the first two days post discharge from hospital, and include d the opioid side effects of nausea and drowsiness. The level of t hese side effects w ere measured using numerical rating scales ( NRS) with scores ranging in intensity from 0 to 10 imaginable. Study participants were asked to rate the se sid e effect s when ever rating pain intensity and pain distress, and to document these scores in a log booklet designated for use in hospital, and in another log booklet designated for use after discharge from hospital. State A nxiety Anxiety is a common reaction among patients to surgery. Anxiety is known to possible covariate. Sp ie lberger (1983) described state anxiety as existing in a transitor y emotional state that varies in intensity and fluctuates over time. This describes the type of anxiety expe rienced by surgical patients when measured at one time period during the postoperative course; therefore, in this study, state anxiety was measured using the State Trait Anxiety Inventory (STAI Form Y 1 ) (Sp ie lberger, 1983) This instrument includes 20 items, each with a scoring range of 1 to 4; the total possible score ranges from 20 80, with higher scores indicating higher levels of state anxiety. This instrument has been widely used with patients in clinical practice and research and has good reported reliability and validity (Sp ie lberger, 1983). State anxiety was measured at one time period the evening of surgery after pat ients had returned fr om surgery, and was

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74 measured in this study to determine its relationship to patient reports of pain intensity, pain distress, nausea, and drowsiness. Analgesic U sage Information regarding participant use of op ioid analgesics (drug types prescribed and us ed) on postoperative day s 1 and 2 were obtained fro record (EPIC) Consistent with standard practice an opioid equianalgesic chart was used to convert all opioid intake to milligrams of m orphine equivalency (Equivalent Opioid Calcu lator, ClinCalc.com) This calculator was chosen because the guidelines and critical review papers regarding equianalgesic dosing. Information regarding participant use of non opioid analgesia (drug type s prescribed and used ) on postoperative day s 1 and 2 were obtained from the hospital record Similarly, total non opioid analgesic usage was to be calculated by converting all non opioid doses received by the patie nt to acetaminophen equivalency. An equivalency calculator was not needed for acetaminophen equivalency as these determinations were not necessary because oral acetaminophen was the only non opioid drug received by study patients in hospital and prescribe d for postoperative pain relief after discharge from hospital. All study participants receive d pain medication as medically prescribed without influence from the investigator. Music Listening Experience after Surgery Survey Treatment group participants were asked to rate five statements, using a five captured their perception of their music listening experience after surgery. This survey

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75 ended with an open ended questi obtained from this survey was analyzed quantitatively. Overall Pain Experience in Hospital after Surgery Survey All study participants were asked to rate five statements, using a five point Likert scale ra perception of their overall pain experience in hospital after surgery. This survey ended with an open ended question asking for participant comments. Information from this s urvey was analyzed quantitatively. Table 3 1 summarizes the measures used in this study, organized in the order of their use in the study protocol: screening, postoperative days in hospital, and post discharge assessments. Table 3 2 summarizes the measur ement protocol during postoperative days in hospital and post discharge days. St udy Intervention: Music Listening and evidence based use of music interventions to accomplish indi vidualized goals within a therapeutic relationship by a credentialed professional who has completed an In this study, music as an intervention was offered by the study investigator, a licensed Registered Nurse w ho was not a credentialed professional from an approved music therapy program. However, the study investigator did consult with two credentialed professional s, the director and a residence/coordinator of the Center for Arts in Medicine Program affiliated with the clinical agency study site for input in implement ing music listening as the intervention for this study.

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76 When healthcare providers recommend a cogni tive behavioral modality for use with a patient to manage symptoms like postoperative pain, th e amount of energy the patient can put forth to effectively utilize the approach should be considered An approach recommended for use in c linical practice guidelines (AHCPR) to manage acute surgical pain with patients and chosen for use as the intervent ion in this study was music (Carr et al., 1992). This approach is simple easy for patients to lear n and feasible for use by patients in the postoperative clinical and home setting s Since nurse time busy surgical unit s this simple approach for pain management is reasonable for a surgical nurse to instruct and facilitate with patients on the surgical unit. In this study, study participants assigned to the treatment group were instructed to listen to music of their choice for 30 minutes duration, three times a day when they experienced pain. They were instructed to listen to music beginning the evening of surgery, and again on postoperative days 1 and 2 w h en in hospital. Once discharged from hospita l, treatment group participants were asked to continue listening to music three times a day the first two days post discharge from hospital. If treatment group participants listen ed to music more than the three times daily as instructed for the study, the y reported this to the investigator If control group participants listened to music during the study period, they were to report this to the investigator. Music listening was achieved by patients accessing internet radio music using a personal electroni c device such as an i phone or i pad brought by the patient to hospital and later used by the patient after discharge from hospital

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77 Procedure Preoperative Office V isit At the preoperative off ice visit located in the hospital affiliated orthopedic cli nic, potential study participants were identified initially by the orthopedic surgeon according to inclusion criteria. Potential participants were asked if they would be willing to meet with the study investigator to discuss the study. During the pre oper ative clinic appointment, the investigator met with potential participants to explain the study, determine interest in participating, and screen for exclusion criteria using a brief screening tool. Potential participants were read a list of six items inc luding sensory, mental, and emotional conditions, and asked if they currently experienced any of the were excluded from the study. If interested and eligible, inform ed written consent was reviewed with potential p articipants following an explanation of the study per the University of Florida Health Sciences Center Institutional Review Board (UF HSC IRB) protoc ol. Signed consent was obtained by the investigator one signed copy was given to the participant, and one signed copy was kept for A signed copy of the Informed Consent was scanned into the pa s electronic medical record (EPIC) The investigator randomly assign ed each p articipant to either the treatment or control group using the coin toss method Following this, a bri ef, structured interview was conducted to collect demographic data such as age, gender, marital status, race, educational level, and data regarding curren t pain conditions experienced. Contact information of personal phone number (cell or home) was obtained from study participants for the follow up telephone call placed to participants the third day post

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78 discharge from hospital. Participants were inf ormed that the investigator would meet up with them again the evening of the surgery to continue with the study. Evening of Surgery Hospital V isit Treatment group participants Treatment group participants met with the study investigator the evening of surgery when they returned to the surgical unit after surgery. The purpose of the study, the study protocol, and measurement instruments used were reviewed with participant s Pain intensity, pain distress, naus ea, and drowsiness were rated the evening of surgery, using numeric rating scales ( NR S), and participants were instructed on how to document these ratings in the Hospital Log Booklet (Music Group) Follo wing this, s tate anxiety was measured using the Stat e Trait An xiety Inventory (STAI Form Y 1). After taking these measurements, treatment group participants were instructed on how to access internet radio music, like Pandora, with their personal device brought with them to hospital They were instruct ed to listen to their chosen music selection for a duration of 3 0 minutes three times a day on postoperative days 1 and 2, including the evening of surgery. Before and after the music listening sessions, treatment group participants were instructed to rat e and document in their hospital booklet their pain intensity, pain distress, nausea, and drowsiness levels. The investigator g a ve them suggestions for listening to music in a relaxed manner, and suggested post ing a sign on Music listening in session do These signs had been created by the nursing staff on the surgical unit. T hey were asked to document any personal methods used for controlling pain during the music listening session s.

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79 In preparation for discharge from hospital, treatment group participants were instructed to continue music listening as they had in hospital, and to rate and document their pain intensity, pain distress, nausea, and drowsiness levels as they had in hospital for the first two days post discharge from hospital. They were given a Discharge Booklet (Music Group) to document their music listening sessions and variable ratings. In this booklet were two surveys that they were asked to complete after disc harge: 1) Music Listening Experience after Surgery Survey, and 2) Overall Pain Experience in Hospital after Surgery Survey. They were informed that per the study protocol, the investigator would conduct a follow up telephone call with them on the third da y discharged from hospital to discuss the music listening and variable ratings the first two days post discharge from hospital, and to review their responses to the two study surveys found in their Discharge Booklet. Participants were thanked for their pa rticipation in the study, and reminded to mail in the return self addressed stamped envelope their completed Discharge Booklet. Information regarding opioid and non opioid analgesia prescribed and used by treatment group participants the evening of surgery, and on postoperative day s 1 and 2 were gathered from the medication record ( EPIC ). Information regarding opioid and non opioid analgesia prescribed and taken by treatme nt group participants during the first two days post discharge from hospital were gathered from documentation in the Discharge Booklet (Music Group) and from participant reports during the telephone follow up call by the investigator the third day discharg ed from hospital.

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80 Control group participants Control group participants met with the study investigator the evening of surgery when they returned to the surgical unit after surgery. The purpose of the study, the study protocol, and measurement instruments used were reviewed with participants. Pain intensity, pain distress, nausea, and drowsiness were rated the evening of surgery, using numeric rating scales ( NR S), and participants were instructed on how to document these ratings in the Hospi tal Log Bookle t (Control Group) Following this, state anxiety was measured using the State Trait Anxiety Inventory (STAI Form Y 1). After taking these measurements, control group participants were instructed to rate their pain intensity, pain distress, nausea, and dro wsiness before and after scheduled mealtimes (that is, breakfast, lunch, and dinner) in hospital. These measurements reflected the frequency (three times per day) and duration (about 30 minutes) of the music listening sessions for treatment group particip ants. Th ey were asked to document any personal methods used for controlling pain during the ir hospital stay In preparation for discharge from hospital, control group participants were instructed to continue with mealtime ratings as they had in hospita l, and to rate and document their pain intensity, pain distress, nausea, and drowsiness levels for the first two days post discharge from hospital. They were given a Discharge Booklet (Control Group) to document their mealtime variable ratings. In this booklet was one survey they were asked to complete after discharge: 1) Overall Pain Experience in Hospital after Surgery Survey They were informed that per the study protocol, the investigator would conduct a follow up telephone call with them on the thi rd day discharged from hospital to discuss mealtime variable ratings the first two days post discharge from hospital, and to review their responses to the one study survey found in their Discharge Booklet

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81 (Control Group). Participants were thanked for the ir participation in the study, and reminded to mail in the return self addressed stamped envelope their completed Discharge Booklet (Control Group) to the study investigator. Information regarding opioid and non opioid analgesia prescribed and used by co ntrol group participants the evening of surgery, and on postoperative day s 1 and 2 ir electronic medication record ( EPIC ). Information regarding opioid and non opioid analgesia prescribed and taken by control group participants during the first two days post discharge from hospital were gathered from the documentation in the Discharge Booklet (Control Group) and from participant reports during the telephone follow up call by the investigator the third day discharged from hospital. P ostoperative Days 1 and 2 Visits or Phone Calls Treatment g roup Treatment group participants were either visited in hospital or received a telephone call from the investigator on postoperative days 1 a nd 2 to discuss their adherence to the study protocol, and an swer any questions that had arisen about the study. Participants were reminded about the need to continue the study protocol for the first and second day post discharge from hospital. They were reminded about the follow up telephone call they would receive from the study investigator on the third day post discharge from hospital. Also, they were reminded about the need to mail back to the study investigator via United States Postal Service (USP S) the Discharge Booklet (Music Group) in the self addressed stamped envelope provided to them the evening of surgery. They were informed to leave their completed Hospital Booklet (Music Group) with the registered nurse upon discharge from hospital. The study investigator made

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82 arrangements with the Nurse Manager on the surgical unit to collect these booklets from participants and keep them securely stored in her locked office until the next day the investigator arrived to the unit to retrieve participants Control g roup Control group participants were either visited in hospital or received a telephone call from the investigator on postoperative days 1 and 2 to discuss their adherence to the study protocol, and an swer any questions that h ad arisen about the study. Participants were reminded about the need to continue the study protocol for the first and second day post discharge from hospital. They were reminded about the follow up telephone call they would receive from the study investi gator on the third day post discharge from hospital. Also, they were reminded about the need to mail back to the study investigator via USPS t he Discharge Booklet (Control Group) in the self addressed stamped envelope provided to them the evening of surge ry. They were informed to leave their completed Hospital Booklet (Control Group) with the registered nurse upon discharge from hospital. The study investigator had made arrangements with the Nurse Manager on the surgical unit to collect these booklets fr om participants and keep them securely stored in her locked office until the next day the investigator Third Day Post Discharge from Hospital Follow Up Telephone Call Treatment g roup On the t hird day post discharge from hospital, treatment group participants received a follow up telephone call from the study investigator to review the information they had documented in their Discharge Booklet (Music Group) regarding music listening and variabl e ratings (pain intensity, pain distress, nausea, and drowsiness)

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83 during the first two days post discharge from hospital, and to review responses to the two study surveys found in their Discharge Booklet (Music Group): Music Listening Experience after Sur gery Survey, and Overall Pain Experience in Hospital after Surgery Survey. They were reminded about the need to mail back to the study investigator the Discharge Booklet (Music Group) in the self addressed stamped envelope provided to them in hospital. Th ey were informed that the study had concluded, and were thanked for their participation in the study. Control g roup On the third day post discharge from hospital, control group participants received a follow up telephone call from the study investigator to review the information they had documented in their Discharge Booklet ( Control Group) regarding mealtimes and variable ratings (pain intensity, pain distress, nausea, and drowsiness) during the first two days post discharge from hospital, and to review re sponses to the one study survey found in their Discharge Booklet ( Control Group): Overall Pain Experience in Hospital after Surgery Survey. They were reminded about the need to mail back to the study investigator the Discharge Booklet ( Control Group) in the self addressed stamped envelope provided to them in hospital. They were informed that the study had concluded, and were thanked for their participation in the study. Timeline for Contact with Study Participants There was a seven day timelin e for contact with study participants in hospital and post discharge from hospital from postoperatively the evening of surgery (contact #3) until the follow up telephone call the third day post discharge from hospital (contact #6). This timeline for cont act with study participants is shown in Figure 3 1.

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84 Data Analysis Statistical analysis were carried out in this study using the Statistical Package for the Social Sciences Software (SPSS, Version 24, Chicago IL). Both parametric an d non parametric tests were carried out to analyze study data Demographic d ata were analyzed using descriptive statistics to describe the sample characteristics and inferential statistics were used to compare treatment and control group means on study dependent variables C hi Square testing was used to determine if there were significant differences between treatment and control groups on following demographic variables : gender, marital status, race, educational level, and concurrent pain conditions and independent t test was carried out to report means, standard deviations, and percentages for the demographic variable of age by group. Descriptive statistics were computed to present means and standard deviations by group for the study variables of pain intensity, pain dis tress, and opioid side effects o f nausea and drowsiness. Descriptive statistics were computed to present frequencies of types of opioid and non opioid analgesics by group. D escriptive statistics for study dependent variables were computed for both in hospital and post discharge periods. State anxiety was examined in this study as a possible covariate. Correlations b etween evening of surgery level of state anxiety and evening of surgery levels of pain intensity, pain distress, nausea, and drowsiness were examined using Pearson correlation coefficient. Controlling for pre measure differences in pain intensity, pain distress, nausea, and drowsiness, Analysis of Covariance (ANCOVA) was used to compare differences between treatment group (music listening + analgesic medication s ) and control group (analgesic medication s only) adjusted means for pain intensity, pain distress, nausea, and drowsiness levels The significance level was set at 0.05 for the

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85 study. As a meth od of statistical control, use of ANCOVA is suggested in order to reduce the error term (the variance within groups) by separating out the variance resulting fro m co nfounding variables (pre measure study variable s ) (Polit, 2010; Zeller, Good, Anderson, & Z eller, 1997). ANCOVA testing comparing differences between was carried out for both in hospital and post discharge periods. In this study, mean differences between op ioid and non opioid analgesic usage between treatment and control group participants wa s examined using independent t T ests T T ests were carried out for both in hospital and post discharge analgesic usage. Descriptive statistics were used to a naly ze stud reported frequencies of response ratings to questions on the Music Listening Experience after Surgery Survey (completed by treatment group participants) and the Overall Pain Experience in Hospital after Surgery Survey (completed by treatment and control group participants). Institutional Rev iew Board Study Approval The University of Florida Health Sciences Center Institutional Review Board (UF HSC IRB 01) approved this study Study Enrollment and Data Diagram Enrollment of participants in this study is depicted in Figure 3 2. At the clinical agency study site, a total of 510 patients had undergone either knee or hip arthroplasty during the 5 month enrollment period January to May, 2017. During this period, a total of 205 patients had undergone arthroplasty surgery with one of the th ree participating orthopedic surgeons. From this 205 patient pool the investigator was able to screen 97 patients for potential enrollment in the study. Among those screened, 47 patients were

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86 excluded from the study because they either did not meet the inclusion criteria (n=28) or declined to participate in the study (n=19). R easons for exclusion from the study included not hav ing an internet access device to bring to hospital to listen to music (n=10), sensory deficits related to hearing or vision ( n=3 ), or alre ady listening to music for pain relief (n=2). When given, reasons for dec lining to participate in the study Therefore, a total of 50 patients agreed to participate in the study; 24 participants were randomly assigned to the treatment group (music listening + analgesic medications ) and 23 participants were assigned to the control group (analgesic medications only). After t he Preopera tive Clinic visit but before scheduled surgery 2 participants missed by the investigator; therefore 3 participants all from the control group did not follow through and complete the study. Study follow up post discharge from hospital yielded missing data for 6 participants in the music group, and 4 participants in the control group. These data were missing because participants could not be contacted by the investigator for their follow up telephone interview on discharge day 3, and because they did not return their Discharge Log Booklets with self reported data by USPS as requested. Further, 2 participants in the music group did not complete hospital assessments: one participant because of uncontrolled pain along with the need to remain in the post anesthetic care unit (PACU) due no hospital bed availability, and the second particip ant because he did not bring an internet access device to hospital to listen to music. Therefore, for the

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87 music group, 22 participants completed some hospital assessments, and 18 participants completed some post discharge assessments. In the control grou p, 23 participants completed some hospital assessments, and 19 participants completed some post discharge assessments.

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88 Table 3 1. Measurement Battery Construct Measure Demographics Age, sex, race, marital status, educational level # of concurrent pain condition(s) Pain: Intensity & Pain Distress Numeric Rating Scales (NRS) (0 10); self recorded in hospital & discharge booklets Analgesics: in hospital Medication administration info found in EPIC Analgesics: post discharge Self reported analgesic use; recorded in discharge booklets Opioid Side Effects: nausea & drowsiness Numeric Rating Scales (NRS) (0 10); self recorded in hospital & discharge booklets State Anxiety State Trait Anxiety Inventory ( STAI Form Y 1 ) Music Listening Experience after Surgery Survey 5 Likert like scale statements to rate perceptions of music listening experience Overall Pain Experience in Hospital a fter Surgery Survey 5 Likert like scale statements to rate perceptions of overall pain exper ience in hospital after surgery

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89 Table 3 2. Measurement Protocol Post operative (in hospital) Day Post discharge (from hospital) Day Group & Assessment D O S 1 2 1 2 3 Pain Intensity & Distress: Treatment (Music Listening) 3x/day: pre and post music listening analgesics taken self recorded in log s Pain Intensity & Distress Control (No Music Listening) 3x/day: pre and post meals analgesics taken self recorded in log s Analgesics: in hospital Both Groups as recorded by nursing staff in EPIC self recorded in log s Analgesics: post discharge Both Groups self recorded in log s Opioid Side Effects: Nausea & Drowsiness Both Groups self recorded in log s along with pain intensity/distress State Anxiety Both Groups Music Listening Experience After Surgery Survey* Treatment (Music) Group telephone interview Overall Pain Experience in Hospital after Surgery Survey* Both Groups telephone interview

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90 Figure 3 1. Timeline for Contact with Study Participants. Contact #1: Pre Op Clinic Visit Appt initial contact by Orthopedic Surgeon Contact #2: r Pre Op Clinic Visit Appt Investigator Screening /Consenting Meeting Contact #3: In Hospital DOS Music listening introduced here Contact #4: Phone call or visit in hospital POD1 Contact #5: Phone call or visit in hospital POD2 Contact #6: Discharge Follow Up Telephone Call Third Day Discharged from Hospital

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91 Figure 3 2. CONSORT Enrollment & Data Diagram

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92 CHAPTER 4 RESULTS The purpose of this study was to investigate the use of a music intervention as an ad juvant with prescribed analgesic medications to reduce postoperative pain with patients undergoing knee or hip joint arthroplasty surgery. This research study was a prospective randomized trial that evaluated the effectiveness of a combined interventio n (music plus analgesic medications ) in reducing pain and other related symptoms compared to a control group who received analgesic medications alone. The research questions were as follows: 1. What are the levels of pain intensity, pain distress, and op ioid side effects of nausea and drowsiness, state anxiety, and o pioid and non opioid analgesic usage among adult patients undergoing joint arthroplasty surgery the evening of surgery, during first two post operative days in hospital, an d the first two days post discharge from hospital? 2. In adults undergoing joint arthroplasty surge ry, is state anxiety associated with postoperative symptoms of pain (inten sity and distress), nausea, and drowsiness? 3. In adults undergoing joint arthroplasty surg ery, is a combined intervention (music listening plus analgesic medication s ) more effective th an analgesic medication s alone in reducing postoperative symptoms (pain intensity, pain distress, nausea, drowsiness ) the evening of surgery, during the first two postoperative days in hospital, and the first two days post discharge from hospital? 4. In adults undergoing joint arthroplasty surge ry, do participants who receive the combined intervention (music listening plus analgesic medication s ) use less opioid and n on opioid analgesics than those participants who do not receive the treatment intervention during the first two postoperative days in hospital and the first two days post discharge from hospital? 5. sic listening experience after s urgery (music group), and perceptions o f their overall pain experience in hospital after surgery (music and control groups)?

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93 Sample Characteristics The sample consisted of 50 participants 24 were randomly assigned to the treatment group and 26 to the control group. Demographic characteristic of the study sample are presented in Table 4 1. Using Chi Square and t tests, there were no significant differences between music group participants and control group participants on any of the demo graphic measures. Thus, demographic characteristics of the full sample are described. The mean age of study participants in th is sample was 66.64 years (R = 45 81 years SD = 8.711 ). The sample was approxi mately equal in terms of sex; 21 (42%) males, and 29 (58%) females. The majority of the sample was White (n=40, 80%), married (n=26, 52%), and had a high school education (n=45 90%). The majority of participants reported experiencing one concurrent pain condition (n=43, 86%), with 14% (n=7) patients experiencing 2 3 concurrent pain conditions. Forty seven participants completed the study. Of those completers, 3 0 participants (63%) had total knee arthroplasty surgery, and 1 7 (36%) had undergone total hip joint arthroplasty surgery. The majo rity of procedures were primary joint arthroplasty surgeries (n=37, 79%) and 10 (21%) were revisions of previous arthroplasty surgeries. M ain Study Results In the following section analysis of each research question will be presented. The results are or ganized and presented separately for hospital a nd post discharge from hospital. Descriptive Analysis of Main Study Variables Question 1. What are the levels of pain intensity, pain distress, opioid side effects of nausea and drowsiness, and opioid and non opioid analgesic usage among a dult patients who had undergone joint arthroplasty surgery the evening of surgery

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94 during the first two postoperat ive days in hospital, and during the first two days post discharge from hospital? Hospital Pain (intensity and distress) and opioid analgesic side effects (nausea and drowsiness), w ere assessed the evening of the day of surgery, three times per day on postoperative days one and two in hospital. Descriptive results for these variables are presented separate ly for e ach symptom. See Table 4 2 through Table 4 5 for summary of means. In addition, data on analgesic medication use in hospital is presented in Table 4 6. The descriptive results indicate that participants in this study reported experiencing moderate pain immediately after surgery, and mild symptoms associated with opioid analgesic use after surgery, specifically nausea and drowsiness. In the early postoperative period, participants experienced pain at rest, and increased pain associated with physica l therapy exercises and mobility necessary for rehabilitation after joint arthroplasty surgery. It should be noted that there was incomplete data at each measurement point during the evening of surgery and on postoperative days 1 and 2 in hospital. This w as due to incomplete recording of study measures (pain intensity, pain distress, nausea, and drowsiness) by participants in hospital log booklets, and to variati ons in length of hospital stay among study participants. Table 4 6 summarizes the t ype of prescribed analgesic medications taken by study participants in hospital This table and figure represent the type of analgesia, both opioid and non opioid, prescribed for and taken by study patients in hospital.

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95 All study participants were presc ribed analgesic medications to treat postoperative pain. Most participants were administered analgesics on a routine basis. Oral opioid drugs taken as prescribed were oxycodone (87.2 % of participants) and tramadol (93.5% of participants). I n hospital p a rticipants could refuse routine ly prescribed analgesi cs and take these drugs on a pro re nata (PRN) or as needed basis for pain relief. Intravenous (IV) m orphine was prescribed for patient s on a prn basis for pain not controlled by routinely prescribe d oral opioids. O nly 25.5% of participants requested IV m orphine for pain relief during their hospital stay. Another analgesic drug prescribed for participants on a ro utine basis was the non opioid a cetaminophen. Oral a cetaminophen was tak en in hospital by alm ost all study participants (97.7%) Post Discharge Pain (intensity and distress) and opioid analgesic side e ffects (nausea and drowsiness) were assessed three tim es per day on days 1 and 2 post discharge from hospital. Descriptive results for thes e variables are presented separately for each symptom. See Tables 4 7 through Table 4 10 for summary of means. In addition, analgesic medication u se after discharge is presented in Table 4 11. The descriptive results indicate that participants in this s tudy continued to report experiencing moderate levels of pain from surgery during the first two days post discharge from hospital They reported mild to moderate symptoms of drowsiness and negligible symptoms of nausea after discharge from hospital It should be noted that there was incomplete data a t each measurement point during days 1 and 2 post discharge from hospital. This was due to incomplete recording of study measures (pain intensity, pain distress, nausea, and drowsiness) in discharge log book lets, to booklets

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96 not being mailed back to the investigator from study participants and to follow up telephone calls not being completed. Table 4 11 summarizes the type of prescribed analgesic medications taken by study participants post discharge from ho spital. This table and figure represent the type of analgesia, both opioid and non opioid, prescribed for and reportedly taken by p articipants post discharge from hospital. A nalgesic drugs were prescrib ed for pa rticipants on an as needed basis (prn) for pain relief in their discharge instructions from the hospital. P a rticipants were instructed by their physician to take oral oxycodone as needed for pain intensity of 8 or greater (on a scale of 0 to 10). O ral opioid oxycodone was taken by 54.2% of re porting pa rticipants post discharge O ral tramadol was also prescribed on a prn basis for pain (instructions by their physician were to take as needed for pain), and the majority of reporting pa rticipants (78 .3% ) took this opioid medication Similarly, the oral n on opioid ana lgesic a cetaminophen was prescribed to pa rticipants for use on an as needed basis and was tak en by about half 47.8%) of the reporting study p articipants for pain relief. Figure 4 2 presents the type of analgesic usage among reporting study participants post discharge from hospital Relationship between State Anxiety a n d Postoperative Symptoms Question #2. In adults undergoing joint replacement surgery, is state anxiety associated with postoperative symptoms of pain (intens ity and dist ress), nausea, and drowsiness the evening of surgery? State anxiety was measured once in this study, the evening of the day of surgery as a potential covariate. It was hypothesized that state anxiety would be significantly associated with pos toperative symptoms. Results indicate relatively low levels of

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97 anxiety in both groups (mean = 36.82 for treatment group; mean = 34.81 for control group). The results of correlation anal yse s are presented in Table 4 12 In the total sample, n o significan t relationship was found between state anxiety and pain intensity, pain di stress, nausea, or drowsiness measured the evening of surgery prior to first music listening time or first meal time after returning from surgery. Thus, state anxiety was not considered a covariate in subse quent analyses. Postoperative Pain Management Intervention: Nerve Block All patients in the study sample (N = 47) received nerve block intervention for pain management p ostoperatively. This in tervention was ordered for patients by the Acute Pain Service, Department of Anesthesiology, at the study hospital. L ength of time the nerve block remained in place varied signif icantly from patient to patient, ranging in hours from 13.0 to 119.0, with th e mean length of time in place being 34.9 hours. Fifty nine point one percent (59.1%) of study patients had their nerve block removed within 24 hours postoperatively while in hospital. Some study patients had the ir nerve block remain in place for up to 4 8 hours (27.3%), having it removed at a later time during their postoperative hospital stay. A sm all number of study patients (13. 6%) were discharged with the nerve block in place, having it later discontinu ed and removed by a visiting home care n urse. Clinical d ecisions about length of time the nerve block remained in place with patients varied and depended on a number of factors including reports of pain intensity from the patient, past allergies/adverse reactions to opioid analgesics experienced by t he patient, and patient preference of managing postoperative pain with anesthetic drugs r ather than opioid analgesics.

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98 Many factors related to the use of an anesthetic nerve block for postoperative pain m anagement with study patients were beyond controll ing for in this study; for example, type and amount of anesthetic drug used. However, the po tential confounding effect of nerv e block use in this study was examin ed by exam in in g the length of time the nerve block was in place for pa rticipants in the musi c group (mean = 29.27, SD = 22.47) compared to pa rticipants in the control group (mean = 40.52, SD = 36.23). Independent t T est results indicate there was no significant difference in length of time for nerve block placement between participants in the tw o groups (t = 1.24, df = 42, p = 0.22), thus this variable was not included as a covariate in further analyses. Effect of Intervention on Postoperative Symptoms Question 3. In adults undergoing joint replacement surgery, is a combined intervention (mu sic therapy plus analgesic medications) more effective than analgesic medications alone in reducing postoperative symptoms (pain intensity, pain distress, nausea, and drowsiness) the evening of surgery, during the first two postoperative days in hospital and during the first two day s post discharge from hospital? Analysis of covariance (ANCOVA) was used to test the effects of group membership (intervention versus control) on postoperative symptoms, controlling for pre treatment symptom levels. For partici pants in the intervention group, pre treatment symptom scores were used as the covariate. For those in the control group, measurement was conducted around meals. Thus, pre meal symptom scores w ere used as the covariate. R esults are presented for the first two postoperative days in hospital and for the first two days post discharge from hospital.

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99 Hospital The results indicate significant effects of the adjuvant music intervention on all four symptoms investigated. Compared to the control group, par ticipants in the music listening group had significantly lower pain intensity on the day of surgery and for the first two measurement points on postoperative day one. Pain distress was significantly lower in the music listening group than the control grou p on postoperative day 1 and day 2 No significant intervention effects were found for nausea or drowsiness. These results are summarized in Tables 4 13 through 4 16. It should be noted that there was incomplete data at each measurement point during the evening of surgery and on postoperative days 1 and 2 in hospital. This was due to incomplete recording of study measures (pain intensity, pain distress, nausea, and drowsiness) by participants in hospital log booklets, and to variations in length of hosp ita l stay among study participants. Post Discharge The results indicate significant effects of the adjuvant music intervention on two of the four symptoms investigated. Compared to the control group, participants in the music listening group had signi fica ntly lower pain intensity at all six measurement points during discharge day 1 and day 2 Pain distress was significantly lower in the music listening group at one measurement point on discharge day 1 and at two measurement points on discharge day 2. N o significant intervention effects were found for nausea or drowsiness during discharge day 1 and day 2. These results are summarized in Tables 4 17 through 4 20. It should be noted that there was incomplete data at each measurement point during discharg e days 1 and 2 post discharge from hospital. This was due to incomplete recording of study measures (pain intensity, pain distress,

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100 nausea, and drowsiness) in discharge log booklets by study participants to booklets not mailed bac k to the investigator fr om participants as requested, and to follow up telephone calls not completed. Effects of Intervention on Postoperative Analgesic Use Question 4 In adults undergoing joint arthroplasty surgery, do pa tients who receive the combined intervention (music therapy plus analgesic medications) use less opioid and non opioid analgesics than those pa tients who receive analgesic medications alone during the first two postoperative days in hospital and during the first two days post discharge from hospital? Independent t T est s w ere used to test the effects of group (intervention versus control) on analgesic usage. Total opioid analgesic usage was calculated by converting all opioid doses received by th e pa rticipant to m orphine equivalen cy using an Equivalent Opioid Calculator (ClinCalc.com) Similarly, total non opioid analgesic usage was to be calculated by converting all non opioid medications to acetaminophen equivalen cy In this study, however, a cetaminophen was the only non opioid medication prescribed or reported and thus conversion was not necessary. Results are presented for the first two postoperative days in hospital and for the first days post discharge from hospital. Hospital The result s indicate no significant effects of the adjuvant music intervention on opioid and non opioid analgesic usage between participants in the music group and those in the control group on the first and second postoperative days in hospital. These results are summarized in Table 4 21.

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101 Post Discharge The results indicate no significant effects of the adjuvant music intervention on opioid and non opioid analgesic usage between participants in the music group and those in the control group on the first two days post discharge from hospital. These results are summarized in Table 4 22 Perceptions of Music Intervention and Overall Pain Management Question 5. experience after surgery (music group ), and their perceptions of their overall pain experience in hospital after surgery (music and control groups)? Descriptive data add ressing this research question are listed in Table 4 2 4 which presents the rating s of responses from study participants in the music group to five questions listed in the after Surgery Survey Results from this survey indicate d that the majority of study participants in the music gro up perceived music listening as help ful in re duc ing acute surgical pain ( 88.9% either agreed or strongly agreed ) an d helpful in reducing anxiety after surgery (77.8% either agreed or strongly agreed ). Participants agreed or strongly agreed (83.4%) that the combined intervention of music therapy plus analgesic medications reduced the ir levels of postoperative pain after surgery. Importantly, participants agreed or strongly recommended (89.5%) music listening as an intervention for postoperative pain management for other patients undergoing surgery. Participants in both the intervention and control groups responded to five question s in the survey entitled, Survey Results in Table 4 24 indicate there were no significant differences between music and control group participants in responses to any of the five survey questions.

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102 T able 4 2 5 responses about their overall pain experience in the hospital. Results from this survey indicate d that the majority of study participants perceived their surgical pain in hospital to be well controlled (63.9% either agreed or strongly agreed) and their distress from pain well controlled ( 66.7% either agreed or strongly agreed). Participants agreed or strongly agreed ( 69.5%) tha t side effects ex perienced from opioid analgesics such as nausea and drowsiness, were well controlled in hospital. Lastly participants agreed or strongly agreed ( 66.7%) with the statement that pain medications worked well to control their pain in hospital.

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103 Table 4 1. Characteristics of the Sample, Overall and by Group (N = 50) Demographic Variables Total Sample (N = 50) Music Group (n=24) n % Control Group (n=26) n % Statistic df p value Age mean (SD) (n) 66.64 (8.72) 64.58 (8.81 ) (24) 6 8 69 (8. 62 ) (26) t = 1.67 48 0.10 Gender Male/ Female 21/29 11/13 (22%/26%) 10/16 (20%/32%) 1 0.60 Marital Status Married Widowed Divorced/separated Never married 36 7 10 7 10 (20%) 3 (6%) 7 (14%) 4 (8%) 16 (32%) 4 (8%) 3 (6%) 3 (6%) 3 0.36 Race White African American Asian 40 8 2 19 (38%) 4 (8%) 1 (2%) 21 (42%) 4 (8%) 1 (2%) 2 0.99 Highest Level of Education High school /GED Some college or vocational school College graduate Post graduate/professional 45 2 2 1 21 (42%) 1(2%) 1 (2%) 1 (2%) 24 (48%) 1(2%) 1 (2%) 0 (2%) 3 0.77 Concurrent Pain Condition 1 condition 2 3 conditions 43 7 20 (40%) 4 (8%) 23 (46%) 3 (6%) 1 0.60 Type of Surgery (N=47) 1 = knee 2 = hip 30 17 11 (23%) 10 (21%) 19 (40%) 7 (15%) 1 0.14 Revision Surgery (N=47) 1 = yes 2 = no 10 37 6 (13%) 15 (32%) 4 (8%) 22 (47%) 1 0.27

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104 Table 4 2. Mean Post Surgical Pain Intensity Scores a in Hospital Time Treatment Group Mean ( SD) (n) Control Group Mean ( SD) (n) Day of Surgery Time 3 ac b 4.56 (2.90 ) ( 16 ) 4.43 (2.84) ( 23 ) Time 3 pc c 4.29 (2.87 ) ( 14 ) 4.45 (2.58 ) ( 22 ) Postoperative Day One Time 1 ac 4.20 (2.29 ) ( 20 ) 4.13 (2.88) ( 23 ) Time 1 pc 3.53 (2.34) ( 19 ) 4.17 (2.86 ) ( 23 ) Time 2 ac 4.21 (2.37) ( 19 ) 4.62 (3.09) ( 21 ) Time 2 pc 3.29 (2.02) ( 17 ) 4 .33 (3.09 ) ( 21 ) Time 3 ac 5.00 (2.67) ( 8 ) 5.00 (2.30) ( 10 ) Time 3 pc 5.00 (2.08 ) ( 7 ) 5.70 (2.50 ) ( 10 ) Postoperative Day Two Time 1 ac 4.30 (2.63 ) ( 10 ) 5.80 (2.66 ) ( 10 ) Time 1 pc 4.00 (2.18 ) ( 9 ) 5.50 (2.46) ( 10 ) Time 2 ac 5.57 (2.15 ) ( 7 ) 6.25 (2.25) ( 8 ) Time 2 pc 4.71 (2.69) ( 7 ) 5.88 (2.10) ( 8 ) Time 3 ac 5.75 (2.06) ( 4 ) 7.00 (2.00) (3) Time 3 pc 4.75 (2.63 ) (4) 7.00 (2.00 ) (3) a Pain intensity measured on 0 10 scale (NRS) b ac = before music (treatment group) or before meal (control group); c pc = after music (treatment group) or after meal (control group)

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105 Table 4 3. Mean Post Surgical Pain Distress Scores a in Hospital Time Treatment Group Mean (SD) (n) Control Group Mean (SD) (n) Day of Surgery Time 3 ac b 3.25 (3.53 ) ( 16 ) 2.70 (3.05 ) ( 23 ) Time 3 pc c 2.67 (3.20 ) ( 15 ) 2.43 (2.73 ) ( 23 ) Postop Day One Time 1 ac 2.50 (2.54 ) ( 20 ) 2.57 (2.33 ) ( 23 ) Time 1 pc 1.40 (1.73 ) ( 20 ) 2.70 (2.95) ( 23 ) Time 2 ac 2.32 (2.52 ) ( 19 ) 3.38 (3.01 ) ( 21 ) Time 2 pc 1.44 (1.58 ) ( 18 ) 3.14 (3.10 ) ( 21 ) Time 3 ac 3.63 (2.77 ) ( 8 ) 4.90 (3.45 ) ( 10 ) Time 3 pc 2.75 (2.05 ) ( 8 ) 4.70 (3.23 ) ( 10 ) Postop Day Two Time 1 ac 2.80 (2.15 ) ( 10 ) 3.10 (2.96 ) ( 10 ) Time 1 pc 1.89 (1.83 ) ( 9 ) 3.10 (2.96 ) ( 10 ) Time 2 ac 4.14 (3.13 ) ( 7 ) 4.38 (2.88 ) ( 8 ) Time 2 pc 2.71 (2.43 ) ( 7 ) 4.38 (2.88 ) ( 8 ) Time 3 ac 4.50 (2.52 ) ( 4 ) 3.33 (3.51 ) ( 3 ) Time 3 pc 3.75 (2.99 ) ( 4 ) 3.00 (3.00 ) ( 3 ) a Pain distress measured on 0 10 scale (NRS) b ac = before music (treatment group) or before meal (control group); c pc = after music (treatment group) or after meal (control group)

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106 Table 4 4. Mean Post Surgical Nausea Scores a in Hospital Time Treatment Group Mean (SD) (n) Control Group Mean (SD) (n) Day of Surgery Time 3 ac b 0.94 (2.57 ) ( 16 ) 0.83 (2.10 ) ( 23 ) Time 3 pc c 0.50 (1.87 ) ( 14 ) 0.83 (2.10 ) ( 23 ) Postoperative Day One Time 1 ac 0.35 (1.56 ) ( 20 ) 1.70 (3.46 ) ( 23 ) Time 1 pc 0 .16 (.69 ) ( 19 ) 1.65 (3.39 ) ( 23 ) Time 2 ac 0.32 (1.16 ) ( 19 ) 1.10 (2.57 ) ( 21 ) Time 2 pc 0 .06 (0.24) ( 17 ) 1 .05 (2.44 ) ( 21 ) Time 3 ac 0.63 (1.77 ) ( 8 ) 0.70 (2.21 ) ( 10 ) Time 3 pc 0 .00 (0.00 ) ( 7 ) 0.70 (2.21 ) ( 10 ) Postoperative Day Two Time 1 ac 1.00 (2.11) ( 10 ) 0.60 (1.90 ) ( 10 ) Time 1 pc 1.11 (2.21 ) ( 9 ) 0 .60 (1. 90 ) ( 10 ) Time 2 ac 0.50 (1.07 ) ( 8 ) 0 .00 ( 0 .00) ( 8 ) Time 2 pc 0 .63 (0.92 ) ( 8 ) 0 .00 ( 0 .00) ( 8 ) Time 3 ac 0 .60 (0.89 ) ( 5 ) 0 .00 ( 0 .00) ( 3 ) Time 3 pc 0 .25 (0.50 ) (4) 0 .00 ( 0 .00) ( 3 ) a Nausea measured on 0 10 scale (NRS) b ac = before music (treatment group) or before meal (control group); c pc = after music (treatment group) or after meal (control group)

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107 Table 4 5. Mean Post Surgical Drowsiness Scores a in Hospital Time Treatment Group Mean (SD) (n) Control Group Mean ( SD) (n) Day of Surgery Time 3 ac b 2.06 (2.98 ) ( 16 ) 3.17 (3.66 ) ( 23 ) Time 3 pc c 1.71 (2.87 ) ( 14 ) 3.48 (3.85 ) ( 23 ) Postoperative Day One Time 1 ac 1.65 (3.28 ) ( 20 ) 3.70 (3.60 ) ( 23 ) Time 1 pc 1.68 (3.37 ) ( 19 ) 3.57 (3.68) ( 23 ) Time 2 ac 2.37 (3.66 ) ( 19 ) 4.6 2 (3.51 ) ( 21 ) Time 2 pc 2.59 (3.81 ) ( 17 ) 4.52 (3.61 ) ( 21 ) Time 3 ac 2.13 (3.68 ) ( 8 ) 4.00 (3.30 ) ( 10 ) Time 3 pc 2.29 (3.95 ) ( 7 ) 4.00 (3.30 ) ( 10 ) Postoperative Day Two Time 1 ac 1.60 (2.50 ) ( 10 ) 2.50 (2.68 ) ( 10 ) Time 1 pc 1.78 (2.59 ) ( 9 ) 2.50 (2.68 ) ( 10 ) Time 2 ac 1.63 (2.78 ) ( 8 ) 3.88 (3.95 ) ( 8 ) Time 2 pc 1.63 (2.77 ) ( 8 ) 3.88 (3.95 ) ( 8 ) Time 3 ac 0.25 (0.50 ) ( 4 ) 3.33 (5.78 ) ( 3 ) Time 3 pc 0.25 (0.50 ) ( 4 ) 3.33 (5.78 ) ( 3 ) a Drowsiness measured on 0 10 scale (NRS) b ac = before music (treatment group) or before meal (control group); c pc = after music (treatment group) or after meal (control group)

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108 Table 4 6. Type of Analgesic Medications taken by Study Participants in Hospital Analgesic Drug Type Administered Yes No Opioid Oxycodone PO a 87.2% 12.8% Tramadol PO 93.5 % 6.5% Morphine IV b 25. 5% 74.5% Non Opioid Acetaminophen PO 97.9% 2.1% a by mouth; oral b intravenous

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109 Figure 4 1. Type of Analgesic Usage among Study Participants in Hospital. 0 10 20 30 40 50 60 70 80 90 100 Oxycodone PO Tramadol PO Morphine IV Acetaminophen PO Percentage Drug Type Usage Yes No

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110 Table 4 7. Mean Post Surgical Pain Intensity Scores a after Discharge Time Treatment Group Control Group Mean (SD) (n) Mean (SD) (n) Discharge Day One Time 1 ac b 4.92 (2.19) ( 12 ) 6.47 (2.22) ( 19 ) Time 1 pc c 3.50 (2 .0 7 ) ( 12 ) 6.21 (2.4 9 ) ( 19 ) Time 2 ac 4.92 (1.68 ) ( 12 ) 5.56 (2.38) ( 18 ) Time 2 pc 3.25 (2.10 ) ( 12 ) 5.61 (2.33) ( 18 ) Time 3 ac 5.14 (1.68 ) ( 7 ) 6.17 (2.09) ( 18 ) Time 3 pc 3.57 (1.81) ( 7 ) 6.00 (2.30 ) ( 18 ) Discharge Day Two Time 1 ac 4.60 (2.27) ( 10 ) 5.56 (2.43 ) ( 18 ) Time 1 pc 3.00 (2.16) ( 10 ) 5.39 (2.40) ( 18 ) Time 2 ac 4.33 (1.92) ( 12 ) 5.28 (2.11 ) ( 18 ) Time 2 pc 2.93 (1.98 ) ( 12 ) 5.00 (2.25 ) ( 18 ) Time 3 ac 4.14 (1.87 ) ( 7 ) 5.18 (1.88) (1 7 ) Time 3 pc 2.43 (2.15 ) ( 7 ) 4.71 (2.09) (1 7 ) a Pain intensity measured on 0 10 scale (NRS) b ac = before music (treatment group) or before meal (control group) c pc = after music (treatment group) or after meal (control group)

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111 Table 4 8. Mean Post Surgical Pain Distress Scores a after Discharge Time Treatment Group Control Group Mean (SD) (n) Mean (SD) (n) Discharge Day One Time 1 ac b 3.00 (2.49 ) ( 12 ) 4.79 (2.88 ) ( 19 ) Time 1 pc c 2.17 (2.33 ) ( 12 ) 4.42 (3.01 ) ( 19 ) Time 2 ac 2.58 (2.50 ) ( 12 ) 4.11 (2.95 ) ( 18 ) Time 2 pc 1.92 (2.35 ) ( 12 ) 3.94 (3.08 ) ( 18 ) Time 3 ac 3.29 (2.75 ) ( 7 ) 4.56 (2.75 ) ( 18 ) Time 3 pc 2.29 (2.22 ) ( 7 ) 4.33 (2.89 ) ( 18 ) Discharge Day Two 2.30 (2.98 ) ( 10 ) 4.06 (2.71 ) ( 18 ) Time 1 pc 1.20 (2.10 ) ( 10 ) 3.61 (2.55 ) ( 18 ) Time 2 ac 2.08 (2.35 ) ( 12 ) 3.50 (2.09 ) ( 18 ) Time 2 pc 1.25 (1.87 ) ( 12 ) 3.11 (2.37 ) ( 18 ) Time 3 ac 1.71 (2.06 ) (7) 3.00 (2.37 ) ( 17 ) Time 3 pc 0.86 (1.57 ) (7) 2.82 (2.40 ) ( 17 ) a Pain distress measured on 0 10 scale (NRS) b ac = before music (treatment group) or before meal (control group) c pc = after music (treatment group) or after meal (control group)

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112 T able 4 9. Mean Post Surgical Nausea Scores a after Dis charge Time Treatment Group Control Group Mean (SD) (n) Mean (SD) (n) Discharge Day One Time 1 ac b 1.42 (3.03 ) ( 12 ) 1.11 (2.36 ) ( 19 ) Time 1 pc c 1.42 (3 .03 ) ( 12 ) 1.11 (2.36 ) ( 19 ) Time 2 ac 1.08 (2.47 ) ( 12 ) 1.00 (1.97 ) ( 18 ) Time 2 pc 1.08 (2.47 ) ( 12 ) 1.00 (1.97 ) ( 18 ) Time 3 ac 0.29 0.76 ) ( 7 ) 0.89 (1.68 ) ( 18 ) Time 3 pc 0.29 (0.76) ( 7 ) 0.89 (1.68 ) ( 18 ) Discharge Day Two Time 1 ac 0.70 (1.49 ) ( 10 ) 0.78 (1.59 ) ( 18 ) Time 1 pc 0.70 (1.49 ) ( 10 ) 0.78 (1.59 ) ( 18 ) Time 2 ac 0 .17 ( 0.58) ( 12 ) 0.61 (1.42 ) ( 18 ) Time 2 pc 0 .17 ( 0.58) ( 12 ) 0.61 (1.42 ) ( 18 ) Time 3 ac 0 .29 ( 0.76) ( 7 ) 0.53 (1.18 ) ( 17 ) Time 3 pc 0 .29 ( 0.76 ) ( 7 ) 0.53 (1.18 ) ( 17 ) a Nausea measured on 0 10 scale (NRS) b ac = before music (treatment group) or before meal (control group) c pc = after music (treatment group) or after meal (control group)

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113 Table 4 10. Mean Post Surgical Drowsiness Scores a after Discharge Time Treatment Group Control Group Mean ( SD) (n) Mean (SD) (n) Discharge Day One Time 1 ac b 3.00 (2.49 ) ( 12 ) 4.79 (2.88 ) ( 19 ) Time 1 pc c 2.17 (2.33 ) ( 12 ) 4.42 (3.01 ) ( 19 ) Time 2 ac 2.58 (2.50 ) ( 12 ) 4.11 (2.95 ) ( 18 ) Time 2 pc 1.92 (2. 35 ) ( 12 ) 3.94 (3.08 ) ( 18 ) Time 3 ac 3.29 (2.75 ) ( 7 ) 4.56 (2.75 ) ( 18 ) Time 3 pc 2.29 (2.22 ) ( 7 ) 4.33 (2.89 ) ( 18 ) Discharge Day Two Time 1 ac 2.30 (2.98 ) ( 10 ) 4.06 (2.71 ) ( 18 ) Time 1 pc 1.20 (2.10 ) ( 10 ) 3.61 (2.55 ) ( 18 ) Time 2 ac 2.08 (2.35 ) ( 12 ) 3.50 (2.09 ) ( 18 ) Time 2 pc 1.25 (1.87 ) ( 12 ) 3.11 (2.37 ) ( 18 ) Time 3 ac 1.71 (2.06 ) ( 7 ) 3.00 (2.37 ) ( 17 ) Time 3 pc 0.86 (1.57 ) ( 7 ) 2.82 (2.40 ) ( 17 ) a Drowsiness measured on 0 10 scale (NRS) b ac = before music (treatment group) or before meal (control group) c pc = after music (treatment group) or after meal (control group)

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114 Table 4 11.Type of Analg esic Medications taken by Reporting Study Participants after Discharge Analgesic Drug Type Administered Yes No Opioids Oxycodone PO a 54.2% 45.8% Tramadol PO 78.3% 21.7% Non Opioid Acetaminophen PO 47.8% 52.2% a by mouth; oral

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115 Figure 4 2. Type of Analgesic Usage among Reporting Study Participants after Discharge 0 10 20 30 40 50 60 70 80 90 Oxycodone PO Tramadol PO Acetaminophen PO Percentage Drug Type Usage Yes No

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116 Table 4 12. Co rrelations between State Anxiety and Postoperative Symptoms the Evening of Surgery in Hospital ac scores (before music time or mealtime) State Anxiety r (n) p value Pain Intensity 0.20 0.25 Pain Distress n=36 0.31 0.06 n=36 Nausea Drowsiness 0.76 0.66 n=36 .054 0.75 n=36

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117 Figure 4 3. Length of Time Nerve Block in Place Postoperatively for Study Patients 0 20 40 60 80 100 up to 24 hours up to 48 hours up to 120 hours Percentage Hours Postoperative

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118 Table 4 13. Comparison of Post test Pain Intensity Scores between Music and Control Groups Controlling for Pre test scores (ANCOVA) in Hospital Time Period Music Group Adjusted Means (n) Control Group Adjusted Means (n) F p value Day of Surgery Time 3 3.94 (14) 4.67 (22) 5. 70 0 .02* Postop Day 1 Time 1 3.39 (19) 4.29 (23) 4.52 0.04 Time 2 3 .25 (17) 4.36 (21) 6.7 4 0.01 Time 3 5.05 (7) 5.67 (10) 1.76 0.21 Postop Day 2 Time 1 4.49 (9) 5.06 (10) 3.60 0 08 Time 2 5.08 (7) 5.55 (8) 1.10 0.31 Time 3 5.36 (4) 6.18 (3) 2.60 0.18 p < 0.05 level

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119 Table 4 14. Comparison of Post test Pain Distress Scores b etween Music and Control Groups, Controlling for Pre test scores (ANCOVA) in Hospital Time Period Music Group Adjusted Means (n) Control Group Adjusted Mean (n) F p value Day of Surgery Time 3 2.28 (15) 2.69 (23) 1.32 0.26 Postop Day 1 Time 1 1.42 (20) 2.67 (23) 5.69 0.02 Time 2 1.86 (18) 2.79 (21) 7.26 0.01 Time 3 3.33 (8) 4.24 (10) 3.40 0.09 Postop Day 2 Time 1 1.88 (9) 3.11 (10) 12.54 0 .003** Time 2 2.81 (7) 4.30 ( 8) 3.19 0.09 Time 3 3.26 (4) 3.65 (3) 0.29 0 .62 p < 0.05 level ** p < 0.005 level

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120 Table 4 1 5. Comparison of Post test Nausea S cores between Music and Control Groups Controlling for Pre test scores (ANCOVA) in Hospital Time Period Music Group Adjusted Means (n) Control Group Adjusted Mea ns (n) F p value Day of Surgery Time 3 0.70 (14) 0 .70 (23) 0 00 1.00 Postop Day 1 Time 1 1.07 (19) 0.90 (23) 1.09 0.30 Time 2 0.60 (17) 0.61 (21) 0.02 0.89 Time 3 0.41 (7) 0.41 (10) n/c* n/c* Postop Day 2 Time 1 0.84 (9) 0.84 (10) n/c* n/c* Time 2 0.48 (8) 0.14 (8) 1.63 0 .22 Time 3 0.14 (4) 0 14 (3) n/c* n/c* n/c = not calculated/sample sizes insufficient

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121 Table 4 16. Comparison of Post test Drowsiness Scores between Music and Control Groups Controlling for Pre test scores (ANCOVA) in Hospital Time Period Music Group Adjusted Means (n) Control Group Adjusted Means (n) F p value Day of Surgery Time 3 2.60 (14) 2.94 (23) 0 .6 8 0.42 Postop Day 1 Time 1 2.79 (19) 2.65 (23) 0 8 4 0.37 Time 2 3.72 (17) 3 .61 (21) 1. 12 0.30 Time 3 3.29 (7) 3.29 (10) n/c* n/c* Postop Day 2 Time 1 2.16 (9) 2.16 (10) 0.00 1.00 Time 2 2.75 (8) 2.75 (8) n/c* n/c* Time 3 1.57 (4) 1.57 (3) n/c* n/c* n/c = not calculated/sample sizes insufficient

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122 Table 4 17. Comparison of Post test Pain Intensity S cores between Music and Control Groups Controlling for Pre test scores (ANCOVA) after Discharge Time Period Music Group Adjusted Means (n) Control Group Adjusted Means (n) F p value Disch. Day 1 Time 1 4.46 (12) 5.61 (19) 16.38 0 .000** Time 2 3.64 (12) 5.35 (18) 58.18 0 .000** Time 3 4.35 (7) 5.70 (18) 2 4.01 0. 000** Disch. Day 2 Time 1 3.57 (10) 5.07 (18) 28.25 0 .000** Time 2 3.48 (12) 4.63 (18) 16.68 0 .000** Time 3 3.18 (7) 4.40 (17) 9.22 0 .006* p < 0.05 level **p < 0.00 level

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123 Table 4 18. Comparison of Post test Pain Distress Scores between Music and Control Groups Contr olling for Pre test scores (ANCOVA) after Discharge Time Period Music Group Adjusted Means (n) Control Group Adjusted Means (n) F p value Disch. Day 1 Time 1 3.11 (12) 3.83 (19) 1.54 0.23 Time 2 2.81 (12) 3.35 (18) 3.43 0.08 Time 3 3.15 (7) 4.00 (18) 5 .12 0.03 Disch. Day 2 Time 1 2.04 (10) 3.14 (18) 4.95 0.04 Time 2 2.01 (12) 2.60 (18) 2.47 0.13 Time 3 1.69 (7) 2.48 (17) 5.76 0.03 * p < 0.05 level

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124 Table 4 19. Comparison of Post test Nausea Scores between Music and Control Groups Controlling for Pre test scores (ANCOVA) after Discharge Time Period Music Group Adjusted Means (n) Control Group Adjusted Means (n) F p value Disch. Day 1 Time 1 1.23 (12) 1.23 (19) 0 .00 1.00 Time 2 1.03 ( 12) 1 .03 (18) 0 .00 1.00 Time 3 0.72 (7) 0.72 (18) 0 .00 1.00 Disch. Day 2 Time 1 0.75 (10) 0.75 (18) 0 .00 1.00 Time 2 0.43 (12) 0.43 (18) n/c* n/c* Time 3 0.46 ( 7) 0.46 (17) n/c* n/c* n/c = not calculated/sample sizes insufficient

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125 Table 4 20. Comparison of Post test Drowsiness Scores between Music and Control Groups Controlling for Pre test scores (ANCOVA) after Discharge Time Period Music Group Adjusted Means (n) Control Group Adjusted Means (n) F p value Disch. Day 1 Time 1 1.87 (12) 1.87 (19) n/c* n/c* Time 2 1.70 (12) 1.70 (18) 0.00 1.00 Time 3 1.88 (7) 1.88 (18) 0.00 1.00 Disch. Day 2 Time 1 1.71 (10) 1 .71 (18) 0.00 1.00 Time 2 1.57 (12) 1.51 (18) 0.62 0.44 Time 3 1.79 (7) 1.79 (17) 0.00 1.00 n/c = not calculated/sample sizes insufficient

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126 Table 4 21. Comparison of Total Analgesic Usage (Opioid and Non Opioid) between Music a nd Control Groups in Hospital Independent t test Drug Type/ Surgical Day Music Group Mean (SD) (n) Control Group Mean (SD) (n) t do p value OME a Total Postop Day 1 51.52 (37.49) ( 23 ) 35.00 (27 43) ( 23 ) 1.71 44 0.10 OME a Total Postop Day 2 42.81 (35.54) (16) 40.56 (32.93) ( 9 ) 0.16 23 0.88 NOAE b Total Postop Day 1 1814.58 (1027.39) (24) 1554.35 (969.85) (23) 0.89 45 0.38 NOAE b Total Postop Day 2 1746.88 (1310.12) (16) 1661.11 (1715.47) (9) 0 14 23 0.89 a OME = Opioid Morphine Equivalency (mg) b NOAE = Non Opioid Acetaminophen Equivalency (mg)

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127 Table 4 22. Comparison of Reported Total Analgesic Usage (Opioid and Non Opioid) between Music and Control Groups after Discharge Independent t test Drug Type/ Surgical Day Music Group Mean (SD) (n) Control Group Mean (SD ) (n) t df p value OME a Total Discharge Day 1 18.33 (14.38) ( 6 ) 21.00 (23.29) ( 5 ) 0.23 9 0.82 OME a Total Discharge Day 2 23.75 (29.26) ( 4 ) 15.83 (22.23) ( 6 ) 0.49 8 0.64 NOAE b Total Discharge Day 1 354.17 (607.54) ( 6 ) 600.17 (800.10) (6) 0.60 10 0.56 NOAE b Total Discharge Day 2 575.00 (675.14) ( 4 ) 516.67 (775.67) ( 6 ) 0.12 8 0.91 a OME = Opioid Morphine Equivalency (mg) b NOAE = Non Opioid Acetaminophen Equivalency (mg)

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128 Table 4 23. Music Listening Experience after Surgery Survey Responses (N = 17) Survey Question Strongly Agree Agree Neither Agree Nor Disagree Disagree Strongly Disagree Q1. Music Choice Good for Me 55.6% 33.3% 11.1% 0.0% 0.0% Q2. Music Reduced Pain 16.7% 72.2% 5.6% 5.6% 0.0% Q3. Music Reduced Anxiety 16.7% 61.1% 16.7% 5.6% 0.0% Q4. Pain Meds Music Reduced Pain 27.8% 55.6% 5.6% 11.1% 0.0% Q5. Would Recommend Music 42.1% 47.4% 5.3% 5.3% 0.0%

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129 Table 4 24. Overall Pain Experience after Surgery Survey by Group (N=36) Survey Question Music Group (n=18) n % Control Group (n=18) n % Chi Square df p value Q. 1.My pain in hospital after surgery was what I expected a 11(61.1) b 4(22.2) c 3(16.7) 11(61.1) 3(16.7) 4(22.2) 2 0.87 Q. 2. Intensity of my pain in hospital after surgery was well controlled 12(66.7) 1( 5.6) 5(27.8) 11(61.1) 3(16.7) 4(22.2) 2 0.56 Q. 3. Distress I experienced from pain in hospital after surgery was well controlled 12(33.3) 3(16.7) 3(16.7) 12(33.3) 3(16.7) 3(16.7) 2 1.00 Q. 4. The side effects from pain medication received in hospital after surgery were well controlled 12(66.7) 3(16.7) 3(16.7) 12(66.7) 3(16.7) 3(16.7) 2 0.89 Q. 5. Pain medication received in hospital after surgery worked well to control my pain. 13(72.2) 2(11.1) 3(16.7) 11(61.1) 4(22.2) 3(16.7) 2 0.66 a agree or strongly agree b neither agree nor disagree c disagree or strongly disagree

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130 Table 4 25. Overall Pain Experience i n Hospital Survey Responses (N = 36) Survey Question Strongly Agree Agree Neither Agree Nor Disagree Disagree Strongly Disagree Q1. Pain Was What I Expected 13.9% 47.2% 19.4% 16.7% 2.8% Q2. Pain Intensity Controlled 27.8% 36.1% 11.1% 25.0% 0.0% Q3. Pain Distress Controlled 16.7% 50.0% 16.7% 16.7% 0.0% Q4. Pain Med SEs Controlled 13.9% 55.6% 13.9% 16.9% 0.0% Q5. Pain Meds Controlled Pain 27.8% 38.9% 16.7% 11.1% 5.6%

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131 C HAPTER 5 DISCUSSION Summary of Results In a sample of adult patients who had undergone total knee or hip joint arthroplasty surgery, the effect of a music intervention on reducing levels of pain intensit y, pain distress, opioid side effects of nausea and d rowsiness, and opioid and non opioid analgesic usage the evening of surgery, dur ing the first two postoperative days in hospital, and the first two days post discharge from hospital was examined. Forty seven patients participated in this prospective random ized trial. The results of this study are summarized here. As expected, pa rticipants in the study who had undergone knee or hip joint arthroplasty surgery experienced acute pain after surgery. Although all study pa rticipants received an anesthetic nerve block to help manage pain after surgery, and all participants were given or had available to them, opioid and non opioid analgesics to relieve pain, they still reported experiencing moderately intense pain. In hospital m ean pain intensity scores we re relatively consistent for participants across the evening of surgery, and postoperative days 1 and 2 day study period s ( mean scores across groups ranging from 3.50 to 7.00 on a 0 10 numerical rating scale), and continued to be relatively consistent for participants post discharge on discharge days 1 and 2 (mean scores across groups ranging from 2.43 to 6.47). Pain distress scores revealed lower levels of distress across the in hospital study period s (mean scores across groups ranged from 1.4 0 to 4. 38), and continued to be relatively consistent for participants across the post discharge study periods (mean scores across groups ranged from 0.86 to 4.79) The availability of options for relief of postoperative pain (intravenous

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132 morphine prn, application of ice therapy and therapeutic positioning) may have contributed to lower levels of reported pain distress after surgery. T he symptom of postoperative nausea was infrequent and well controlled with prophylactic anti emetics during the e arly postoperative period. N ausea once discharged from hospital was insignificant as the clinical reasons for its occurrence no longer exist ed (that is, post anesthetic nausea typically resolves wi thin 24 hours after surgery ). However, opioid analgesic us age among study participants post discharge likely contributed to its existence after discharge. Pa rticipants reported very low levels of nausea across the in hospital study periods ( mean scores across groups ranged from 0.0 0 to 1.70 ), and across the post discharge study periods ( mean scores across groups ranged from 0. 29 to 1. 42). Participants reported experiencing mild to moderate drowsiness during hospitalization likely due to sleep deprivation before surgery, anesthetic and analgesic drugs gi ven intr aoperatively, sleep interruption during hospitalization, and side effects of opioid analgesics taken for pain control. L ow to moderate levels of drowsiness were reported by participants during in hospital study periods (mean scores across groups ranging from 0.25 to 4.62 ) and during post discharge study periods (mean scores across groups ranging from 0.86 to 4.79 ). As expected, p a rticipants were prescribed opioid and non opioid analgesic medication s to be given routinely dur ing the first two post operativ e days in hospital, and all but one participant took analgesic drugs to treat pain. They were prescribed on an as needed basis, opioid and non opioid analgesic medication s for use post discharge. P articipants took oral o xycodone, or al t ramadol and or al ac etaminophen for pain relief after surgery. In the early postoperative period, t hey experienced pain at rest, and

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133 increased pain associated with physical therapy exercises and mobility necessary for rehabilitation after joint arthroplasty surgery. Anx iety is an emotional response to a stressful event, and surgery is perceived by many individuals as a stressful event. Thus, i t was hypothesized that state anxiety would be significantly associated with postoperative pain and related symptoms In this stu dy, levels of state anxiety were relatively low and not significantly related to the postoperative symptoms; t hus, this hypothesis was not supported. This may be due to the fact that participants were relieved that their surgery was complet e and they would now get relief from the chronic pain they had been experiencing before surgery. Also, all participants received an anesthetic nerve block postoperatively, thus relieving, or for some participants eliminating acute pain in the immediate po stoperative period ( i.e. the evening of surgery). Perhaps measuring state anxiety later in the postoperative period, for example, on postoperative day 1 or 2, along with pain intensity and distress, or measuring trait anxiety (that is, the stable tendenc y to attend to experiences, and report negative emotions across many situations) would more accurately reflect the measure of postoperative anxiety experienced by participants in this study. The purpose of this study was to evaluate whether music as an a dj uvant analgesics would reduce pain and related postoperativ e symptoms more that analgesic medications alone The results revealed patients who participated in the music intervention had significantly lower levels of pain intensity and pain distress during the first 24 hours postoperatively, and during the first 24 48 hours post discharge than those in the control group (analgesic s medications only ). No group differences were detected during the second postoperative day in hospital. This is likely due to missing

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134 data because of varied discharge days from hospital among study participants Many s tudy participants were discharged from hospital on postoperative day 1 (n=20; 43%), some on postoperative day 2 (n=16; 34%), and some on postope rative day 3 (n=10, 21%). Time of discharge on discharge days was typically 12 noon. ( One study participant was discharged on postoperative day 4 ) Controlling for pre test levels of pain intensity and pain distress, the study results revealed significant group differenc es in treatment effects, with significantly lower post test pain scores for those who participated in music listening. Thus, the hypothesis was supported for the first 24 hours postoperatively and 24 48 hours post discharge from hospital. With regard to the other postoperative symptoms, there were no significant differences between music and control group participants in levels of nausea, drowsiness, or analgesic usage at any of the time period s in hospital or post discharge. This was likely due in pa rt to use of a nerve block to manage postoperative pain the first 24 hours after surgery. For many participants, this resulted in less pain and therefore less use of opioid analgesics for pain relief. Use of less opioid analgesics resulted in fewer side e ffects associated with opioid use ( i.e. nausea and drowsiness) With nausea, effective usage of anti emetic drugs after surgery likely contributed to the decreased incidence of this postoperative symptom after surgery. Therefore, the hypothesis that adju vant music would significantly lower nausea and drowsiness and reduce analgesic usage was not supported Many factors can influence analgesic usage with patients who have undergone surgery. In this study, use of an anesthetic nerve block in hospital and f or some participants, continued use after discharge, likely influenced participant reports of pain

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135 intensity and pain distress, reports of opioid side effects of nausea and drowsiness, and analgesic usage in hospital and after discharge. Nerve block provi des superior analgesia for surgical patients without the side effects associated with opioid analgesic use. Prescribed analgesics used and use of an anesthetic nerve block, its drugs and dosing, were not controlled for in this study. However, there were no significant differences found between music group participants and control group participants in opioid or non opioid analgesic taken in hospital or reportedly taken by participants post discharge from hospital. Further, there was no significant diffe rence in length of time for nerve block placement between participants in the study groups. A nesthetic nerve block usage among study participants was not controlled for in this study On the third day post discharge from hospital, participants in the study were asked to rate their overall pain experience in hospital after surgery, and those in the music listening group were asked to rate their music listening experience after surgery. Participants expressed satisfaction with their postoperativ e pain management. The majority of respondents reported that pain was well controlled, nausea and drowsiness were well managed, and that analgesics were effective in reducing pain. Those who received adjuvant music therapy perceived music listening as help ful in reducing surgical pain and anxiety. Further, these participants strongly recommended music listening as an intervention for postoperative pain management Use of an adjuvant therapy, specifically music listening, was found in this study to help relieve pa pain after surgery both the acute surgical pain experienced in hospital and the acute surgical pain experienced after discharge from hospital. These findings y However, among treatment group

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136 participants in this study, use of music listening after surgery did not impact the amount of opioid or non opioid analgesics taken by pa rticipants after surgery, nor did it impact the levels of nausea or drowsiness experienced by study pa rticipants after surgery. T y Good and nursing pain management theory, first publishe d in 1996, does not reflect current practice with patients undergoing orthopedic surgery in terms of pain management; that is, use of nerve block for pain management the first 24 hours postoperatively, and prophylactic use of anti emetic drugs t o control t he symptom of nausea. T herefore this theory may not be the best fit for this study to help exp lain the relationships among study variables. Strengths and Limitations of the Study This was the first randomized trial study that examined the use of a mu sic intervention as adjuvant therapy along with prescribed analgesia to help reduce acute surgical pain in both the hospital and post discharge (home) settings. The randomized trial design chosen for use in this study and the study protocol examining effe ct over time are both strengths of th e in hospital from the electronic medical record (EPIC) made recording these data feasible, accurate, and complete, and is also a strength of the study. The ab ility to collaborate with the Orthopedic Center surgeons, nurses, and clinical research coordinator to facilitate recruitment was key to successful recruitment. This partnership facilitated the introduction of the study to the patients at their preoperati ve clinic visit, and greatly facilitated enrollment and timely completion of this study. This collaboration was a strength of th e study.

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137 A limitation of this study was its small sample size. This study was intended as a pilot study to test the feasibili ty of using post discharge assessments and the use of personal portable music devices. The sample size of 50 for this study was determined based on a p ower analysis using a n estimated large effect size (d=.80) power of 0. 8 0 and alpha = 0.05 (Coh en, 1988) However, there was loss of data at several measurement points both in the hospital and post discharge that resulted in small sample sizes for specific comparisons. Using robust parametric statistics like Analysis of Covariance (ANCOVA) in this study do es violate some assumptions of its use; for example, normality, homogeneity of variance, and random independent samples. Therefore, the study should be replicated with a larger sample size in order to reduce the risk of Type II error and strengthen stati stical conclusion validity, Problems with implementing the study intervention was a limitation of the study. Some music group participants Wi Fi system (broadband wireless network) to access the ir on line radio for music listening. At times, internet Wi Fi system access varied from hospital room to hospital room on the orthopedic unit. The nursing staff informed participants that this was commonplace at times in the hospital. This resulted in music group participants needing to use the internet access system of their own device. If a music therapy program were to be implemented in this clinical setting, and importantly showed improved patient outcomes and satisfaction with hospital care, this might be the impetus needed by ad ministration in the clinical agency to improve internet access to the Fi system for hospitalized patients.

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138 Challenges with carrying out the study intervention was a limitation of the study. In the busy and noisy hospital environment, music listening for some music group participants was interrupted, in spite of signage on their hospital door indicating that music and con trol groups experienced postoperative symptoms of nausea, vomiting, or drowsiness which affected their ability to either carry out music listening or to eat at scheduled mealtimes. Analgesic drug administration before music listening with treatment grou p participants was not measured in this study. Further, analgesic drug administration before mealtimes with control group participants was not measured in the study. Therefore, these omissions threatened the internal validity of the study and is a limita tion of the study. Study participants were discharged from hospital after surgery at various times during their postoperative course postoperative day 1, day 2, or day 3. The orthopedic hemodynamic stability, acceptable pain levels, absence of postoperative symptoms of nausea, vomiting, and drowsiness, and acceptable mobility levels. Therefore, this resulted in incomplete data comparisons of study variables for participan ts in hospital, especially on postoperative day 2. Incomplete data comparisons due to varied discharge days from hospital was a limitation of the study. One purpose of this study was to determine the feasibility of conducting this research in the clinic al setting and into the discharge (home) setting. The majority of p articipants were discharged either home with home health nurse and physical therapy

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139 visitations (n=42, 89%) and a few (n=5, 11%) were discharged to a pre arranged rehabilitation facility for recovery after surgery. In this study, accessing study participants once discharged home or to a rehabilitation facility proved for some, to be difficult In some instances (n=10, 21%) participants could not be contacted at the telephone number give n to the investigator at the preoperative c linic visit in order to conduct the telephone interview on discharge day 3. Als o, in several instances (n=25, 53%), participants did not return their discharge booklets with documented study data as requested. Fortunately, study data from discharge booklets could be obtained during the telephone interview with participa nts. Not being able to access study participants via telephone for interview and not receiving data booklets once discharged from hospital resul ted in incomplete data for some participants and was a limitation of the study. Fidelity to music listening was not examined in this study. Whether music group participants truly listened to music for the frequency and duration instructed was not verifi ed beyond reviewing documentation received from these participants and conversation s with them by the study investigator. Further, control group participants refraining from listening to music in hospital and post discharge was not verified in the study beyond conversations with them by the study investigator. Lack of verification of fidelity to music listening the study intervention, was a limitation of the study. Only orthopedic patients undergoing joint replacement surgery (e ither knee or hip joint replacement surgery) were chosen for inclusion in this study. Therefore, the generalizability of results of this study is limited to patients undergoing these types of

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140 orthopedic surgery. Generalizability of study findings was ano ther limitation of the study. Implications for Education Educat ing p atients on the u se of m usic in addition to opioid and non opioid analgesic usage, would enhance acute surgical pain management with patients in both the hospital and discharge (home) set tings. A t required group preoperative information sessions and at preoperative clinic visits, patients should be educated about the potential benefits of music in reducing pain, and encourage d to bring a device for music listening with them to hospital and use it at home. Educat ing n urse m anagers, n ursing s taff, n urse e ducators, and n ursing s tudents on u se of m usic in order to implement evidence based practice is necessary to help patients achieve positive surgical outcomes. Such information sharing can occur during nursing team meetings, brown bag lunches, classroom discussions or other such sessions, in order to inform nurses of the importance of offering music as an adjuvant, along with a nalgesic medications to enhance postoperative pain management with surgical patients in the hospital and discharge ( home ) settings. Implications for Practice Nurs es are to base their professional practice on sound evidence from sources such as clinical research, and it is belie ved that such evidence helps nurses to make appropriate, cost effective, and efficacious decisions for good client outcomes (Polit, 2010). This research study examined the use of music listening to enhance acute surgical pain management with patients who had undergone orthopedic surgery, specifically knee and hip joint arthroplasty surgery, and provides empirical e vidence indicating that music is an effective adjuvant, along with analgesic medications in

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141 reducing acute postoperative pain. This empirica l evidence provides support for nurses to recommend music for acute surgical pain management with patients undergoing orthopedic surgery. In addition to administering analgesic medications to help control acute pain after surgery, encouraging music as an in tervention for s urgical patients can improve pain management outcomes This intervention is low cost, portable, and easily accessible to patients who own a smart phone or tablet. Before surgery at their group pre operative information session held at the Orthopedic Clinic patients should be educated about the potential benefits of music in reducing pain and encourage d to bring a device for music listening with them to hospital. In the hospital setting, clinicians and ma nagers should conside r having low cost device s available for use by patients who to do not have one. Further, patients should be encouraged to continue to use music listening, along with analgesic medications for pain control once discharged home. A challenge for nurses is to help manage pain with patients at times when it is exacerbated during pain provoking but clinically necessary maneuvers; for example, during dressing changes with burn patients, range of motion exercises or ambulation efforts with joint replacement pat ients, and during deep breathing and controlled coughing exercises with thoracotomy patients. Development of p rotocols that use music to help relieve pain provoking clinical maneuvers would be beneficial to patients in the clinical setting. Nurses should participate in developing evidence based music listening programs Nursing Practice C ommittees can examine the measures needed to implement music listening in the practice setting with patients. In the clinical agency

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142 where this study was conducted, a n A rts in Medicine Program exists, and includes art therapy services provided by professionals specifically trained to facilitate, for example, Music Therapy with patients in hospital. The Nursing Practice Committee in this clinical agency can team up with t hese professionals to develop an evidence based program for patients hospital wide, or for patients experiencing specific illnesses or surgeries. P rograms can continue to be implemented with patients after discharge from hospital to home and supervised by clinicians who see patients in their home environment for rehabilitation; for example, the homecare nurse and physical thera pist. This is the future direction that music use with patients after surgery is heading, as orthopedic joint replacement surgery is now being performed as same day surgery for some candidates. Implications for Research This stud y is the first randomized trial to examine the use of music listening for acute surgical pain management with orthopedic patients beyond the hospit al setting. There were a number of limitations of this study, and challenges with implementing it in both the hospital and discharge settings. Changes discussed in the strengths and limitations section above would strengthen the study power and improve t he statistical conclusion validity of the study findings. Future research should focus on and include designs of randomized trials with adequate sample sizes and statistical power to strengthen statistical conclusion validity. Barriers to implementing the study intervention was a challenge in this study. In future studies, music group participants could be instructed to use ear pieces or headphones with their internet access device when listening to music thereby eliminating the noise of the hospital environment. With implementation of a music therapy program, health care providers on the unit would more likely facilitat e music

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143 listening by keeping interruptions with participants to a minimum at music listening times. Lack of verification of fidelity to music listening was an issue in this study. In future studies, measures to verify fidelity to music listening need to be included in the study design. This could include having a research assistant present in hospital during stay, and having the Home Care Nurse and Physical Therapist who visit participants at home to carry out rehabilitation therapy continue music listening verification. Lack of measurement of analgesic usage prior to music listening or scheduled mealtimes with study participants was an issue in this study. In future studies time since last analgesic dosing as well as drug type and dose received need to be examined for their effects on the major study variables. Incomplete data due to varied d ischarge days from hospita l was an issue in this study. In future studies, c hanges to data collection measurement points would need to be instituted to reflect times patients now stay in hospital after orthopedic joint arthroplasty surgery. Some patients undergo orthopedic surgery for joint arthroplasty during same day surgery. This supports the need for patient education discharge instructions to include use of music for pain management in the home setting. Incomplete data due to contact and mail ret urn problems post discharge was an issue in this study. In future studies, contact with study participants once discharged home could include daily telephone calls on discharge days 1 and 2 for the study investigator to review same day log booklet entries and for the treatment group, use of music listening. This strategy would decrease participant recall bias. Follow up

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144 reminder postcards could be mailed to study participants if telephone contact or mail return of log booklets were delayed. As an incen tive to maintain follow up contact, study participants could be offered monetary Visa gift cards for completion of telephone interviews and return of study log booklets. Also, on line survey templates to collect study data might be an option with study pa rticipants, but participants would need to have internet access available. In addition to data collection issues, there were issues in this study with measurement timing and dosing of the music listening intervention with study participants M usic grou p participants were instructed, per the study protocol, to listen to music for 30 minutes duration, three times a day when they were experiencing pain after surgery both in hospital (evening of surgery, postoperative days 1 and 2) and when discharged from hospital (discharge days 1 and 2). During the evening of surgery, some participants were not experiencin g pain due to the presence of the anesthetic nerve block. Therefore, in future studie s, evening of surgery as the beginning measurement time period m ay not be appropriate for patients who have nerve blocks in place postoperatively Anesthetic nerve block was typically removed with study participants the morning o n postoperative day one in hospital In future studies, better tim ing to be gin implementing the study intervention and begin study measurements (after nerve block removal) would decrease the incidence of missing data the evening of surgery (first measurement period in hospital) and the morning of postoperative day 1 (se cond measurement period in hospital). The inclusion of vulnerable populations such as the critically ill, the very young and old, and the cognitively impaired would help identify strategies for implementing

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145 music therapy with individuals who e xperience but cannot verbally communicate their pain. This should be a focus of future studies. What are the optimal multimodal combinations (pharmacological and non pharmacological) for effectively managing acute postoperative pain with patients after surgery? These combinations need to be empirically examined in order to identify those combinations that are most effective for specific surgical patient populations. Nurses can collaborate with physicians to help determine s uch evidence generation that would in turn inform clinical practice guidelines for acut e postoperative pain management (Chou et al, 2016). Conclusions Effective acute surgical pain management is important to both clinicians and patients. Clinical practice guidelines such as those pub lished by the American Pain Society ( Chou et al. 2016) and Agency for Healthcare Research and Quality (AHRQ) (Carr & Jacox, 2006) advocate for the use of evidence based non pharmacological interventions such as music to help achieve optimal pain managemen t with patients following surgery. The results of this study lend further evidence to support the use of music listening, along with prescribed analgesic medications, to enhance acute surgical pain management following joint arthroplasty surgery. Despite the study limitations, results indicated pa rticipants who used music listening after surgery for ap proximately 30 minutes up to three times per day along with analgesic medications, reported significant reductions in pain intensity and pain distr ess compared to participants who used analgesics alone. Further, these results provide support for the use of music in both the hospital and post discharge (home) settings.

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146 Professional n urse s are the health care provider s who spend the most time w ith postoperative patient s. Thus, they are in the ideal position to offer and implement supportive interventions to help enhance postoperative pain management. Music is a non invasive, s afe, and inexpensive interventio n that can be delivered easily and s uccessfully with patients in both the hospital and home settings. S ufficient researc h has been conducted to indicate that music should be made available to all patients un dergoing operative procedures (Chou et al., 2016). Implementing music listening fo r pain relief with patients after surgery can be considered an evidence based nursing practice.

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147 APPENDIX A DEMOGRAPHICS SHEET Acute Surgical Pain Management Study PARTICIPANT DEMOGRAPHIC DATA SHEET Q. 1. What is your sex? 1. Male 2. Female Q. 2. What is your age? ( In years): ________ Q. 3. What is your marital status? 1. Married 3. Divorced/separated 2. Widowed 4. Never married Q.4. What is your race? 1. White 4. Asian 2. Black or African American 5. Native Hawaiian/Other Pacific Islander 3. Native American/Native Alaskan 6. Other Q. 5. What is the highest grade of school that you completed? 1. 8 th grade or less 4. Some college or vocational school 2. Some high school 5. College graduate 3. High school Diploma or GED 6. Post graduate/professional Q. 6. Do you have any concurrent acute or chronic pain conditions? If yes, how many? 1. None 3. 2 3 conditions 2. 1 condition 4. 4 or more conditions

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148 APPENDIX B BOOKLETS: MUSIC GROUP: HOSPITAL & DISCHARGE USE OF MUSIC LISTENING TO ENHANCE ACUTE SURGICAL PAIN MANAGEMENT WITH PATIENTS UNDERGOING ORTHOPEDIC SURGERY Hospital Log Booklet Music Group Participants Dear Music Group Participant: If you have any questions or concerns, please contact: Study Co Investigator: Joanne Laframboise Otto, MSN, RN, at (352) 222 0374 Or her supervisor: Dr. Ann Horgas at (352) 273 7622

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149 We hope you are having an uneventful and speedy recovery from your surgery. It is important that you listen to your preferred music for 30 minutes at least three times a day to help relieve your pain after surgery. You are encouraged to listen to music in addition to taking your prescribed pain medication to relieve your surgical pain. Please remember, study staff have asked that you write down in this booklet the following information: 1. music listening ( times during the day and duration of each music listening session) 2. pain intensity and pain distress ratings before and after music listening 3. pain medication taken throughout the day (drug, dose. route, time taken) 4. pain intensity and pain distress ratings before and about 30 minutes after pain medication taken 5. int ensity of side effects (if any) experienced (specifically nausea and drowsiness) S tudy staff will visit you postoperatively on your day of surgery and call or visit you on your first and second postoperative days, asking you about your music listening p ain pain medication taken and side effects It will be easier to write this information in this booklet throughout day rather than to try to remember it later when study staff call or visit. Remember t o give your completed hospital log booklet to nursing staff on the day you are discharge d from the hospital. Your booklet will be given to Study staff. Acute Surgical Pain Management Study Numerical Rating Scales Pain Intensity:

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150 Num erical Rating Scales Pain Intensity: 0____1____2____3____4____5____6____7____8____9____10 No Pain Worst Pain Imaginable Pain Distress: 0____1____2____3____4____5____6____7____8____9____10 No Distress Worst Distress Imaginable Nausea Intensity: 0____1____2____3____4____5____6____7____8____9____10 No Nausea Worst Nausea Imaginable Drowsiness Intensity: 0____1____2____3____4____5____6____7____8____9____10 No Dro wsiness Worst Drowsiness Imaginable

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151

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152 Thank you for participating in the music study while you were in hospital. Remember to give this booklet to nursing staff when you are discharged from hospital. We will be in touch by telephone on the 3 rd day you are discharged.

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153 USE OF MUSIC LISTENING TO ENHANCE ACUTE SURGICAL PAIN MANAGEMENT WITH PATIENTS UNDERGOING ORTHOPEDIC SURGERY Discharge Log Booklet Music Group Participants If you have any questions or concerns, please contact: Study Co Investigator: Joanne Laframboise Otto, MSN, RN at (352) 222 0374 Or her supervisor: Dr. Ann Horgas at (352) 273 7622

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154 Dear Music Group Participant: We hope you are having a comfortable stay now that you have been discharged from hospital. It is important that you continue to use your preferred music for 30 minutes at least three times a day when discharged to help relieve your pain after surgery. You are encouraged to listen to music in addition to taking your prescribed pain medication to relieve your surgical pain when discharged. Please remember, study staff ha ve asked that you write down in this booklet the following information: 1. music listening (three times each day and duration of each music listening session) 2. pain intensity and pain distress ratings before and after music listening 3. pain medication taken throughout the day (drug, dose, time taken) 4. pain intensity and pain distress ratings before and about 30 minutes after pain medication taken 5. t he intensity of side effects (if any) experienced (specifically nausea and drowsiness) S tudy staff will be calling you on the 3rd day you are discharged asking you about your music listening pain pain medication taken and side effects in order to complete the study. It is easier to write this information down each day rather than to try to remember it later when study staff call. Remember to mail via USPS, in the stamped, self addressed no return address envelope provided to you in h ospital prior to your discharge, your discharge log booklet mailing it to study co investigator Ms. Joanne Laframboise Otto, MSN, RN.

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155 Numerical Rating Scales Pain Intensity: 0____1____2____3____4____5____6____7____8____9____10 No Pain Worst Pain Imaginable Pain Distress: 0____1____2____3____4____5____6____7____8____9____10 No Dis tress Worst Distress Imaginable Nausea Intensity: 0____1____2____3____4____5____6____7____8____9____10 No Nausea Worst Nausea Imaginable Drowsiness Intensity: 0____1____2____3____4____5____6____7____8____9____10 No Drowsiness Worst Drowsiness Imaginable

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156

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157 Thank you for participating in the music study while you were discharged. Remember to mail this booklet in the stamped, pre addressed, no return address envelope provided to you. We wish you continued recovery from your surgery.

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158 APPENDIX C BOOKLETS: CONTROL GROUP : HOSPITAL & DISCHARGE USE OF MUSIC LISTENING TO ENHANCE ACUTE SURGICAL PAIN MANAGEMENT WITH PATIENTS UNDERGOING ORTHOPEDIC SURGERY Hospital Log Booklet Control Group Participants If you have any questions or concerns, please contact: Study Co Investigator: Joanne Laframboise Otto, MSN, RN, at (352) 222 0374 Or her supervisor: Dr. Ann Horgas at (352) 273 7622

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159 Dear Control Group Participant: We hope you are having an uneventful and speedy recovery from your surgery. You are encouraged to take your prescribed pain medication in order to relieve your pain after surgery. While you are in hospital, we ask that you not listen to music during your hospital stay. Please remember, study staff ha ve asked that you write down in this booklet the following information: 1. pain intensity and pain distress ratings before and after hospital scheduled mealtimes 2. pain medication you receive throughout the day (drug, dose, route, & time taken) 3. pain intensity and pain distress ratings before and about 30 minutes after pain medication taken 4. intensity of side effects (if any) experienced (specifically nausea and drowsiness) S tudy staff will visit you postoperatively on your day of surgery and either visit or call you on your first and second postoperative days asking you a bout your pain pain medication taken and side effects It will be easier to write this information in this booklet throughout day rather than to try to remember it later when study staff call or visit. Remember to give your completed hospital log booklet to nursing staff the day you are discharge d from the hospital. Your booklet will be given to Study staff.

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160 Numerical Rating Scales Pain Intensity: 0____1____2____3____4____5____6____7____8____9____10 No Pain Worst Pain Imaginable Pain Distress: 0____1____2____3____4____5____6____7____8____9____10 No Distress Worst Distress Imaginable Nausea Intensity: 0____1____2____3____4____5____6____7____8____9____10 No Nausea Worst Nausea Imaginable Drowsiness Intensity: 0____1____2____3____4____5____6____7____8____9____10 No Drowsiness Worst Drowsiness Imaginable

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162 Thank you for participating in the music study while you were in hospital. Remember to give this booklet to nursing staff when you are discharged from hospital. We will be in touch by telephone on the 3 rd day you are discharged.

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163 USE OF MUSIC LISTENING TO ENHANCE ACUTE SURGICAL PAIN MANAGEMENT WITH PATIENTS UNDERGOING ORTHOPEDIC SURGERY Discharge Log Booklet Control Group Participants If you have any questions or concerns, please contact: Study Co Investigator: Joanne Laframboise Otto, MSN, RN, at (352) 222 0374 Or her supervisor: Dr. Ann Horgas at (352) 273 7622

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164 Dear Control Group Participant: We hope you are having a comfortable stay now that you have been discharged from hospital. You are encouraged to take your prescribed pain medication to relieve your surgical pain as you did when you were in hospital. Just like when you were in hospital, we ask that you not listen to music during the first two days you are discharged. Please remember, study staff ha ve asked that you write down in this booklet the following information: 1. pain intensity and pain distress ratings around common meal times: breakfast, lunch, and dinner 2. pain medication you take throughout the day (drug, dose, time taken) 3. pain intensity and pain distress ratings before and about 30 minutes after pain medic ation taken 4. the intensity of side effects (if any) experienced (specifically nausea and drowsiness) S tudy staff will be calling you on the 3rd day you are discharged asking you about your pain pain medication taken and side effects in order to compl ete the study. It is easier to write this information down each day rather than to try to remember it later when study staff call. Remember to mail via USPS, in the stamped, self addressed no return address envelope provided to you in hospital prior to y our discharge, your discharge log booklet mailing it to study co investigator Ms. Joanne Laframboise Otto, MSN, RN.

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165 Numerical Rating Scales Pain Intensity: 0____1____2____3____4____5____6____7____8____9____10 No Pain Worst Pain Imaginable Pain Distress: 0____1____2____3____4____5____6____7____8____9____10 No Dis tress Worst Distress Imaginable Nausea Intensity: 0____1____2____3____4____5____6____7____8____9____10 No Nausea Worst Nausea Imaginable Drowsiness Intensity: 0____1____2____3____4____5____6____7____8____9____10 No Drowsiness Worst Drowsiness Imaginable

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167 Thank you for participating in the music study while you were discharged. Remember to mail this booklet in the stamped, pre addressed, no return address envelope provided to you. We wish you continued recovery from your surgery.

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168 APPENDIX D SURVEYS: MUSIC LISTENING & OVERALL PAIN EXPERIENCE MUSI C LISTENING EXPERIENCE AFTER SURGERY SURVEY (Experimental Group Participants) Please rate the following statements in terms of your experience with music listening after surgery 1. The music I chose to listen to after surgery was a good choice for me. Strongly agree Agree Neither Agree nor Disagree Disagree Strongly Disagree 2. The music I listened to helped to reduce my pain after surgery. Strongly agree Agree Neither Agree nor Disagree Disagree Strongly disagree 3. The music I listened to helped to reduce my anxiety after surgery Strongly agree Agree Neither Agree nor Disagree Disagree Strongly disagree 4. The pain medication I received worked well with my music to help reduce my pain after surgery. Strongly agree Agree Neither Ag ree nor Disagree Disagree Strongly disagree 5. I would recommend music listening to other patients after surgery. Strongly agree Agree Neither Agree nor Disagree Disagree Strongly disa gree What suggestions do you have for improving your music listening experience after surgery ? ______________________________________________ ________________________ ______________________________________________ ________________________ _____________________________________________ ________________________

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169 OVERALL PAIN EXPERIENCE IN HOSPITAL AFTER SURGERY SURVEY (All Participants) Please rate the following statements in terms of your pain experience in hospital after surgery. 1. My pain in hospital after surgery was what I expected. Strongly agree Agree Neither Agree nor Disagree Disagree Strongly Disagree 2. The intensity of my pain in hospital after surgery was well controlled Strongly agree Agree N either Agree nor Disagree Disagree Strongly disagree 3. The distress I experienced from my pain in hospital after surgery was well controlled. Strongly agree Agree Neither Agree nor Disagree Disagree Strongly disagree 4. The side effects from pain medication that I received in hospital after surgery were well controlled. Strongly agree Agree Neither Agree nor Disagree Disagree Strongly disagree 5. The pain medication I received in hospital after surgery worked well to control my pain. Strongly agree Agree Neither Agree nor Disagree Disagree Strongly disagree What suggestions do you have for improving your overall pain experience in hospital after surgery ? ______________________________________________ ________________________ _____________________________________________ ________________________

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170 APPENDIX E EPIC DATA SHEET: PAIN REPORTS TO NURSES & PAIN MEDS IN HOSPITAL

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171 APPENDIX F STATE ANXIETY INVENTORY (FORM Y 1) (SAMPLE USED WITH PERMISSION )

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175 Good, M., Stanton Hicks, M., Grass, J., Cranston Anderson, G., Choi, C., Schoolmeesters, L. & Salman, A. (1999). Relief of postoper ative pain with jaw relaxation, music and their combination. Pain, 81, 163 172. Good, M., Stiller, C., Zauszniewski, J., Anderson, G., Stanton Hicks, M., & Grass, J. (2001). Sensation and distress of pain scales: Reliability, validity, and sensitivity. Journal of Nursing Measurement, 9 219 238. Gooding, L., Swezey, S., & Zwischenberger, J. (2012). Using music interventions in perioperative care. So uthern Medical Journal, 105, 486 490. Gordon, D., de Leon Casasola, O., Wu, C., Sluka, K., Brennan, T. & Chou, R. (2016). Research gaps in Practice Guidelines for Acute Postoperative Pain Management in Adults: Findings from review of the evidence for an American Pain Society Clinical Practice Guideline. The Journal of Pain, 7, 158 166. Harlocker, T. (2010). Pain management in total joint arthroplasty: a historical review. Orthopedics, 33 14 19. Hole, J., Hirsch, M., Ball, E. & Meads, C. (2015). Music as an aid for postoperative recovery in adults: a systematic review and meta analysis. The Lancet, 386 1659 1671. Ignacio, J., Chan, M., Teo, S., Tsen, L. & Goy, R. (2012). Research in brief The effect of music on pain, anxiety, and analgesic use on adults undergoing an orthopedic surgery: A pilot study. Singapore Nursing Journal, 39 49 51. Johnson, J. (1973). Effects of accurate expectations about sensations on the sensory and distress components of pain. Journal of Personality and Soc ial Psychology, 20, 55 64. Joint Commission for the Accreditation of Healthcare Organizations, Improving the Quality of Pain Management through Measurement and Action. Accessed at: www.jcaho.org. Jose, J., Verma, M. & Arora, S. (2012). An experimenta l study to assess the effectiveness of music therapy on the postoperative pain perception of patients following cardiac surgery in a selected hospital in New Delhi. International Journal of Nursing Education, 4, 198 201. Labraca, N., Castro Sanchez, A., Mataran Penarrocha, G., Arroyo Morales, M., Sanchez Joya, M. & Moreno Lorenzo, C. (2011). Benefits of starting rehabilitation within 24 hours of primary total knee arthroplasty: randomized clinical trial. Clinical Rehabilitation, 25, 557 566. Lin, P. (2 011). An evaluation of the effectiveness of relaxation therapy for patients receiving joint replacement surgery. Journal of Clinical Nursing, 21 601 608.

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176 Lin, P., Lin, M., Huang, L., Hsu, H., & Lin, C. (2011). Music therapy for patients receiving sp inal surgery. Journal of Clinical Nursing, 20 960 968. Liu, Y., & Petrini, M. (2015). Effects of music therapy on pain, anxiety, and vital signs in patients after thoracic surgery. Complementary Therapy in Medicine, 23 714 718. Madson, A., & Silverman, M. (2010). The effect of music therapy on relaxation, anxiety, pain perception, and nausea in adult solid organ transplant patients. Journal of Music Therapy, 47, 220 232. Matsota, P., Christodoulopoulou, T., Smyrnioti, M., Pandazi, A., Kanel lopoulos, I., anesthesia and analgesia. The Journal of Alternative and Complementary Medicine, 19, 298 307. McCaffery, R. & Good, M. (2000). The lived experience of listening t o music while recovering from surgery. Journal of Holistic Nursing, 18 378 390. McCarthy, M., Chang, C., Pickard, A., Giobbie Hurder, A., Price, D., Jonasson, O., Gibbs, J., Fitzgibbons, R., & Neumayer, L. (2005). Visual analog scales for assessing surgical pain. Journal of the American College of Surgeons, 201 245 252. Melzack, R., & Wall, P. (1996). Pain mechanisms: A new theory. Pain Forum, 5 3 11. Melzack, R., & Wall, P. (1965). Pain mechanisms: A new theory Science, 150 971 979. Mo ndanaro, J., Homel, P., Lonner, B., Shepp, J., Lichtensztejn, M. & Loewy, J. (2017). Music therapy increases comfort and reduces pain in patients recovering from spine surgery. The American Journal of Orthopedics, 1 E13 E22. Nilsson, U. (2008). The anxiety and pain reducing effects of music interventions: a systematic review. AORN J, 87 780 807. Ozer, N., Karaman Ozlu, Z., Arslan, S., & Gunes, N. (2013). Effect of music on postoperative pain and physiologic parameters of patients after o pen heart surgery. Pain Management Nursing, 14, 20 28. Phumdoung, S. & Good, M. (2003). Music reduces sensation and distress of labor pain. Pain Management Nursing, 4, 54 61. Polit, D. (2010). Statistics and data analysis for nursing research (2 nd Ed.). Upper Saddle River, NJ: Pearson. Polit, D. & Beck, C. (2008). Nursing research: Generating and assessing evidence for nursing practice (8 th Ed.). Philadelphia: Lippincott Williams & Wilkins.

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178 BIOGRAPHICAL SKETCH Joanne Margaret Laframboise Otto was born in Chatha m, Ontario, Canada. She began her career in nursing after graduating from the University of Western Ontario, London, Canada in 1982 with a Bachelor of Science in Nursing (BScN). Her first clinical position was at Sunnybrook Medical Center in Toronto, Ont ario in the clinical specialty of n eurosurgery nursing. Shortly after graduating, and kno wing that she wanted to teach nursing, she returned to Western to complete her Master of Science in Nursing (MScN) in 1987. She was hired at Western University to teach fundamentals and medical surgical nursing in the baccalaureate nursing program. She taught at Western University from 1987 until 1994, holding positions of Clinical Instructor, Lecturer, and Assistant Professor in the Faculty of Nursing. Always int erested in pursuing higher education, she left Ontario C anada to come to Florida having been accepted into the PhD in Nursing Science s Program at the University of Florida in the f all 1994. Working part time at Shands Hos pital in the Medical ICU and lat er in Central Staffing Office, she continued her PhD studies part time for several years During this time s he worked as a Teaching Assistant and Research Assistant in the College of Nursing at UF Life has a way of interjecting and she met her husband Bruce and later married in December 2000. Shortly afterwards, they welcomed their son Eddie into the world, with Eddie being born at Shands Hospital in Gainesville, FL in 2001. She took a short leave from her PhD studies at UF to pursue full time teach ing employment at the rank of Assistant Professor at Santa Fe College in Gainesville, FL, and later continued full time employment as a Professor of Nursing at Florida Gateway College in Lake City, FL. After completing her PhD in Nursing Science s at UF in December 2017, she plans to continue tea ching and begin a trajectory of research following her dissertation work.