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Nonnutritive Sucking and Sucrose-Induced Analgesia

Permanent Link: http://ufdc.ufl.edu/UFE0024352/00001

Material Information

Title: Nonnutritive Sucking and Sucrose-Induced Analgesia Effect on Heart Rate, Oxygen Saturation, and Pain in Intubated Infants
Physical Description: 1 online resource (142 p.)
Language: english
Creator: Miller, Harriet
Publisher: University of Florida
Place of Publication: Gainesville, Fla.
Publication Date: 2009

Subjects

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

Notes

Abstract: Critically ill neonates who require artificial airways are unable to vocalize due to the blocking of their vocal chords by the endotracheal tube. Pain assessment in this neonatal population is difficult due to the inability of the infants to self-report their pain with cries of distress. While pain is a common part of the hospital experience, nonnutritive sucking-induced analgesia with sucrose is offered less to intubated neonates. The purpose of this study was to determine the effect of nonnutritive sucking (NNS) combined with sucrose-induced analgesia on heart rate, oxygen saturation, and pain behaviors as measured by the Neonatal Infant Pain Scale (NIPS) in intubated infants. Using a repeated measures cross-over design, 14 infants between the ages of 32 and 42 weeks were sampled by convenience from a Neonatal Intensive Care Unit. Each infant served as it?s own control, and were randomly assigned to participate first in one of two conditions resulting in 28 observations. In the treatment condition infants were offered NNS with sucrose, and in the control condition were not. Heart rate and oxygen saturation were measured in 30-second intervals during a 5-minute baseline period, a heel stick, and 5-minute follow-up period. Pain behaviors were measured in one minute intervals. Findings were analyzed using a within-subjects repeated measures analysis of variance. Significant differences were noted between the control and intervention conditions. Heart rate significantly increased following the heel stick in the control condition; main effect F (df 1, 13) = 46.65, p < .001; phase effect F (df 3, 39) = 101.73, p < .001; interaction effect F (df 3, 39) = 24.69, p < .001. Oxygen saturation significantly decreased following the heel stick in the control condition; main effect F (df 1, 13) = 19.08, p = .001; phase effect F (df 3, 39) = p < .001; interaction effect F (df 3, 39) = p < .001. The NIPS Score significantly increased following the heel stick in the control condition; phase effect F (df 1, 13) = 697.88, p < .001. Findings will be used to further knowledge related to pain in intubated infants in the hospital setting.
General Note: In the series University of Florida Digital Collections.
General Note: Includes vita.
Bibliography: Includes bibliographical references.
Source of Description: Description based on online resource; title from PDF title page.
Source of Description: 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.
Statement of Responsibility: by Harriet Miller.
Thesis: Thesis (Ph.D.)--University of Florida, 2009.
Local: Adviser: Krueger, Charlene.

Record Information

Source Institution: UFRGP
Rights Management: Applicable rights reserved.
Classification: lcc - LD1780 2009
System ID: UFE0024352:00001

Permanent Link: http://ufdc.ufl.edu/UFE0024352/00001

Material Information

Title: Nonnutritive Sucking and Sucrose-Induced Analgesia Effect on Heart Rate, Oxygen Saturation, and Pain in Intubated Infants
Physical Description: 1 online resource (142 p.)
Language: english
Creator: Miller, Harriet
Publisher: University of Florida
Place of Publication: Gainesville, Fla.
Publication Date: 2009

Subjects

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

Notes

Abstract: Critically ill neonates who require artificial airways are unable to vocalize due to the blocking of their vocal chords by the endotracheal tube. Pain assessment in this neonatal population is difficult due to the inability of the infants to self-report their pain with cries of distress. While pain is a common part of the hospital experience, nonnutritive sucking-induced analgesia with sucrose is offered less to intubated neonates. The purpose of this study was to determine the effect of nonnutritive sucking (NNS) combined with sucrose-induced analgesia on heart rate, oxygen saturation, and pain behaviors as measured by the Neonatal Infant Pain Scale (NIPS) in intubated infants. Using a repeated measures cross-over design, 14 infants between the ages of 32 and 42 weeks were sampled by convenience from a Neonatal Intensive Care Unit. Each infant served as it?s own control, and were randomly assigned to participate first in one of two conditions resulting in 28 observations. In the treatment condition infants were offered NNS with sucrose, and in the control condition were not. Heart rate and oxygen saturation were measured in 30-second intervals during a 5-minute baseline period, a heel stick, and 5-minute follow-up period. Pain behaviors were measured in one minute intervals. Findings were analyzed using a within-subjects repeated measures analysis of variance. Significant differences were noted between the control and intervention conditions. Heart rate significantly increased following the heel stick in the control condition; main effect F (df 1, 13) = 46.65, p < .001; phase effect F (df 3, 39) = 101.73, p < .001; interaction effect F (df 3, 39) = 24.69, p < .001. Oxygen saturation significantly decreased following the heel stick in the control condition; main effect F (df 1, 13) = 19.08, p = .001; phase effect F (df 3, 39) = p < .001; interaction effect F (df 3, 39) = p < .001. The NIPS Score significantly increased following the heel stick in the control condition; phase effect F (df 1, 13) = 697.88, p < .001. Findings will be used to further knowledge related to pain in intubated infants in the hospital setting.
General Note: In the series University of Florida Digital Collections.
General Note: Includes vita.
Bibliography: Includes bibliographical references.
Source of Description: Description based on online resource; title from PDF title page.
Source of Description: 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.
Statement of Responsibility: by Harriet Miller.
Thesis: Thesis (Ph.D.)--University of Florida, 2009.
Local: Adviser: Krueger, Charlene.

Record Information

Source Institution: UFRGP
Rights Management: Applicable rights reserved.
Classification: lcc - LD1780 2009
System ID: UFE0024352:00001


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1 NONNUTRITIVE SUCKING AND SUCROSE INDUCED ANALGESIA : EFFECT ON HEART RATE, OXYGEN SATURATION, AND PAIN IN INTUBATED INFANTS By HARRIET D. MILLER 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 2009

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2 2009 Harriet D. Miller

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3 To my parents, Mildred Dean Miller and Fred Eaves Miller, Jr., and mentors D r. Josephine Snider, and Dr. Sandra Seymour

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4 ACKNOWLEDGMENTS I would like to thank my supervisory committee for their guidance and support in assisting to build a framework for the study and seeing it through until completion. This also includes Profe ssors Jodi Irving, Dr. Mary Lou Sole, Dr. Gale Danek, and Dr. Gene Anderson who first supported my desire to examine infant pain. Secondly, I would like to thank the staff at Winnie Palmer Hospital for Women and Babies including Louise Kaigle, Patrice Hat cher, and Ann Diaz for their continual encouragement. In addition, I would like to thank my family, friends and colleagues through the years for their support. This includes Dr. Patricia Robinson for her unending belief, love, and understanding. Lastly my sincere appreciation goes to the parents of the infants who consented to participate in this study, and of course, to the infants themselves for the observation of their behavior. primum non nocere

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5 TABLE OF CONTENTS page ACKNOWLEDGMENTS .................................................................................................................... 4 LIST OF TABLES ................................................................................................................................ 8 LIST OF FIGURES ............................................................................................................................ 10 ABSTRACT ........................................................................................................................................ 12 CHAPTER 1 INTRODUCTION ....................................................................................................................... 14 Immediate Responses (Physiological and Behavioral) ............................................................. 14 Long Term Responses to Pain (Physiological and Behavioral) ............................................... 15 Application to Nursing ................................................................................................................ 16 Specific A ims .............................................................................................................................. 18 Specific Aim 1 ..................................................................................................................... 18 Hypothesis 1 ......................................................................................................................... 18 Specific Aim 2 ..................................................................................................................... 18 Hypothesis 2 ......................................................................................................................... 19 Specific Aim 3 ..................................................................................................................... 19 Hypothesis 3 ......................................................................................................................... 19 2 REVIEW OF LITERATURE ..................................................................................................... 20 Bioethical Codes ......................................................................................................................... 20 Four Principles of Bioethics ................................................................................................ 21 Caring ................................................................................................................................... 22 Medical and Nursing Principles Related to Pain ............................................................... 23 Applicati on to Pediatrics ..................................................................................................... 24 Pain ............................................................................................................................................... 26 Gate Control Theory ............................................................................................................ 26 Level of Theo ry ................................................................................................................... 28 Relational Statements of the Gate Control Theory ............................................................ 29 Theoretical Assumptions of the Gate Control Theory ...................................................... 30 Pain in Infants ...................................................................................................................... 31 Interventions to Treat Infant Pain ....................................................................................... 33 Bioethics and Infant Pa in ............................................................................................................ 36 Considerations in Nursing ................................................................................................... 36 Factors Impacting Nursing Assessment of Pain ................................................................ 37 Medical Diagnosis ............................................................................................................... 37 Infants Behavior, Expression, and Physiology ................................................................. 38 Infant Age ............................................................................................................................. 38 Parental Participation ........................................................................................................... 39

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6 Nurse Knowledge, Work Experience, and Attitude. ......................................................... 39 Nurses Work load ................................................................................................................ 41 Toward an Effective Assessment of Pain in Infants .......................................................... 42 Summary ...................................................................................................................................... 44 3 METHODS .................................................................................................................................. 47 Design .......................................................................................................................................... 47 Subjects and Setting .................................................................................................................... 47 Power Ana lysis ............................................................................................................................ 47 Variables ...................................................................................................................................... 48 Independent Variable ........................................................................................................... 48 Dependent Variable ...................................................................................................... 49 Heart Rate ..................................................................................................................... 49 Oxygen Saturation ............................................................................................................... 49 NIPS Behavioral Pain Scal e ................................................................................................ 49 Painful Event ............................................................................................................................... 51 Procedure ..................................................................................................................................... 51 Treatment Condition ............................................................................................................ 52 Control Condition ................................................................................................................ 52 Risks and Benefits ............................................................................................................... 52 Data Analysis ............................................................................................................................... 53 Hypothesis 1 ......................................................................................................................... 53 Hypothesis 2 ......................................................................................................................... 53 Hypothesis 3 ......................................................................................................................... 54 4 RESULTS .................................................................................................................................... 58 Sample .......................................................................................................................................... 58 Participant Demographics ........................................................................................................... 58 Observations ......................................................................................................................... 59 Heart Rate ............................................................................................................................. 59 Oxygen Saturation ............................................................................................................... 59 NIPS Scores ......................................................................................................................... 60 Results .......................................................................................................................................... 60 Visual Analyses ................................................................................................................... 60 Aggrega ted Data Analyses .................................................................................................. 60 Heart Rate .................................................................................................................................... 61 ANOVA Results .................................................................................................................. 62 ANOVA Interp retation ........................................................................................................ 62 Experimental Effects (Heart Rate) ............................................................................................. 63 Main Effect for EXPCONDITION (Heart Rate) ............................................................... 63 Main Effect for PHASE (Heart Rate) ................................................................................. 63 Interaction Effect: EXPCONDITION*PHASE (Heart Rate) ........................................... 63 Laten cy to Heart Rate Recovery ......................................................................................... 64 Oxygen Saturation ....................................................................................................................... 65 Two Factor Within -Subjects ANOVA ............................................................................... 65

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7 ANOVA Interpretation ........................................................................................................ 65 Experimental Effects (Oxygen Saturation) ................................................................................ 66 Main Effect for EXPCONDITION (Oxygen S aturation) ................................................. 66 Main Effect for PHASE (Oxygen Saturation). .................................................................. 66 Interaction Effect: EXPCONDITION PHASE (Oxygen Saturation) ........................... 67 Latency to Oxygen Saturation Recovery ........................................................................... 68 NIPS Scores ................................................................................................................................. 68 ANOVA Inter pretation ............................................................................................................... 68 Factors that May Mediate the Effect .......................................................................................... 69 Birth Weight ......................................................................................................................... 69 FiO2 ....................................................................................................................................... 69 5 DISCUSSION ............................................................................................................................ 105 Summary .................................................................................................................................... 105 Application ................................................................................................................................ 110 Recommendations ..................................................................................................................... 111 APPENDIX A NEONATAL INFANT PAIN SCALE (NIPS) ....................................................................... 114 B NEONATAL INFANT PAIN SCALE DATA COLLECTION SHEET .............................. 116 C DATA COLLECTION SHEET ............................................................................................... 118 D UNIVERSITY OF FLORIDA INFORMED CONSENT ....................................................... 120 E ORLANDO REGIONAL INFORMED CONSENT .............................................................. 127 LIST OF REFERENCES ................................................................................................................. 134 BIO GRAPHICAL SKETCH ........................................................................................................... 142

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8 LIST OF TABLES Table page 3 1 Inter rater Reliability of Observations .................................................................................. 55 3 2 Treatment Condition Observation for NNS with Sucrose ................................................... 56 3 3 Control Condition Observation for ONNS ........................................................................... 57 4 1 Descr iptive Statistics of Heart Rate ...................................................................................... 70 4 2 Mauchlys Test of Sphericity of Measure: MEASURE 1 ................................................... 70 4 3 Within Subjects Factors of Mea sure: MEASURE 1 ............................................................ 70 4 4 Tests of Within -Subjects Effects Measure: MEASURE 1 .................................................. 71 4 5 Estimates of Measure: MEASURE 1 .................................................................................... 72 4 6 Pairwise Comparisons of Measure: MEASURE 1 ............................................................... 72 4 7 Estimates of Measure: MEASURE 1 .................................................................................... 72 4 8 Pairwise Comparisons ............................................................................................................ 72 4 9 ExpCondition Phase Measure: Oxygen Saturation ........................................................... 73 4 10 Descriptive Statistics of Oxygen Saturation ......................................................................... 74 4 11 Mauchlys Test of Sphericity Measure: Oxygen Saturation ............................................... 74 4 12 Tests of Within -Subjects Effects M easure: Oxygen Saturation .......................................... 75 4 13 Measure: Oxygen Saturation ................................................................................................. 76 4 14 Pairwise Comparisons Measure: Oxygen Saturation ........................................................... 76 4 15 Estimates Measure: Oxygen Saturation ................................................................................ 76 4 16 Pairwise Comparisons Measure: Oxygen Saturation ........................................................... 76 4 17 ExpCondition Phase Measure: Oxygen Saturation ........................................................... 77 4 18 Descriptive Statistics of NIPS Scores ................................................................................... 77 4 19 Mauchlys Test of Sphericity ................................................................................................ 78 4 20 Tests of Within -Subjects Effects Measure: NIPS Score ...................................................... 79

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9 4 21 Characteristics of Race .......................................................................................................... 97 4 22 Characteristics of Gender ...................................................................................................... 97 4 23 Characteristics of APGAR Scores at 1 minute ..................................................................... 97 4 24 Characteristics of APGAR Scores at 5 minutes ................................................................... 97 4 25 Characteristics of C Section Frequencies ............................................................................. 98 4 26 Demographics of Birth Weight, APGAR Scores, and Ventilator Settings ........................ 98 4 27 Characteristics of Individual Birth Weights ......................................................................... 98 4 28 Characteristics of FiO2 Frequencies ..................................................................................... 99 4 29 Characteristics of IMV Frequencies ..................................................................................... 99 4 30 Characteristics of PEEP Frequencies .................................................................................... 99 4 31 Mean Phase Differences in Infant Heart Rate and Oxygen Saturation in Experimental and Control Conditions ........................................................................................................ 100 4 32 Infan t Heart Rate Recovery ................................................................................................. 101 4 33 Infant Oxygen Saturation Recovery .................................................................................... 103 A 1 Neonatal Infant Pain Scale ................................................................................................... 115

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10 LIST OF FIGURES Figure page 2 1 Concept Map ........................................................................................................................... 46 4 1 Estimated marginal means of measure 1 .............................................................................. 73 4 2 Estimated marginal means of oxygen saturation.................................................................. 77 4 3 Heart rate and oxygen saturation levels for Infant 1 (African-American male, Gestatio nal Age = 41 days; 6 days old). ............................................................................... 80 4 4 Heart rate and oxygen saturation levels for Infant 2 (Hispanic female, Gestational Age = 37 days, 13 days old). ................................................................................................. 81 4 5 Heart rate and oxygen saturation levels for Infant 3 (Caucasian female, Gestational Age = 36 days; 9 days old) .................................................................................................... 82 4 6 Heart rate and oxygen saturation levels for Infant 4 (African -American male, Gestational Age = 32 days; 1 day old). ................................................................................. 83 4 7 Heart rate and oxygen saturation levels for Infant 5 (African-American male, Gestational Age = 34 days; 19 days o ld). ............................................................................. 84 4 8 Heart rate and oxygen saturation levels for Infant 6 (African-American male, Gestational Age 38 days; <1 day old). ............................................................................... 85 4 9 Heart rate and oxygen saturation levels for Infant 7 (Hispanic female, Gestational Age = 38 days; 2 days old). ................................................................................................... 86 4 10 Heart rate and oxygen saturation levels for Infant 8 (Caucasian m ale, Gestational Age = 34 days; 1 day old). ..................................................................................................... 87 4 11 Heart rate and oxygen saturation levels for Infant 9 (Hispanic male, Gestational Age = 37 days, 1 day old). ............................................................................................................. 88 4 12 Heart rate and oxygen saturation levels for Infant 10 (Asian male, Gestational Age = 32 days; 1 day old) ................................................................................................................. 89 4 13 Heart rate and oxygen saturation levels for Infant 11 (Caucasian female, Gestational Age = 33 days; 5 days old). ................................................................................................... 90 4 14 Heart rate and oxygen saturation levels for Infant 12 (Hispanic male, Gestational Age = 32 days; 5 days old). ................................................................................................... 91 4 15 Heart rate and oxygen saturation levels for Infant 13 (African-American female, Gestational Age = 32 days; 1 day old). ................................................................................. 92

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11 4 16 Heart rate and oxygen saturation levels for Infant 14 (Caucasian male, Gestational Age = 36 days; 3 days old). ................................................................................................... 93 4 17 Mean heart rate across control and NNS conditions. ........................................................... 94 4 18 Mean oxygen saturation levels across control and NNS conditions. .................................. 95 4 19 Mean NIP ratings across control and NNS conditions. ....................................................... 96

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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 NONNUTRITIVE SUCKING AND SUCROSE INDUCED ANALGESI A EFFECT ON HEART RATE, OXYGEN SATURATION, AND PAIN IN INTUBATED INFANTS By Harriet D. Miller M ay 2009 Chair: Charlene Krueger Major: Nursing Sciences Critically ill neonates who require artificial airways are unable to vocalize due to the blocking of their vocal chords by the endotracheal tube. Pain assessment in this neonatal population is difficult due to the inability of the infants to self report their pain with cries of distress. While pain is a common part of the hospital experience, nonnutritiv e sucking-induced analgesia with sucrose is offered less to intubated neonates. The purpose of this study was to determine the effect of nonnutritive sucking (NNS) combined with sucrose induced analgesia on heart rate, oxygen saturation, and pain behavior s as measured by the Neonatal Infant Pain Scale (NIPS) in intubated infants. Using a repeated measures cross -over design, 14 infants between the ages of 32 and 42 weeks were sampled by convenience from a Neonatal Intensive Care Unit. Each infant served as its own control, and were randomly assigned to participate first in one of two conditions resulting in 28 observations. In the treatment condition infants were offered NNS with sucrose, and in the control condition were not. Heart rate and oxygen satur ation were measured in 30 -second intervals during a 5 -minute baseline period, a heel stick, and 5 -minute follow up period. Pain behaviors were measured in one minute intervals. Findings were analyzed using a within -subjects repeated measures analysis of variance. Significant differences were noted between the control and intervention conditions. Heart rate significantly increased

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13 following the heel stick in the control condition; main effect F (df 1, 13) = 46.65, p < .001; phase effect F (df 3, 39) = 101.73, p < .001; interaction effect F (df 3, 39) = 24.69, p <.001. Oxygen saturation significantly decreased following the heel stick in the control condition; main effect F (df 1, 13) = 19.08, p = .001; phase effect F (df 3, 39) = p < .001; interaction eff ect F (df 3, 39) = p < .001. The NIPS Score significantly increased following the heel stick in the control condition; phase effect F (df 1, 13) = 697.88, p < .001. Findings will be used to further knowledge related to pain in intubated infants in the hospital setting

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14 CHAPTER 1 INTRODUCTION Despite what is known about the harmful effects of pain during the early developmental period, pain in intubated infants often goes unrecognized. This is because the cries of intubated infants are silenced by the same endotracheal tube that supports their lives by supplying oxygen. The lack of an audible distress cry mak es the assessment of pain difficult. Intubated infants are therefore seldom offered the pacifying effects of nonnutritive sucking ( NNS ) (Miller & Anderson, 1993). In order to effectively manage pain in intubated infants, health care professionals must learn to recognize the infants physiologic and behavioral response to pain. Along with establishment of t he existence of pain in neonates, attention to the treatment of pain has not followed. It is estimated that between 1995 and 2003 neonates cared for within neonatal intensive care unit s (NICU) end ured a total of 38,426 invasive and potentially painful procedures (DApolito, 2006). According to a s tudy published in the Journal of the American Medical Association, each infant during the first 14 days after admission to the NICU undergoes an average of 16 stressful or painful procedures per day (Carbajal, et al., 2008). Attempts to reduce pain and th e resulting negative outcomes without altering the stability of the infant with pharmacologic agents remain a challenge for the health care team Nonnutritive sucking with sucrose is a nonpharmacologic option that may provide a beneficial reduction in both immediate and long term physiological and behavioral responses to untreated sensations of pain Immediate Responses ( P hysiological and Behavioral) Immediate physiologic responses to pain in infants include sympathetic nervous system involvement ; notably increases in heart rate, respiratory rate, intracranial pressure, decreases in oxygen saturation, and changes in blood pressure (Stevens & Johnson, 1994). A dditional a utonomic nervous system involvement in infants yields alterations in skin color, nausea

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15 vomiting, and dilated pupils. Immediate b ehavioral responses to pain in infants include cr ies body movement, and changes in facial expression (Stevens, Johnson, & Horton, 1994). Despite differences in gestational age, facial expressions (particularly brow bulge, eye squeeze, and nasolabial furrow) are considered valid indicators of infant pain (Stevens, 1993). Physiologic indicators, including heart rate and oxygen saturation, are easily accessible in the intensive care unit, but are sometimes unrelia ble due to data obtainment error and not specific to pain alone (Barr, Rotman, Yaremko, Leduc, & Francoeur, 1992). It has therefore been concluded that when measuring procedural pain such as heel sticks, physiologic indicators should be used in conjunctio n with behavioral indicators, including behavioral state scores based on cries, body movements, and changes in facial expression (Stevens & Johnson, 1994). Long Term Responses to Pain (Physiological and Behavioral) Management of neonatal and infant pain i s important not only to provide comfort, but also to prevent longlasting negative consequences related to painful experiences (Grunau, 2002). It is believed that neonates may experience pain from the moment of birth, even when born prematurely. By 20 week s gestation neural pathways and sensory receptors are developed and intact. It is not until almost full gestation that the inhibitory pathways for pain modulation are mature (Anand, Phil, & Carr, 1989). The inability to modulate pain leads to a decreased pain threshold, and prolonged periods of hypersensitivity in premature infants (Fitzgerald, M., Millard, C., & MacIntosh, N., 1988). Even nonnoxious stimuli (such as a change in positioning or handling) may be perceived as painful (Evans, Vogelpohl, & Bo urguignan, 1997). Repetitive pain and local injury to tissue, such as repeated heel sticks, may further reduce the pain threshold (Anand, 1998; Reynolds & Fitzgerald, 1995). Pain has been found to have detrimental effects that compromise growth, developme nt, and health (Boss, 2002). Repeated pain may lead to negative physiologic outcomes further

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16 compromising the health of the infant. Some potential negative physiologic outcomes include increased peripheral vascular resistance, increased myocardial oxygen consumption, increased production of carbon dioxide, and decreased gastric immobility (Beacham, 2004). As a result, weight loss and fatigue may occur A major by -product of pain is stress. A cascade of biochemical reactions result from stress with i n pa rticular, the activation of the sympathetic nervous system which releases catabolic glucocorticoids (epinephrine, norepinephrine, and cortisol). The glucoc o rticoids retard protein synthesis, cell growth, and neuron myelinization. The result is a breakdow n of protein, carbohydrate, and fats stores delaying the repair of injured tissues (Piano & Huether, 1998). Increases in heart rate and blood pressure are evident with repeated episodes of untreated pain (Puchalski & Hummel, 2002). As a consequence, alter ations may occur in venous, intracranial, and arterial oxygen saturation (Stevens, Johnson, & Gibbs, 2000). A direct correlation was found between the number of episodes of hypotension and hypoxia and intraventricular hemorrhage in preterm infants (Low, e t al. 1992). B ehavioral responses to pain have included cries, alteration in body movement from relaxed to flexed or extended, and changes in facial expression from relaxed muscles to grimace (Stevens & Johnson, 1994). Application to Nursing The particip ation of nurses in pain management is crucial to achieve short and long term positive health outcomes for infants who are positioned to experience repetitive or severe pain. Attention to comfort is a foundational element of nursing (Watson, 1979). Ethicall y, there is an obligation for nurses to look for an expression of pain and to alleviate pain in those who cannot advocate for themselves (Beauchamp & Childress, 2008), This applies to an intubated newborn who cannot verbalize pain through a cry.

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17 Nurses are best positioned to assess, treat, and prevent pain in the hospital because they are nearest the patient. One frequently studied intervention nurses can employ to alleviate infant pain is nonnutritive sucking (NNS). Nonnutritive sucking is the placemen t of a pacifier into a neonates mouth to promote sucking behaviors without breast milk or formula, hence the term nonnutritive (Blass & Hoffmeyer, 1991; Gibbens, Stevens, Hodnett, et al. 2002). The mechanical effect from the act of orotacile suckling is hypothesized to work by blocking the bodys ability to transmit the sensation of a painful impulse back to the brain. This alteration of pain perception is commonly known as Gate Control Theory (Melzack & Wall, 1965). It has been hypothesized that if the pain is not recognized by the brain, or the transmission of the signal is blocked, the negative consequences of pain do not follow. More recent studies show that the combination of sucrose and NNS is more effective in altering the perception of pain than NNS alone (Harrison, Johnston, & Loughnan, 2003). In addition to Gate Control, the two additional mechanisms of pain modulation offered by the addition of sucrose are thought to be the release of short acting endogenous opio i ds and the attention gaining re sponse to the strong taste (Harrison et al., 2003). Sucrose is a disaccharide composed of fructose and glucose that combines for a strong, sweet taste (Blass & Hoffmeyer, 1991). The calming effects are from a mediated opioid response that is activated thr ough the taste receptors located at the tip of the t ongue (Blass & Watt, 1999). Taste -induced analgesia has been demonstrated in both human and nonhuman newborns and is dependent on the ability of the subject to detect a sweet taste --not merely through ing estion of the sucrose This is important for the study reported here because sucrose was administered orally to the tongue. Sucrose administered to preterm neonates by a nasogastric tube (not orally) failed to produce an analgesic effect for heel sticks (Ramenghi & Leve ne 1999) Thus, a simple intervention such as the

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18 combination of NNS with the oral administration of sucrose shows promise for promoting the mediation of pain in intubated infants Nurse researchers have a duty to find nursing interventio ns that will work and to validate their use at the bedside especially for patients who cannot advocate for themselves (American Academy of Pediatrics, 2000). This study was guided by the alteration of the perception of pain with the Gate Control Theory. T wo bioethical considerations, nonmaleficence and beneficence, and the concept of caring, were also used to guide this research. The altering of pain perception with NNS in combination with sucrose can potentially improve the health and development of seri ously ill infants by providing a nonpharmacologic treatment The purpose of this study is to determine the effect of nonnutritive sucking (NNS) combined with sucrose induced analgesia on heart rate, oxygen saturation, and pain behaviors (measured by the N eonatal Infant Pain Scale) in intubated infants between the ages of 32 weeks gestation to less than or equal to 42 weeks gestation. Specific Aims Specific Aim 1 Determine the effect of NNS and sucrose induced analgesia (treatment condition) on heart rate in intubated infants during a painful event (heel stick). Hypothesis 1 Infants will have lower mean heart rates in the NNS condition with sucrose (treatment condition) during a heel stick than those infants not offered NNS with sucrose (control condition ). Specific Aim 2 Determine the effect of NNS and sucrose induced analgesia (treatment condition) on oxygen saturation in intubated infants during a painful event (heel stick).

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19 Hypothesis 2 Infants will have higher mean oxygen saturations in the NNS condi tion with sucrose (treatment condition) as measured by noninvasive pulse oximetry during a heel stick than those infants not offered NNS with sucrose (control condition). Specific Aim 3 Determine the NIPS scores in the NNS condition with sucrose (treatment condition) in intubated infants during a painful event (heel stick). Hypothesis 3 Infants will have lower NIPS scores in the NNS condition with sucrose (treatment condition) during a heel stick than those infants not offered NNS with sucrose (control cond ition

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20 CHAPTER 2 REVIEW OF LITERATURE A steadily increasing number of premature infants are being kept alive through the extraordinary efforts of neonatal intensive care units (Aslam, Panjvani, & Rajegowda, 2007) Often, these neonates require respirato ry support in the form of artificial airways that is punctuated by daily painful procedures (including venous access and heel sticks). This study is guided by two bioethical principles, beneficence and nonmaleficence (Beauchamp & Childress, 2008), the conc ept of caring, and the Gate Control Theory. The author will use the Gate Control Theory to conceptualize the alteration of the perception of pain with NNS and sucrose -induced analgesia. Melzack and Wall (1965) theoriz ed a gating mechanism within the spin al cord and in the thalamus. These theoretical gates in the pain pathway can be opened or closed, allowing or not allowing pain to register in the brain. This results in the modulation of pain by closing the gate to the area of the brain that receives and reacts to the painful or noxious stimuli. For example, as in the study presented here, through the introduction of the intervention of NNS with sucrose analgesia Bioethical principles, such as beneficence and nonmaleficence, and concepts, such as caring, serve as guidelines for professional behavior. Healthcare agencies have attempted to address the issue of pain control through the creation of codes and position statements. What follows is a historical review of bioethical codes, pain, and bioethics an d infant pain Bioethical Codes The English physician Thomas Percival wrote the first code of bio ethics in 1794 entitled Medical Ethics; or a Code of Institutes and Precepts to serve as a guide for physicians. The code asserted moral authority and independence of physicians to serve others. It was later revised and adopted by the American Medical Association (AMA) in 1847 to address health care

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21 needs (Center for the Study of Ethics in the Professions [CSEP], 1999). The AMA Code of Medical Ethics include d, when pestilence prevails, it is their (physician) duty to face danger, and to continue their labours for the alleviation of the suffering, even at the jeopardy of their own lives. This provision was deleted in 1977 (http://www.library.dal.ca/kellogg/Bioethics/codes/codes.htm ). Codes of bio ethics are now the defining standard of professionalism for health care providers. They were put in place to shift decision -making amongs t physicians from autonomous practice to a more standardized process of bio ethical behavior The most unique contribution of Percivalian ethics was the transition from individual physician duties to core collective responsibilities of the profession. Spec ifically, the role of the physician to serve others, and care for the sick was introduced. A moral consideration was also noted with the emphasis on individual honor for the physician (DePender & Ileda Chandlere, 1990) Later, specific guidelines for ethi cal behavior were developed. In 2003 Beauchamp suggested the use of specification (a method which reduces the vagueness of principles) to specify the ethical guidelines. Four principles were identified by Beauchamp as foundational to biomedical ethics: 1 ) respect for autonomy, 2) nonmaleficence, 3) beneficence, and 4) justice (Beauchamp, 2003; Macklin, 2003). Four Principles of Bioethics The first foundational principle of biomedical ethics is respect for autonomy. This principle encompasses freedom from controlling forces or self rule. Two conditions essential for autonomy are liberty (the absence of controlling forces) and agency (the ability to act intentionally) (Beauchamp & Childress, 2008). The principle of respect for autonomy was not chosen as a guideline for this research because infants do not exhibit liberty, in addition to agency

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22 The second foundational principle of biomedical ethics is nonmaleficience. The principle of nonmaleficence involves the act of not inflicting or causing harm. It involves refraining purposely from actions that cause harm. The maxim Primum non nocere associated with medical ethics means first do no harm (Beauchamp & Childress, 2008). The principle of nonmaleficience was chosen because it closely related to this s tudy of doing no harm in the infant population The third foundational principle of biomedical ethics is beneficence. The principle of beneficence involves obligation and moral duty. Examples include preventing harm, protecting and defending, and removin g conditions that cause harm (Beauchamp & Childress, 2008). Beneficence would require nurses to identify and alleviate pain and suffering in patients. The principle of beneficence was chosen to guide this study because it was consistent with the concept of preventing both short and long term damage caused by untreated pain The fourth foundational principle of biomedical ethics is justice. Fair and equitable are terms that have been associated with the definition of justice. It was noted, however, that t he principle of justice was not independent from other principles, notably beneficence and nonmaleficence (Beauchamp & Childress, 2008). It was for this reason that the principle of justice was not specifically chosen to guide this research Caring In her major work entitled Caring, a Feminine Approach to Ethics & Moral Education (1984), Nel Noddings, the distinguished professor from Stanford University, explores a feminine approach to ethics. Her argument is that caring is basic in human life. She makes the distinction between being cared -for and caring about. Caring-for comes first in life to be followed by extension to caring about, or to care about others. Noddings argues that caring about others is

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23 fundamental to a sense of justice. Natural caring comes before ethical caring and is similar to that of a mother for a child. Caring is an extension of the positive duty of beneficence. A positive duty is the ethical obligation to act. A negative duty is the ethical obligation to withhold an action tha t would be harmful. This is consistent with nonmaleficence (Beauchamp & Childress, 2008). K ellogg (2006) states the Hippocratic Oath is foundational to western medicine and includes the concepts of beneficence and nonmaleficence. T he Nuremberg Code addr esses these concepts by requiring the avoidance of and protection from injury (Kellogg, 2006). Later, the Declaration of Helsinki in 1964 require s the protection of the well being of human subjects (Kellogg, 2006) Despite this history of ethical obligations to do good and avoid harm, m odern medical practices expose infants to pain that is repetitive, acute, and prolonged (Anand & Phil, 2001). One recommendation made is that clinical units should develop written guidelines for pain management in neonates. Th ese guidelines are often expressed through the adoption of existing codes of ethics that address pain, either directly or indirectly. Conflicts regarding the need to perform necessary procedures that cause harmful pain and the medical benefits continue. Pr inciples of medical ethics, such as nonmaleficence and beneficence, are relevant to the issues of infant pain. Given that infants are persons and entitled to moral regard, an understanding of the moral principles that guide medical care is important in thi s vulnerable population. Ethical principles can serve as guides in the treatment of pain Medical and Nursing Principles Related to Pain Healthcare agencies and organizations have attempted to address the issue of pain control through the creation of stand ards, codes, and position statements. The following describes the many diverse efforts including the standard of pain management by the Joint Commission on Accreditation of Healthcare Organizations. Codes of ethics, such as those supported by the

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24 American Nurses Association and the National Association of Neonatal Nurses are described. Position statements on infant pain, such as those created by the American Academy of Pediatrics, the American Pain Society, the National Association of Neonatal Nurses, and the American Nurses Association are included The primary organization that accredits hospitals in the United States, the Joint Commission on Accreditation of Healthcare Organizations [JCAHO] (2001), released standard RI.1.2 that stat es patients must be involved in all aspects of their own care, including the effective management of pain (JCAHO, 2001). This means nurses must take cues from their patients to adequately interpret their indications of pain. In addition, the American Hospital Association (AH A) released the Patients Bill of Rights in 1973 outlining the rights of a patient. Later in 1992 revisions were made to include the right of the patient to receive considerate and respectful care (AHA, 1992 ). Application to P ediatrics More specifically t he American Academy of Pediatrics and the American Pain Society (2001) found the issue of procedure related pain in infants important, and comprised a joint statement that advocates for the alleviat ion pain when possible. For procedural pain, the statemen t says that anticipation of the patients pain is the key to optimal management, and that adequate treatment is the humane approach As a consequence, the measurement of pain i s now considered the fifth vital sign and is common pr actice in hospitals and cl inics. Unfortunately, in practice there is inconsistency on how to assess and measure pain in nonverbal populations T aken together, this suggests that bedside nurses are practicing the assessment of pain without research evidence t hat show s consistency a nd efficacy of their techniques. In response to the need for further guidance regarding the management of infant pain, t he National Association of Neonatal Nurses (NANN) r eleased the Position Statement Number 3019

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25 on Pain Management in Infants in 1999. I t states nurses must be diligent in the management of infant pain (Duhn & Medves, 2004). The NANN believes that infants do feel pain, and pain assessment should include both a physiologic and behavioral dimension. In the study reported here, pain was meas ured by observing a combination of behavior s utilizing the Neonatal Behavioral Pain Scale (NIPS), and physiological factors. The NIPS scores procedural pain behavior in both term and preterm infants (Duhn & Medves, 2004). The National Association of Neonat al Nurses also released a code of ethics that mandated that the primary responsibility of the nurse is to the patient, including the protection of the patients physical well being (NANN, 2006). The assessment, prevention, and alleviation of pain in an evidence-based manner fall within this ethical code. One of the goals of neonatal caregivers a ccording to the 2006 American Academy of Pediatrics Policy Statement is to prevent neonatal pain. It, however, further states major gaps remain in the knowledge of the best way to prevent and relieve pain. In the latest position statement for pain management of infants by the National Association of Neonatal Nurses (NANN), emphasis is placed on providing the most effective pain relief that can be given safely (National Association of Neonatal Nurses, 1999). Currently the National Association of Neonatal Nurses set the standards for the neonatal nursing profession. The organization further states it has a moral and ethical responsibility to include new knowledge and methods of infant pain assessment and treatment. In general, the profession of Nursing is governed by the International Council of Nurses (ICN) and the American Nurses Association (ANA). Both governing bodies have developed codes of ethics to guide nur sing practice. The ICN (2006) released their code of ethics, the preamble of which states that nursing care is respectful and unrestricted by considerations of

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26 age. T he professional association that represents all nurses, the ANA, also has a code of ethics that gives nurses the duty to both prevent illness, such as those caused by untreated procedural pain, and to alleviate suffering. The preface to the ANA code supports the principles of autonomy, beneficence, nonmaleficence, and justice (ANA, 2006) Through the creation of these codes and position statements, these governing bodies of nursing have attempted to guide and support ethical decision making in nursing practice. In summary, diverse healthcare agencies have attempted to address the issue o f pain control through the creation of some of the above mentioned codes and position statements. P ainful procedures continue to exist in the hospital setting Pain assessment is essential for practice, but the measurement of pain in the nonverbal popula tion remains difficult and at best, an estimate. The nonverbal intubated infant is not able to verbally state the presence of pain, and physiologic indicators such as vital signs are often unreliable. Physiologic indicators may not be specific topics sinc e they reflect a nonspecific response to stress (Barr, 1992). A more scientifically grounded, evidence -based approach to the assessment and treatment of neonatal pain is therefore necessary. The goal of this study was therefore to use an evidencebased a pproach to address the issue of infant pain control A functional theory, the Gate Control Theory, was identified and used to assist in the understanding of the alteration of the perception of pain through NNS in intubated infants Pain Gate Control Theor y The Gate Control Theory is the theoretical framework identified for use in this study to illustrate the alteration of the perception of pain with NNS and sucrose induced analgesia, and to further depict the effect on heart rate, oxygen saturation, and pa in assessment. The Gate Control

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27 Theory is a functional theory, which can be used to describe the phenomenon of NNS and its influence on pain The behavioral pain response to noxious stimuli is detected in infants as early as 24 weeks gestation (Coskun & An and, 2000). Pain signals traveling to the brain can be interrupted by stimulating the periphery of the pain site, the appropriate signal -carrying nerves at the spinal cord, the corresponding areas in the brain stem, or the cerebral cortex. The ability of the nerve to detect the pain signal, or noxious stimuli, and transport that information to the cerebral cortex is known as nociception (McGrath, 1993). Activities that inhibit nociceptive transmission, and thereby close the pain gate include rubbing, ma ssage, and cuddling (Hatfield, 2008). The p ain gate to the brain can be closed by stimulating nerves responsible for carrying the touch signal, or mechanoreceptors, which enables the relief of pain. P ainful stimuli may travel down the nerve pathways, but the sensation of pain would not be recognized because the theoretical gate would be closed (Melzack & Wall, 1965). Studied t echniques illustrating this include massage, rubbing, and the application of heat and cold (Doody, Smith, & Webb, 1991). In a recen t study by Jain, Kumar, & McMillan (2006) t he rhythmic and continuous sucking action of NNS which is similar to massage or rubbing was found to act as a stimulus and alter the transmission of pain. Nonnutritive sucking provides a soothing relief before, during, and after a painful procedure by clos ing the p ain gate and altering the pain transmission Nerve fibers which transport the transmission of pain come in two different sizes. The information that needs to travel to the brain fastest will use the larg e diameter myelinated fibers called A -fibers. Motor information regarding movement and proprioception, the sense of where body parts are located in space, utilize the large, faster fibers to travel from the periphery to the brain. Information that does not need to travel as fast uses smaller, slower, nonmyelinated fibers

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28 called C -fibers. These fibers carry information regarding pain, temperature, and physical distortion such as bending and stretching (McGrath, 1990, Helms & Barone, 2008). The physiologic m echanisms involved in the ability to detect noxious stimuli, and then transmit the painful stimuli to the brain take the slower route of the C -fibers. This is believed to be a primitive survival mechanism because although pain reception is important for h ealth, it can be inhibiting in a dangerous or threatening situation, and thereby not the first priority for survival (Melzack et al., 1965). In some instances, flight is more important than pain relief. In order to do this one must be able to move quickly and freely. One must know where ones body parts are located in order to move successfully out of harms way. In this instance, pain is not the priority. Drawing on this knowledge, the Gate Control Theory was built. Since it is theorized that the sti mulat i on of the periphery of the pain sit e, or the appropriate signal -carrying nerves at the spinal cord, diminish the experience of pain, studies have been conducted to test this theory. In a recent study by Jain, Kumar, & McMillan (2006), prior leg massage wa s noted to decrease pain responses to heel sticks in preterm infants. Harrison et al. (2003) stated that the rhythmic and continuous sucking action of NNS can alter the transmission of pain by providing soothing relief before, during, and after a painful procedure via the mechanism of closure of the pain gate Level of Theory The Gate Control T heory is an example of a middle -range theory. As described by Meleis (1997), middle range theories consider a limited number of variables, have a particular substa ntive focus, and are more susceptible to empirical testing. A middle range theory is appropriate to guide nursing research specifically because it is measurable. The Gate Control Theory contains four key concepts. The first key concept is the painful sti mulus, or a negative stressor such as the presence of noxious or painful stimuli. The second is

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29 the interruption of the stimulus. The intervention to alter the perception of the stimulus is the closing of the pain gate. The third key concept is the tr ansmission of the painful stimulus whereby no intervention to alter the perception of the stimulus occurred, or no closing of the pain gate. The last key concept is the pain response. This is the stage following the transmission of painful stimulus. A pplication of the key concepts of the Gate Control Theory is described below (see Concept Map Figure 2 1) Painful stimulus: The negative stressor such as the presence of noxious or painful stimuli. In th e study reported here a heel stick for a blood samp le w as employed to induce a negative stressor. Intervention: Nonnutritive sucking with sucrose induced analgesia was the intervention used to alter the perception of the painful stimulus. This intervention was begun 2 minutes before the heel stick because the peak efficacy of the opioid effects is 2 minutes after administration (Harrison et al., 2003). No intervention: Absence of NNS (ONNS) with sucrose; the control condition. Pain response: Stage following the transmission of painful stimulus in the absence of NNS with sucrose induced analgesia. Positive outcome: Improved respiratory function measured by increase in mean oxygen saturation levels, decrease in mean heart rate, and restful state as defined by decrease in NIPS score (Lawrence et al., 1993) following painful stimuli. Negative outcome: Increase in mean heart rate, decrease in mean oxygen saturation, or presence of pain state as defined by increased NIPS score (Lawrence et al., 1993). Relational Statements of the Gate Control Theory Concepts are ideas or constructs that are labeled by means of language (Walker & Avant, 1995). Concepts allow the classifying of experiences in a meaningful and often measurable way. They serve as fundamental elements essential for theory building. Before a theory can be predicted or explained, it must be formulated. When relationships are observed between one or more concepts, it is expressed as a statement. A relational statement identifies a relationship between one or more concepts (Peterson & Bredow, 2004).

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30 Relational statements of the concepts of the Gate Control Theory include the following: a painful stimulus initiates the transmission of the stimulus. Transmission of the painful stimulus results in a pain response. Interruption of the stimulus decreas es the transmission of the painful stimulus and decreases the pain response. A painful stimulus without intervention will lead to a pain response and negative outcome. This is a bidirectional relationship. A pain response would lead to a negative outcome, which could lead to heightened negative responses and outcomes in a cyclic pattern (Anand, 1998). A painful stimulus with intervention will result in a positive outcome. This is a unidirectional relationship. Application of the relational statements to t his study include the experience of a heel stick (painful stimulus) which can be altered to avoid a painful perception (closure of the pain gate) with the intervention of NNS with sucrose (treatment group). No intervention of NNS with sucrose (control g roup) following a painful stimulus results in transmission of the painful stimulus (no closure of the pain gate), a pain response, and adverse outcomes (increased heart rate, decreased oxygen saturation, and lower NIPS scores). In order to better unders tand pain behavior and relationships, clear definitions of the concepts and statements were presented Theoretical Assumptions of the Gate Control Theory Recognizing assumptions of a theoretical work is the first step in understanding the theory (Barnum, 1 998). Theoretical assumptions are beliefs assumed to be true. Evidence exists of the validity or invalidity of the assumptions as a result of empirical testing (Walker & Avant, 1995). A theoretical assumption of the Gate Control Theory is the interrupti on of the transmission of the painful stimulus (closure of the pain gate) is assumed to be not noxious, and therefore will result in no pain response (Melzack & Wall, 1965; Dickenson, 2002; Stojanovic & Abdi, 2002; Fletcher, 2004; Hatfield, 2008). Appli cation of the theoretical assumption to this study is that the introduction of NNS with sucrose will not be a noxious stimul us The studies reviewed here did

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31 not reveal any instances of increased heart rates, decreased oxygen saturation, or increased NIPS scores in the presence of NNS with sucrose. T he Gate Control Theory serves as the basis for the explanation of the alteration of pain perception through NNS. Like pain itself, the Gate Control Theory is not age specific and can be modified for the populat ion it is applied to In a recent study by Hatfield (2008), the Gate Control Theory with oral sucrose analgesia provided the theoretical framework to examine infant pain. Forty infants ages 37 to 42 weeks gestation received oral sucrose with nonnutritive sucking prior to routine immunizations at their 2 and 4 months well -child visits. It was concluded that sucrose was effective for decreasing behavioral pain response after immunization. However, the infants in the study were all classified as healthy a nd not hospitalized Pain in Infants While infant pain is discussed in contemporary nursing and medical literature, few studies address the specific concerns of infants who cannot vocalize their discomfort because of intubation. Infant pain itself is a rec ent concept in the literature. Swafford and Allen (1986) reported that pediatric patients seldom needed medication for the relief of pain because they tolerate discomfort well. Up until the mid 1980s, many infants did not receive anesthesia for surgery, and postoperative analgesia was the exception, rather than the norm (Franck, 2002). It has been established that infants, full term or preterm, can detect and respond to painful stimuli (Franck, 2002). Dunn and Medves (2004) stated that the anatomical struc tures necessary to process pain are mature from mid to late fetal gestation. This is compounded by the decreased inhibitory ability found in infants who were repeatedly exposed previously thereby causing increased sensitivity to pain a condition that actua lly increases the vulnerability to pain of an already vulnerable population.

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32 Though attempts to manage infant pain have improved, the inequities between adult and pediatric patients have continued and are well documented in the literature. Compared to adul ts, children continue to be poorly managed. Eland and Anderson (1977) compared 25 children, aged 4 to 18, with 18 adults postoperatively. The children received 24 doses of analgesic while the adults received 671. Beyer, DeGood, Ashley, and Russell (1983) c ompared children and adults who received open heart surgery. In a single postoperative period t wenty -five percent of the children received no analgesia postoperatively. In contrast, a ll of the adults received analgesics postoperatively. This disparity in t reatment between those who are able to verbalize pain (those not intubated or with verbal cognition) and those who are not continues today (Gibbins et al., 2002). This is consistent with the in ability of the intubated infant to advocate for itself due to a ge and intubation. These studies demonstrate respect for the principles of nonmaleficence and beneficence with adults who receive analgesia because of their ability to seek pain relief, but not with infants and children who are not able to seek relief. T he lack of attention to infant pain may be due to the lack of understanding by the healthcare provider of the ability of infants to perceive and respond to pain (Franck & Lefrak, 2002). Common myths regarding pediatric pain management include the following : infants do not feel pain because their nervous system is immature, children do not feel pain as intensely as adults, children do not remember pain, children who do not act like they are in pain are not in pain, children can say where it hurts, it is unsa fe to administer narcotics to children because they may become addicted, and the child needs to experience pain (Burokas, 1985). This is in addition to the fear of possible side effects of anesthetics and analgesics in infants, including respiratory depres sion (Franck & Lefrek, 2002). Franck also found the fear of possible side effects of anesthetics and analgesics in infants may discourage the aggressive use of pain relieving

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33 medications in infants. Anand and colleagues (2005) stated that awake intubation occurs more often in young children, and that the procedure is associated with severe pain and stress, changes in vital signs, and increased difficulty of the procedure itself from failure to anesthetize. According to the American Academy of Pediatrics ( AAP) the need to relieve pain is significant due to the harmful effects of pain on the infants developmental outcome (A AP 2002). The pain response results in increased heart and respiratory rates, increased blood pressure, decreased oxygenation saturati on, and a release of adrenal stress hormones. With chronic pain, precious e nergy resources required for growth, development, and healing are used instead to cope with pain. Disturbances of sleep cycles, feeding patterns, and self regulation have also been associated with pain. As a result, growth patterns in regard to height and weight gain are interrupted (Mitchell & Boss, 2002). The disturbed sleep cycle resulting from pain has been described as having immediate and long -term consequences. The neurologic al systems that control attention, emotion, and the sleep/wake states interact with one another. Pain and stress resulting in repeated disruptions can affect the infants neurodevelopment, putting the child at risk for later emotional disturbances, learnin g disorders, poor adaptive behavior, and attention deficits (Grunau, 2000). Attempts to pacify infants may lead to reduced disturbances of these cycles (Miller & Anderson, 1993). One such mechanism of pacif ication is nonnutritive sucking Interventions to Treat Infant Pain Sucking behavior has its origins in the early development of the infant. Ingelman-Sundberg and Wirson (1965) documented sucking behavior prior to birth as early as 18 weeks gestation. Infants possess the ability to consistently suck by 32 weeks (Medoff Cooper, Verklan, & Carlson, 1993). Nonnutritive sucking (NNS) is believed to be a pacifying mechanism with reports dating back to the 15th century (Cornelius, DAuria, & Wise, 2008). The pacifying effects

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34 of nonnutritive sucking were first noted in relationship and to newborn movement (Kessen & Leutzendorff, 1963; Kessen, Leutzendorff, & Stoutsenberger, 1967). Only recently has the relationship between painful distress and the effect of nonnutritive sucking been under scientific study In 1984 Field & Goldson studied behavioral state, heart rate, and respirations during heel stick procedures. Samples compared healthy, term infants (N = 48), preterm infants (N = 48), and subjects in intensive care nurseries (N = 48). Unequal and varying d egrees of acquity were compared along with a limited sample size. Lack of clarity as to whether the subjects in the intensive care nursery were intubated, and the lack of sucrose were also identified. Because of the lack of sample and procedure descript ion, the need for further investigation continues In 1989 Campos compared the effectiveness of swaddling and pacifiers in reducing pain induced distress in 2 week old infants who received heel sticks and 2 month old infants who received injections. In th e 2 week old group who received pacifiers, the heart rate levels and crying declined more rapidly than when in the swaddling condition. In addition to differing ages and varying interventions, the sample sizes were small (N= 32). In 1994 DiPietro and ass ociates examined t he behavioral and physiologic effects of nonnutritive sucking during gavage feeding in preterm infants. It was noted that the decrease in heart rate and elevation of pain threshold were not sustained following discontinuation of the inte rvention (nonnutritive sucking). This suggests the intervention of NNS was causative of the favorable physiologic outcomes of decreased heart rate and increased pain threshold. The continuous and rhythmic sucking action of nonnutritive sucking has pote ntial correlation to improved respiratory and gastrointestinal function, and reduced energy expenditure and behavioral stress. Intubated infants are not usually offered NNS with sucrose due to the lack

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35 of an audible cry, thus the absence of the perception of distress Nonnutritive sucking with sucrose has been documented to have multiple benefits for infants. Improved respiratory function can be related directly to increased transcutaneous oxygen tension (TcPaO2). A meta analysis of the effects of NNS on Tc PaO2 was conducted through a computer search on research over the past 30 years. The TcPaO2 levels were noted to be significantly increased with NNS (Shiao, Chang, Lannon, & Yarandi, 1997). Another potential benefit of NNS may be improved gastrointestinal function. It has been shown that sucking initiates and assists in the completion of the gastrointestinal cycle. Gastric secretory and motor functions needed for digestion are increased during NNS (Widstom et al. 1988). Improved weight gain may result f rom improved gastrointestinal function, as well as decreased energy expenditure. Nonnutritive sucking has also been correlated with cardiac functioning in infants. Energy expenditure and heart rate have been directly correlated. Woodson and Hamilton (1986) found that NNS decreased heart rate leading to the conclusion that NNS decreased energy expenditure. Although sample size was limited (N = 10), Miller and Anderson (1993) concluded that heart rates were lower for those intubated infants in the NNS conditi on than those receiving routine care during and following intravenous catheter insertion The analgesic effects of sucrose have been reported in both term and preterm infants (Herschel, Khoshnood, Ellman, Maydew & Mittendork, 1998). Blass and Hoffmeyer (1991) were the first to examine the combined effects of NNS with sucrose for relie f of procedural pain in the neonatal population. The combination of sucrose and NNS was found to have a more synergistic effect than the use of sucrose or NNS alone (Cabajal, Chuvet, Couderc & Olivier Martin, 1999). The analgesic effect of sucrose is reversed with the administration of naloxone

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36 (Barr et al., 1995), an opioid antagonist, suggesting that the action of sucrose is similar to that of opioid analgesics. The analgesic action of sucrose may involve pain -modulating mechanisms that interfere with pain transmission (Barr et al., 1995). Following a review of randomized controlled clinical trials, the International Evidenced Based Group for Neonatal Pain published guideline s for the management of pain in infants. The recommended sucrose solution to be used with a pacifier as a pain relief measure for term infants was 24% sucrose with a maximum dose of 2 ml, and 12% to 24% sucrose with a maximum dose of 1 ml for preterm infan ts (Anand & Phil, 2001). Though pain and a lack of oral stimulation in the intubated infant have been found to have detrimental effects such as compromised growth, development, and health (Boss, 2002) no study was identified in this review that used NNS with sucrose in intubated infants One explanation is that they are not offered the pacifying effects of NNS due to the presence of the endotracheal tube which occupies the oral cavity and silences the cry Research does not support withholding the interv ention that is effective in other infant populations. According to the ethical principles of nonmaleficience, beneficence, and caring, nurses are ethically bound to assess and treat pain T he offer of a safe and effective method of pain reduction, such a s NNS with sucrose, would fall in the purview of the nurse Bioethics and Infant Pain Considerations in Nursing Though physicians write (or withhold) the orders that allow the management of pain in the hospital setting, the primary responsibility for pain management in the hospital is assigned to nurses (Simons, Franck, & Roberson, 2001). One obvious moral conflict is that to provide medical benefit to patients, it is often necessary to perform treatments that cause harmful pain. One way to evaluate and bal ance this dilemma is through the guidance of bioethical principles. While physicians may evaluate what treatments are best and necessary to restore health, it

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37 requires a level of paternalism and a compromise of self determination or autonomy. It has tradi tionally been the role of nurses to advocate on behalf of patients to physicians. This is one way of minimizing potential harm and to promote the ability of the infant and parents to keep their voices Factors Impacting Nursing Assessment o f Pain The activ e and essential role nurses play in pain management is recognized in the literature. Because nurses are the caregivers at the bedside, they make judgments regarding the assessment of pain and implement pain relieving interventions. Nurses perception of pa in is the primary precursor to symptom relief. In an attempt to explore factors that influence nurses assessments of their patients pain, Hamers, Abu Saad, Halfens, and Schumacher (1994) directed a qualitative study exploring pain assessment and interven tions. Data was collected using a semi structured interview, observation of subjects, and examination of nursing records. The subjects were a convenience sample of 10 nurses working in a pediatric ward in both a general and university hospital in the Nethe rlands. Factors identified that influenced nurses decisions were the following; medical diagnosis, childs facial expressions, age, parents, and the nurses knowledge, experience, attitude, and workload, infant behavior, and physiology. Despite the limit ed number of participants and cultural differences, the findings were repeatedly observed in other studies. What follows is a review of studies identifying similar findings in relation to the nursing assessment of pain in infants Medical Diagnosis The in fants medical diagnosis was identified as a component that influenced nurses pain assessment. The more severe the medical diagnosis, the greater amount of pain anticipated by the nurses. This observation also held for the implementation of pain relieving interventions (Hamers et al., 1994, Hamers et al., 1996).

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38 Infants Behavior, Expression, and Physiology In a 1989 qualitative study examining nurses perceptions of pain in the neonatal intensive care unit, infant behavior was categorized according to sev en areas: facial expressions, facial color, limb movement, torso activity, breathing pattern, and cry state (Pigeon, McGrath, Lawrence, & MacMurray, 1989). Children in pain were more likely to be crying, to have marked changes in facial color, to have rigi d limbs and torso, to have irregular breathing, and to have movement. However, there was no discernible relationship between specific procedures and severity of pain. For example, handling and changing a diaper were identified by some RNs as a cause of mil d pain and by others as a source of severe pain. In an attempt to describe behaviors of infants and toddlers when in acute pain, 32 children were observed following surgery, fractures, or burns (Mills, 1989). In this qualitative study using grounded theory methodology, data sources included child observations, parent interviews, and patient records. Three pain behavior categories were identified including motor movement, communication, and facial expressions (Mills 1989). The children were observed on three separate occasions. Parent interviews were audio taped following the observations. Parents were able to describe behaviors that indicated pain in their child. Pain was communicated by infants (birth to 3 months of age) through crying. Some nurses state d that sustained crying was their cue to give analgesics to infants. Crying in infants from birth to 3 months of age was intermittent and less sustained than in older infants. The significance of Mills findings is that some nurses stated that sustained cry ing was their cue to give analgesics Infant A ge Certain characteristics of the child were noted to influence the nurses pain assessment and intervention including the characteristics of the childs facial expressions and chronological age (Hamers et al., 1994). This was further supported in a study examining postoperative assessment

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39 of pediatric pain, crying was identified as the major indicator of pain (Hultgren, 1990). In this qualitative study, 48 RNs from a convenient sample of pediatric and neonatal intensive care units were interviewed utilizing open -ended questions. Over 60% of the nurses in this study described the behaviors of crying and agitation as warranting pain medication administration. Parental P articipation Parental participation and support was a factor in the nurses perception of pain. A qualitative study was reviewed involving in -depth interviews of 24 parents of children hospitalized on a surgical ward and 11 members of the nursing staff. A parent suggested that health professionals co uld only respond to physical signs and could not recognize her assessment of subtle changes in her child (Calley, 1997). In a study that combined qualitative and quantitative methods, 20 parent and 20 nurse interviews were conducted. The qualitati ve method of phenomenology was used to guide the interviews. Findings revealed that the nurses perceived that the parents were receiving more support than the parents reported. The parents reported being more satisfied with their childrens pain management and the children received more analgesics when they were cared for by a nurse with a lower educational grade (Simons, 2002). Nurse K now ledge, Work Experience, and A ttitude In Hultgrens 1990 study, the researcher cited prior work experience as the m ajor influence on analgesic administration by nurses. Pain relief was the most common goal in administering narcotics in the immediate postoperative period. However, nurses with an associate A rts degree or hospital diploma education were much more likely t o state that the goal of narcotic administration was keeping the patient quiet and calm. Nursing decisions to medicate and medication choices also differed. Nurses differed widely in how much pain the infant should

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40 have by the second day. Seven out of 36 respondents felt acetaminophen should be sufficient by the second postoperative day In 2005 Van Hulle collected data from nurses (N = 67) regarding nurses knowledge and attitudes of childrens pain. It was reported that most demonstrated knowledge and a positive attitude toward relieving pain, but lacked knowledge of the occurrence of respiratory depression and thought the children over reported their pain. Common myths of pediatric pain exist. One common myth is the idea that children do not rem ember pain. It is of note that in this study after the first burn dressing change, an 8 -month -old infant cried in anticipation of events. She cried when she saw masks on nurses and when she was physically moved to the treatment room. That behavior was perhaps indicative of remembering a painful event. Motor behaviors have been misinterpreted regarding pain. Efforts to self -console have been misrepresented as evidence of the absence of pain. Attempts by the child to self distract by playing briefly with a to y may not indicate that the child is pain free and not in need of analgesics (Mills, 1989). The misinterpretations of pain may be due to the nurses knowledge, work experience, or attitude regarding pain. Another qualitative study utilizing grounded theor y methodology was reviewed which described how parents and nurses respond to hospitalized young children experiencing pain from surgical interventions. Participant observation was used to identify care behaviors. Interviews with 22 parents, 24 nurses, and 11 children were also conducted. The children stated that their parents presence was the major care practice useful in relieving the pain. Comforting the children was not noted as a major activity for the nursing staff. Nonpharmacologic nursing measures, such as teaching the child relaxation techniques, were rarely used by the nurses. Providing analgesic medication was the most frequent practice conducted by the nursing staff.

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41 However, the degree of pain relief was not always adequate for the children (Woodgate & Kristjanson, 1996). In review of the literature dealing with nurses perceptions and attitudes of pain, the concept of comfort was also examined. Comfort has been contrasted with discomfort and viewed as a state of well being. Pain has been assoc iated with discomfort. Using a phenomenological method, 36 patients who had experienced traumatic injuries or life threatening illnesses were invited to tell their stories with minimal interruption from the researcher. The theme emerged that comfort was no t an ultimate state of peace and serenity but rather the relief from discomfort (Morse, Bottorff, & Hutchinson, 1995). In a similar study conducted in 1994 by Morse, Butoroff, and Hutchinson, the phenomenology of comfort was again explored. The authors arg ued that the goal of providing total comfort was unattainable in patient care. The role of nursing is to enhance comfort, and to ease and relieve distress. In an observational study involving nurses on 36 shifts, Twycross (2007) noted that pain administ ration practices did not conform to current recommendations. Pain assessment was not routinely performed, or non -drug methods for pain relief consistently used. Further investigation for practice reasons (lack of knowledge, attitude, or workload) was nee ded. Nurses Workload In 2007 observational studies were reviewed to explore the relationship between nurse staffing and patient outcomes (Kane, 2007). Better patient outcomes in intensive care units and in surgical units were associated with higher n urse/patient ratios. Positive outcomes were associated with decreased mortality, pressure ulcer incidence, invasive line sepsis, and respiratory infection. However, the amount of nursing knowledge, or experience was not addressed. Also, pediatric units w ere not included.

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42 Infant pain management involves not only the infant, but also the health professional and family. Factors impacting the nursing assessment of infant pain were discussed including the infant (diagnosis, behavior, expression, physiology a ge), parent (parental participation), and nurse (knowledge, experience, attitude, workload) Toward an Effective A ssessment of P ain in I nfants In order to achieve effective pain management, an effective pain assessment tool is needed. Because infants can not self report, physiological indicators (heart rate, respiratory rate, oxygen saturation, blood pressure, palmar sweating, vagal tone, plasma cortisol, catecholamine levels) have been measured to assess pain (American Academy of Pediatric Policy Statemen t, 2006). Physiological indicators, however, are sometimes unreliable due to data obtainment error and are not specific to pain alone (Barr, Rootman, Yaremko, Leduc, & Francoeur, 1992). Behavioral indicators (facial expressions, crying, movement) have al so been used to assess pain, but may be absent or diminished if the infant is pharmacologically or neurologically impaired. Physiological and behavioral indicators are also further defined by chronologic age. For example, some pain assessment tools are a ge specific for preterm or term infants. Therefore, a multidimensional pain assessment tool appropriate for chronologic age measuring both physiologic and behavioral components is recommended (American Academy of Pediatric Policy Statement, 2006). Multipl e pain assessment tools have been developed to assess infant pain. Example of multidimensional pain assessment tools include the PIPP (Premature Infant Pain Profile), CRIES (Crying, Requires Oxygen Saturation, Increased Vital Signs, Expression, Sleepless ness), NIPS (Neonatal Infant Pain Scale), N -Pass (Neonatal Pain Agitation and Sedation Scale), PAT (Pain Assessment Tool), and the SUN (Scale for Use in Newborns) (American Academy of Pediatrics, 2009). The pain assessment tools measure different physiologic and behavioral indicators, such as blood pressure and sleep patterns for the PAT. The nature of pain assessed also differs. The

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43 CRIES pain assessment tool is designed specifically for postoperative pain (American Academy of Pediatrics, 2009). The multidimensional pain assessment tool chosen for this study was the NIPS (Neonatal Infant Pain Scale) which measures respiratory patterns as a physiologic indicator, and facial expression, cry, movement of arms and legs, and state of arousal as behavioral in dicators. Procedural pain, such as heel sticks, is the type of pain recommended to be assessed with the NIPS (Duhn, & Medves, 2004). The NIPS was chosen as the pain assessment tool for this study due to the multidimensional ability (physiologic and behavioral), age considerations (infant), type of pain recommendation (procedural), and ease of use. With all that is now known about the detrimental effects of both acute and long term untreated pain on the future health and development of infants, it is the right of infants and their parents to expect and to receive adequate pain management. It is important to note that infant pain is articulated in the literature only through the experiences of caregivers whether nurses, physicians, or parents. As a c oncept, it is impossible to operationalize infant pain through the spoken experiences of infants because of the nonverbal nature of infants. Franck, Allen, Cox, and Winter (2005) found that parents attributed most infant pain to medical procedures, though Simons, Franck, and Roberson (2001) stated that parents had low expectations for the relief of their childs pain. Homer and colleagues (1999) found that the primary reason expressed for dissatisfaction on a hospital post -discharge survey was inadequate ma nagement of their childs pain. This prompted an editors note positing that this may even be a form of child abuse worthy of investigation. Perhaps this dissonance is one of the reasons that have motivated researchers to better understand infant pain. O nly recently has there been any attempt to quantify the physiological measures that express infant pain. Parents in most societies serve as the other half of the

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44 autonomous unit, the parent -child dyad. A respect for infant parent autonomy would require tha t both parental satisfaction and actual measures of infant pain come together to provide a complete picture of infant well being Summary Pain has been found to have detrimental effects compromising infant growth, development, and health (Boss, 2002). Nurs ing participation in pain management is crucial to achieve positive health outcomes for infants who experience repetitive or severe pain. Considerations in nursing and pain management were discussed including factors impacting nursing assessment of pain. Factors examined included the infant (medical diagnosis, age, behavior, expression, physiology), parent (parental participation), and nurse (knowledge, experience, attitude, workload) (Twycross, 2007; Kane, 2007). Further investigation for practice issues (lack of knowledge, attitude, and workload) is needed for the clinical setting. Pain assessment tools designed to assess infant pain were discussed including the PIPP, CRIES, NIPS, N -Pass, PAT, and SUN (American Academy of Pediatrics, 2009) A multidime nsional pain assessment tool appropriate for chronologic age that measures both physiologic and behavioral components was recommended (American Academy of Pediatrics Policy Statement, 2006) The nature of different types of pain was also discussed, i.e., p rocedural versus postoperative (American Academy of Pediatrics, 2009). The multidimensional pain assessment tool chosen for this study was the NIPS (Neonatal Infant Pain Scale) which measures respiratory patterns as a physiologic indicator, and facial ex pression, cry, movement of arms and legs, and state of arousal as behavioral indicators. Procedural pain, such as heel sticks, is the type of pain recommended to be assessed with the NIPS (Duhn, & Medves, 2004). The NIPS was chosen as the pain assessment tool for this study due to the multidimensional ability (physiologic and behavioral), age considerations (infant), type of pain recommendation (procedural), and ease of use.

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45 In summation, this strongly supports that the assessment and treatment of infant pain continues to be multifactorial, inconsistent, and at times insufficient for pain alleviation Hospitalized infants continue to endure a multitude of invasive and potentially painful procedures ((DApolito, 2006; Carbajal, et. al., 2008). Management of neonatal and infant pain is important not only to provide comfort, but also to prevent long-lasting negative consequences related to painful experiences (Grunau, 2002). Pain has been found to have detrimental effects that compromise growth, development, and health (Boss, 2002). Repeated pain may lead to negative physiologic outcomes further compromising the health of the infant For intubated infants who routinely encounter painful conditions, the relief of pain can potentially improve the h ealth and development of seriously ill infants. Given the lack of literature addressing the assessment and treatment of pain in intubated infants, nurse scientists must generate more evidence to fill th is gap. Further study of nonnutritive sucking and sucr ose in intubated infants on measurable clinical outcomes following painful episodes is needed. The following chapter will discuss a repeated measures cross -over design study examining the effects of nonnutritive sucking combined with sucrose induced anal gesia on heart rate, oxygen saturation, and pain behaviors as measured by the Neonatal Infant Pain Scale in intubated infants. Nursing participation in the assessment and treatment of infant pain management is crucial to achieve positive health outcomes f or infants who experience repetitive or severe pain. The fol lowing study outlines this work.

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46 Painful Stimulus NNS with Sucrose (Treatment Group) No NNS (Control Group) Transmission of Painful Sensation Pain Response Adverse Outcome Positive Outcome Figure 2 1. Concept Map

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47 CHAPTER 3 METHODS Design The purpose of this study was to determine the effect of nonnutritive sucking (NNS) combined with sucrose -i nduced analgesia on heart rate, oxygen saturation, and pain behaviors (measured by the Neonatal Behavioral Pain Scale (NIPS)) in 32 to 42 week intubated infants Subjects and Setting Using a repeated measures cross -over design (Maxwell & Delaney, 1990), 14 infants were chosen by convenience from a 112 bed (sixty bed level two, fifty-two bed level three) neonatal intensive care unit population located in central Florida. There were 14 infants, all of which were diagnosed with respiratory distress. It was a diverse sample in terms of ethnicity: 5 African -American (35.7%) 4 Caucasian (28.6%) 4 Hispanic (28.6%) and 1 Asian (7.1%) Nine infants were male (64.3%) and 5 were female (35.7%) The mean gestational age was 35.14 (SD = 2.85) with a mean age sinc e birth of 4.79 days (SD = 5.58; Range: 19). Weight ranged from 1 7 69 grams to 3642 grams. Mean birth weight was 2351.86 grams (SD = 805.35). Each subject served as their own control for a total of 28 observations. Each subject was monitored before, du ring, and after a required, routine heel stick. Power Analysis In order to achieve 80% power with an alpha of 0.05 using an effect size of 0.75 (based on the means 7.7 and 4.3, standard deviation 3.9 from Brovedani Montico, Shadlow, Strajn, and Demarini ( 2007)), it was determined that a minimum of 14 subjects per observational condition were needed. Inclusion criteria were as follow s : Greater than or equal to 32 weeks gestation at birth and less than or equal to 42 weeks of gestational age

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48 Intubated Recei ving assisted mechanical ventilation Clinically demonstrate a sustained suck reflex Require routine heel stick as part of medical care 30 minute uneventful period prior to the heel stick Exclusion criteria were as follows: Medication for sedation admini stered within 2 hours prior to heel stick to avoid the effect of additional opioid or decreased level of consciousness that blunts response to painful stimulus History of nondevelopmental neurological deficits should have ability to suck and respond to sti mulus Diabetes unable to receive sucrose if susceptible to hyperglycemia Necrotizing enterocolitis gut must remain empty; oral sucrose is contraindicated This study was approved by the Internal Review Boards of Winnie Palmer Hospital for Women and Babies, Orlando Healthcare in Orlando, Florida, and the University of Florida, in Gainesville, Florida. Variables Independent Variable Non -nutritive sucking (NNS) with the addition of sucrose was the independent variable. During the treatment condition (NNS wit h sucrose), the infant was given a pacifier with the nipple coated in 1ml of a 24% sucrose solution, Sweet Ease. The infant was given the coated nipple 2 minutes prior to the painful procedure (heel stick). The 2 -minute time interval for optimal efficacy is thought to coincide with the endogenous opioid release triggered by taste (Gibbins & Stevens, 2001). The rubber shield siding of the pacifier was removed from one side to allow a more comfortable fit between the nipple and the endotracheal tube. The nip ple was kept in the infants mouth for the observation period even when the infant was not sucking

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49 Dependent Variable The dependent variables were heart rate (recorded by a cardiac monitor), oxygen saturation (recorded by a peripherally attached transcutaneous oxygen saturation monitor), and the infants behavioral response (as measured by the NIPS Behavioral Pain Scale ). Heart R ate A change in heart rate represents an increase or decrease in agitation, energy expenditure, and/or pain ( Woodson & Hamilton, 1986; Miller & Anderson, 1993) A mounted EKG Phillips Intellivue MP70 Neonatal Monitor was used by the research er to obtain the heart rate when the audible beep on the prerecorded tape alarmed. The prerecorded tape alarmed with an audible beep every thirty seconds. The researcher wore an earpiece to hear the alarm. Oxygen S aturation A change in the oxygen saturation represent s an increase or decrease in transcutaneous oxygen tension (TcPaO2) reflective of a change in respiratory function. The same Phil lips Intellivue MP70 Neonatal Monitor was used by the researcher to obtain the oxygen saturation when the audible beep on the prerecorded tape alarmed. NIPS Behavioral Pain Scale The NIPS Behavioral Pain Scale (Appendix A) measures pain behavior in term and preterm infants who may not be able to verbalize the presence or severity of pain (Duhn & Medves, 2004). The multidimensional tool scores procedural pain by assessing five categories of behavior: facial expression, cry, breathing patterns, limb movement, and arousal. Each category is scored on a 0 1 scale, except cry which is scored 0 2. In the category facial expression, 0 = relaxed muscles (restful face, neutral expression), and 1= grimace (tight facial muscles, furrowed brow, chin, jaw). In the cry cat egory, 0 = no cry (quiet, not crying), 1 = whimper (mild moaning intermittent), and 2 = vigorous cry (with the intubated infant noted as obvious mouth and facial movement). In the breathing patterns category, 0 = relaxed (usual pattern for this infant), an d 1 =

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50 change in breathing (retractions, irregular, faster than usual, gagging, holding breath). The limb movement category is divided into arms and legs. In the arms category 0 = relaxed or restrained (no muscular rigidity; occasional random movement of ar ms), and 1 = flexed or extended (tense straight arms, rigid and/or rapid extension, flexion). In the legs category 0 = relaxed or restrained (no muscular rigidity; occasional random leg movement) and 1 = flexed or extended (tense, straight legs; rigid and/ or rapid extension, flexion). In the arousal state category, 0 = sleeping or awake (quiet, peaceful sleeping or alert random leg movement, and 1 = fussy (alert, restless, and thrashing). The total score is between 0 7. A score of 3 or greater indicates pai n. In previous studies the psychometric properties of the NIPS Behavioral Pain Scale revealed interrater reliability (Pearsons correlations 0.92 to 0.97), internal consistency (Cronbachs alphas 0.87 to 0.95), concurrent validity (correlations 0.53 to 0.84 when compared to visual analogue scale), and construct validity (change in pain scores over time was seen with main effect of time being statistically significant, F = 18.97, P < 0.001) (Duhn & Medves, 2004). These tests were performed in both preterm an d full -term neonates (Franck, Greenberg, & Stevens, 2000). In the present study, inter rater reliability was conducted between the researcher and a second rater who was an experienced neonatal intensive care registered nurse well versed in NIPS scoring. I nter rater reliability was assessed by having the same second rater score 100% of the procedures ( see Table 3 1 ). The researcher scored the heart rate, oxygen saturation, and the NIPS scores. The second rater scored the NIPS scores. The second rater stoo d across from the first rater, but within view of the infant. The proportion of agreements between the researcher and second rater was 98.2%.

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51 Painful Event The painful event w as a scheduled heel stick for blood sample obtainment performed by the regis tered nurse. A total of six different registered nurses with greater than two years of neonatal intensive care unit nursing experience performed the heel stick. The steps of the heel stick include d: 1) cleaning the heel with an antiseptic immediately prior to the heel stick (alcohol if greater than 2 weeks of age, or betadine swab followed with sterile water prep for infants less than 2 weeks of age (Folk, 2007) ), 2) holding the extremity firmly, 3) puncturing the inner outside edge of the heel with a steri le heel stick lancet, and then 4) compress ing the heel to facilitate blood collection. The heel stick w as not in a cluster of other events. It occur red after a 30minute uneventful period. In order to maintain equality between the two groups, n o differenc e in the amount of investigator contact with the infants was noted between the two groups to maintain equality of treatment Procedure Following informed consent, the infants w as randomly assigned to receive first either the NNS with sucrose (treatment) c ondition ( see Table 3 2 ) or the ONNS (control) condition (see Table 3 3 ). While the infant remained in their assigned incubator bed, t he heart rate and oxygen saturation (TcPaO2) w as measured in 30 -second intervals during a 5 -minute baseline period, during a heel stick, and during a 5 -minute follow up period. The behavioral state score (NIPS Behavioral Pain Scale) was measured in one minute intervals. Heart rate and oxygen saturations were collected every 30 seconds from digital recordings at the bedside monitor. Using a tape recorder (Sony Corp., Japan, model 1C Recorder 1CD 325) an audible beep was produced every 30 seconds on a prerecorded tape prompting the time for data collection. The researcher wore earplugs to eliminate sound interference. The NIPS

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52 scores were collected every minute. Data w as collected and transcribed onto data collection sheets (Appendix B and C) by the same researcher and second rater Treatment Condition In the treatment condition (NNS) with sucrose following the 5 -minute baseline period, the infant was given a pacifier coated by a maximum dose of 1ml of a 24% sucrose solution (Sweet Ease). The pacifier was prepared for administration by dipping the entire nipple in the cup of sucrose solution and then placing it into the infants mouth on the top of the tongue. The pacifier w as kept in the infants mouth 2 minutes before the heel stick, during the heel stick, and during the 5 -minute follow up period even when the infant was not sucking. Control Condition In the control condition (ONNS) the heart rate and oxygen saturation (TcPaO2) w ere measured in thirty second intervals during a five -minute baseline period, during a heel stick, and during a five -minute follow up period. The behavioral state (NIPS score) was measured in one minute intervals. Risks and Benefits There was no risk associated with this study for the treatment (NNS with sucrose) or control groups The lack of use of this intervention may be due to the misinterpretations or attitude regarding pain, the nurses k nowledge, or work experience. The risk for the control group (ONNS) was that they will not receive the potential comforting effect of NNS with sucrose. Subjects could withdraw at any time due to parental or legal guardian wishes, or the infants physical condition. No subjects withdrew from the study. Each subject w as assigned a code to assure anonymity. Demographic information of the subject include d age, gender, ethnicity, diagnosis, birth weight, length of admission, and any

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53 surgical history. Confiden tiality was maintained throughout. Records were kept in a locked cabinet in the researchers locked office. Data Analysis D ata analysis w as performed utilizing SPSS software. Data analysis include d descriptive statistics on demographic data reporting mea n and a standard deviation. For heart rate, oxygen saturation, and the Neonatal Infant Pain Scale (NIPS) the mean of each 30-second period w as analyzed. These data points were divided into the following four phases. Phase 1 was defined as the baseline an d wa s the mean of the first 10 observations. Phase 2 was defined as NNS (treatment condition) or c ontinued b aseline (control condition) and was the mean of the next 4 observations Phase 3 was the mean of the f irst five post -heel stick observations P h ase 4 was the mean of the l ast five post -heel stick observations A repeated -measures analysis of variance (ANOVA) w as performed (using the means of each 30-second period of heart rate, oxygen saturation, and NIPS score) to answer each of the research hyp otheses (Hair, Anderson, Tatham, & Black, 1998). Hypothesis 1 Infants will have lower mean heart rates in the NNS condition with sucrose (treatment condition) during a heel stick than those infants not offered NNS with sucrose (control condition). Hypothes is 2 Infants will have higher mean oxygen saturations in the NNS condition with sucrose (treatment condition) as measured by noninvasive pulse oximetry during a heel stick than those infants not offered NNS with sucrose (control condition ).

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54 Hypothesis 3 In fants will have lower NIPS scores in the NNS condition with sucrose (treatment condition) during a heel stick than those infants not offered NNS with sucrose (control condition).

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55 Table 3 1 Inter rater Reliability of Observations NNS Data GA Age Race Se x Weight 1st Obs. 2nd Obs. IRR 1 st /2 nd 1 41 wk 6 days Black Male 3030 gm ONNS NNS 100% 2 37 wk 13 days Hispanic Female 3298 gm ONNS NNS 100% 3 36 wk 9 days White Female 2240 gm NNS ONNS 100% 4 32 wk 1 day Black Male 769 gm NNS ONNS 91.70% 5 34 wk 19 d ays Black Male 1359 gm ONNS NNS 100% 6 38 wk 0 days Black Male 3191 gm ONNS NNS 100% 7 38 wk 2 days Hispanic Female 3642 gm ONNS NNS 91.70% 8 34 wk 1 day White Male 1814 gm ONNS NNS 100% 9 37 wk 1 day Hispanic Male 2612 gm NNS ONNS 100% 10 32 wk 1 day Asian Male 2286 gm NNS ONNS 100% 11 33 wk 5 days White Female 2275 gm ONNS NNS 91.70% 12 32 wk 5 days Hispanic Male 1604 gm NNS ONNS 100% 13 32 wk 1 day Black Female 2166 gm NNS ONNS 100% 14 36 wk 3 days White Male 2535 gm NNS ONNS 100% Note. 1st Ob s = First Observation Condition (NNS or ONNS); 2nd Obs. = Second Observation Condition (NNS or ONNS); IRR 1st/2nd = Mean p ercentage agreement of first inter rater and second inter rater of all heart rate readings, oxygen saturation readings, and NIPS scor es

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56 Table 3 2 Treatment Condition Observation f or NNS with S ucrose Age in Days Heart Rate (HR) O2 Sats % (O2 % ) NIPS Baseline Phase 1 min ute HR 1a 30 seconds HR 1b 60 seconds O2% 1a 30 seconds O2% 1b 60 seconds NIPS 1 minute 2 min ute HR 2a 30 s econds HR 2b 60 seconds O2% 2a 30 seconds O2% 2b 60 seconds NIPS 2 minute 3 min ute HR 3a 30 seconds HR 3b 60 seconds O2% 3a 30 seconds O2% 3b 60 seconds NIPS 3 minute 4 min ute HR 4a 30 seconds HR 4b 60 seconds O2% 4a 30 seconds O2% 4b 60 seconds NIP S 4 minute 5 min ute HR 5a 30 seconds HR 5b 60 seconds O2% 5a 30 seconds O2% 5b 60 seconds NIPS 5 minute NNS Introduction Phase 1 min ute HR 6 a 30 seconds HR 6 b 60 seconds O2% 6 a 30 seconds O2% 6 b 60 seconds NIPS 6 minute 2 min ute HR 7 a 30 seconds HR 7 b 60 seconds O2% 7 a 30 seconds O2% 7 b 60 se c onds NIPS 7 minute Heel S tick Phase After Heel Stick Phase 1 min ute HR 8 a 30 seconds HR 8 b 60 seconds O2% 8 a 30 seconds O2% 8 b 60 seconds NIPS 8 minute 2 min ute HR 9 a 30 seconds HR 9 b 60 seconds O2% 9 a 30 seconds O2% 9 b 60 seconds NIPS 9 minute 3 min ute HR 10a 30 seconds HR 10 b 60 seconds O2% 10a 30 seconds O2% 10 b 60 seconds NIPS 10 minute 4 min ute HR 11a 30 seconds HR 11 b 60 seconds O2% 11a 30 seconds O2% 11 b 60 seconds NIPS 11 minute 5 min ute HR 12a 30 seconds HR 12 b 60 seconds O2% 12a 30 seconds O2% 12 b 60 seconds NIPS 12 minute

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57 Table 3 3 Control Condition Observation for ONNS Age in Days Heart Rate O2 Sats % NIPS Baseline Phase 1 min ute HR 1a 30 seconds HR 1b 60 seconds O2% 1a 30 seconds O2% 1b 60 seconds NIPS 1 minute 2 min ute HR 2a 30 seconds HR 2b 60 seconds O2% 2a 30 seconds O2% 2b 60 seconds NIPS 2 minute 3 minute HR 3a 30 seconds HR 3b 60 seconds O2% 3a 30 seconds O2% 3b 60 seconds NIPS 3 minute 4 minute HR 4a 30 seconds HR 4b 60 seconds O2% 4a 30 seconds O2% 4b 60 seconds NIPS 4 minute 5 minute HR 5a 30 seconds HR 5b 60 seconds O2% 5a 30 seconds O2% 5b 60 seconds NIPS 5 minute ONNS Phase 1 minute HR 6 a 30 seconds HR 6 b 60 seconds O2% 6 a 30 seconds O 2% 6 b 60 seconds NIPS 6 minute 2 minute HR 7 a 30 seconds HR 7 b 60 seconds O2% 7a 30 seconds O2% 7 b 60 seconds NIPS 7 minute Heel Stick Phase After Heel Stick Phase 1 minute HR 8 a 30 seconds HR 8 b 60 seconds O2% 8 a 30 seconds O2% 8 b 60 seconds NI PS 8 minute 2 minute HR 9 a 30 seconds HR 9 b 60 seconds O2% 9 a 30 seconds O2% 9 b 60 seconds NIPS 9 minute 3 minute HR 10a 30 seconds HR 10 b 60 seconds O2% 10a 30 seconds O2% 10 b 60 seconds NIPS 10 minute 4 minute HR 11a 30 seconds HR 11 b 60 seconds O2% 11a 30 seconds O2% 11 b 60 seconds NIPS 11 minute 5 minute HR 12a 30 seconds HR 12 b 60 seconds O2% 12a 30 seconds O2% 12 b 60 seconds NIPS 12 minute

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58 CHAPTER 4 RESULTS This research was conducted with 14 hospitalized intubated infants who were 32 to 41 weeks gestational age at birth (mean 35. 14 weeks gestational age, standard deviation 2.85) ranging from 0 to 19 days old (mean 4.79 days standard deviation 5 58) at study onset. Each infant was intubated and receiving assisted mechanical ventilation. The purpose of this research was to determine the effect of nonnutritive sucking (NNS) combined with sucrose -induced analgesia on heart rate, oxygen saturation, and pain behaviors (measured by the Neonatal Infant Pain Scale) before, during, and after a p ainful event (heel stick) in this population. The following hypotheses were tested in this research: 1 Infants will have lower mean heart rates in the NNS condition with sucrose (treatment condition) following a heel stick than infants not offered NNS with sucrose (control condition) 2 Infants will have higher mean oxygen saturations in the NNS condition with sucrose (treatment condition) as measured by noninvasive pulse oximetry following a heel stick than those infants not offered NNS with sucrose (con trol condition) 3 Infants will have lower NIPS scores in the NNS condition with sucrose (treatment condition) following a heel stick than those infants not offered NNS with sucrose (control condition) S ample Participant Demographics There were 14 infants a ll of which were diagnosed with respiratory distress. It was a diverse sample in terms of ethnicity. Nine infants were males (64.3%) and 5 were female (35.7%). The mean gestational age was 35.14 ( SD = 2.85) with a mean age in days of 4.79 (SD = 5.58; Ra nge: 19). Mean IMV was 23.79 (SD = 6.18). Mean PEEP was 4.64 (SD = 0.84). The mean APGAR ratings at 1 minute were 5.57 (SD = 2.65).

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59 Thirteen of the infants were delivered by cesarean section (92.9%), and one was not (7.1%). Observations There were two periods when data was collected through observation sessions. They are referred to as NNS (treatment group) and non -NNS (control group). The only difference between the two conditions was the introduction of NNS with sucrose in the treatment group prior to the heel stick. Observation sessions were conducted, in average, within 24 hours of each other. The observation sessions were counterbalanced. For example, the NNS session was conducted first followed by the nonNNS session. In the analyses th at follow, the EXPCONDITION variable differentiates the NNS and non NNS conditions. There were three dependent variables: heart rate, oxygen saturation, and NIPS scores. In each observation session, there were twenty -four heart rate observation points twenty -four oxygen saturation observation points, and twelve NIPS observation points H eart Rate In both the NNS and non NNS condition there were 24 heart rate observation points (see Table s 3 2 and 3 3) In the non NNS condition, the first 14 observat ion points were baseline observations of resting infant heart rate. The next 10 observations points were infant heart rate post heel stick. In the NNS condition, the first 10 observation points were baseline observations of resting infant heart rate. The next 4 observation points were observations of heart rate when NNS with sucrose was introduced. The next 10 observation points were post -heel stick. Oxygen Saturation In both NNS and non NNS sessions, there were 24 oxygen saturation observations (see Tab les 3 2 and 3 3) Identical to the heart rate observation method, the first 14 observation points in the nonNNS condition provided baseline oxygen saturation measurements. The last 10

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60 observations were post -heel stick measurements of oxygen saturation. In the NNS condition, the first 10 observations were baseline measurements of oxygen saturation, the next 4 observations measured oxygen saturation during NNS, and the final 10 data points represented oxygen saturation post -heel stick. NIPS S cores In cont rast to the 24 heart rate and oxygen saturation measurements, there were only 12 NIPS score observations in each session (see Tables 3 2 and 33) In both the NNS and nonNNS conditions, the first five NIPS scores were baseline measurements while the last seven NIPS scores were post -heel stick measurements. R esults Visual Analyses Figures 4 1 through 4 14 depict heart rate and blood oxygenation for each infant pre and post heel -stick across experimental and control conditions. The charts have dual yaxes displaying both heart rate and oxygen saturation observations. Figure 4 15 displays mean heart rates across control and NNS conditions. Figure 4 16 displays oxygen saturation levels across control and NNS conditions. Table 4 1 1 displays the mean phase differences in heart rate and oxygen saturation in the experimental and control conditions. Aggregated Data Analyses Two -factor within subjects ANOVA For both the experimental and control conditions, there were 24 data points (see Tables 3 2 and 3 3) FACT OR 1 (EXPCONDITION). Each baby was exposed to a control and intervention condition (Factor 1). The treatment factor had 2 levels: Control (non NNS) Experimental (NNS)

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61 FACTOR 2 (PHASE): These data points were divided into the following four phases; Phase 1 : Baseline Defined as the mean of the first 10 observations Phase 2: NNS (intervention condition) or Continued Baseline (control condition) Defined as the mean of the next 4 observations Phase 3: First five post heel stick observations Defined as the mean of the first five observations post -heel stick Phase 4: Last five post -heel stick observations Defined as the last five observations post -heel stick For Factor 2 (PHASE), analyses were conducted on the means for each of the four phases identified above. B y aggregating observations into means, and then running the ANOVA on the phase means, the problem of having an unacceptably small ratio of observations to subjects is avoided. Also, there is less concern about serial dependency of data, although this is a lways a concern in repeated measures ANOVA. This analysis permits examination of three different effects: main effect for TREATMENT, main effect for PHASE, and whether there is at TREATMENT*PHASE interaction. Heart Rate Heart rate means and standard deviations for each phase are displayed below. HRCPhase1 is the mean of the first ten heart rate observations in the control or nonNNS Phase1 condition. HRCPhase2 is the mean of the next four heart rate observations in the nonNNS condition (effectively, a n extension of baseline). HRCPhase3 is the mean of the first 5 heart rate observations in the non NNS condition. HRCPhase4 is the mean of the last 5 heart rate observations in the non NNS condition. HRIPhase1 is the mean of the first 10 baseline observations in the NNS condition. HRIPhase2 is the mean of the 4 observations during introduction of NNS. HRIPhase3 is the mean of the first 5 observations post -heel stick.

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62 HRIPhase4 is the mean of the last 5 observations post -heel stick. It is of note that the h eart rates in Phases 1 and 2 of both the control and intervention phases are similar. However, the heart rates in Phases 3 and 4 of both the control and intervention phases are greater in comparison. The heart rate mean in the intervention Phase 4 (135.64) is less than the heart rate mean in the control Phase 4 (150.64) suggesting the return to baseline was occurring in the intervention phase. ANOVA Results This is a 2 x 4 within -subjects factorial ANOVA. There are two levels for EXPCONDITION (1 = Control or non NNS; 2 = NNS). There are four levels for PHASE (defined above) ANOVA Interpretation 1 The factor EXPCONDITION F (1, 13) = 46.65, p 2 = .78. There is a strong main effect for the exper imental condition with about 78% of the variation in mean scores due to the assignment to condition. 2 The factor PHASE F (3, 39) = 101.73, p 2 = .89. There is a strong main effect for PHASE with about 89% of the variation in mean scores du e to phase. It was expected that there would be differences in mean scores across phases when the NNS and non NNS conditions were collapsed. The four phases were different from one another independent of the NNS and nonNNS condition. 3 The interaction effe ct EXPCONDITION*PHASE F (3.39) = 24.69, p 2 = .66. There is a strong interaction effect with about 65% of the variation due to the interaction effect. The difference in mean scores for experimental condition (NNS vs. non NNS) depends on the phase. Even with few subjects, the int eraction effect was evident. At this point there are statistically significant effects. The output below breaks those effects down with regard to EXPCONDITION, PHASE, and the INTERACTION EFFECT

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63 Experimental Effects (Heart Rate) Main Effect for EXPCONDITIO N (Heart Rate) The m e an and standard deviation for nonNNS (1) and NNS (2) conditions, collapsing across the phase is displayed below. The pairwise comparisons are displayed below for the main effect of the two conditions using Bonferroni adjustment. This table indicates that the main effect for condition reflects a significant difference ( p < .001) between the two conditions. Main Effect for PHASE (Heart Rate) The results for PHASE are displayed below The first box shows the mean heart rate scores for PHASE irrespective of level of EXPCONDITION (i.e., non NNS and NNS): It was expected that heart rate would increase during Phase 3 observations (the phase immediately after the heel stick) irrespective of whether the infant was in the NNS or nonNNS co ndition. The pairwise comparisons are displayed below for the main effect of the four phases using Bonferroni adjustment. Phases 3 and 4 were significantly different from Phases 1 and 2. In addition, Phase 3 and Phase 4 were significantly different from one another, suggesting recovery was occurring. This illustrates the importance of breaking down the first five post -heel stick observations from the last five post -heel stick observations. Interaction Effect: EXPCONDITION*PHASE (Heart Rate) The means for each experimental condition and phases are provided below : The interaction effect can be seen visually. The phase means for Phases 3 and 4 are significantly different from one another. The phase means for Phases 1 and 2 are not.

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64 Bonferroni -corrected paired sample t -tests contrasted the means for the phases and confirmed the interaction effect. Heart rate means for the NNS and non NNS baseline sessions we re not significantly different from each other. For the first baseline phase, t (13) = .74, ns For the second baseline phase, t (13) = 1.26, ns However, heart rate means for the NNS and non NNS post heel stick phases were significantly different. For t he first post -heel stick phase, t (13) 2 = .85. For the second post -heel stick phase, t 2 = .86. Thus, the effect is entirely found in the post -heel stick phases and is consistent with the experimental hypotheses. The large effect sizes are interpreted as follows: In the first post -heel stick comparison, 85% of the variation in differences between heart rates is accounted for by condition (i.e., the manipulation of the independent variable, NNS). In the second pos t -heel stick comparison, 86% of the variation in differences between heart rates is accounted for by the independent variable. Both are very robust effects. Latency to Heart Rate Recovery Given that mean heart rate differences were robust, a second questi on is whether the infants differed across sessions in their recovery latencies. In other words, did the infants in the NNS condition recover to baseline heart rate faster than the infants in the control condition? Table 4 12 shows latency to recovery fo r each infant. See the note at the bottom of the table for interpretation. The point of the analysis was to create a confidence interval around the observed heart rate mean during baseline and then identify the first heart rate observation post heel stick that may be located within the baseline confidence interval. Note that none of the nonNNS heart rates fell within the confidence interval, whereas 10 of the 14 NNS infant heart rates did, suggesting a much shorter latency in recovery time. Figure 4 15 also displays shorter

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65 latency to recovery times. Thus, there is a statistically significant interaction effect in the hypothesized direction for heart rate, and latency to recovery times are shorter. Oxygen Saturation Two Factor Within Subjects ANOVA Phas es were arranged as per the heart rate data Oxygen saturation means and standard deviations for each phase are displayed below OXSATCPhase1 is the mean of the first ten oxygen saturation observations in the control or non NNS Phase1 condition. OXSAT CPhase2 is the mean of the next four oxygen saturations in the nonNNS condition (effectively, an extension of baseline). OXSATCPhase3 is the mean of the first 5 oxygen saturation observations in the non NNS condition. OXSATCPhase4 is the mean of the las t 5 oxygen saturation observations in the nonNNS condition. OXSATIPhase1 is the mean of the first 10 baseline observations in the NNS condition. OXSATIPhase2 is the mean of the 4 observations during the introduction of NNS. OXSATIPhase3 is the mean of t he first 5 observations post heel stick. OXSATIPhase4 is the mean of the last 5 observations post -heel stick. It is of note that the oxygen saturations in Phases 1 and 2 of both the control and intervention phases are similar. However, the oxygen satura tions in Phases 3 and 4 of both the control and intervention phases are less in comparison. The oxygen saturation mean in the intervention Phase 4 (97.68) is greater then the oxygen saturation mean in the control Phase 4 (94.30) suggesting the return to b aseline was occurring in the intervention phase. ANOVA Interpretation The factor EXPCONDITION F (1,13) = 19.09, p 2 = .59. There is a strong main effect for the experimenta l condition with about 59% of the variation in mean scores due to the assignment to condition.

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66 The factor PHASE F (3, 39) = 53.83, p 2 = .80. There is a strong main effect for PHASE with about 80% of the variation in mean scores due to ph ase. The interaction effect EXPCONDITION*PHASE F (3.39) = 22.28, p 2 = .63. There is a strong interaction effect with about 63% of the variation due to the interaction effect. Even with low power (few subjects), the interaction effect was evident. At this point there are statistically significant effects. Like the heart rate data, these results show a main effect for EXPCONDITION, PHASE, and the interaction effect EXPCONDITION PHASE. Notice that the effect sizes (partial eta squared) a re similarly large. The output below breaks those effects down with regard to EXPCONDITION, PHASE, and the INTERACTION EFFECT Experimental Effects (Oxygen Saturation) Main Effect for EXPCONDITION (Oxygen Saturation ) The mean and standard deviation for non NNS (1) and NNS (2) conditions, for EXPCONDITION after collapsing across phases is displayed below: The pairwise comparisons are displayed below for the main effect of the two conditions using Bonferroni adjustment. This table indicates that the main effect for condition reflects a significant difference ( p < .001) between the two conditions. Main Effect for PHASE (Oxygen Saturation). The results for PHASE are displayed below. The first box shows the mean oxygen sat uration scores for PHASE irrespective of level of EXPCONDITION (i.e., non NNS and NNS). Notice that there is a change in Phase 3 in that oxygen saturation levels drop. In Phase 4, it appears the mean is beginning to return back to baseline levels (increase from 94.5 to 95.9).

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67 The pairwise compari sons are displayed to follow for the main effect of the four phases using Bonferroni adjustment. Like heart rate, Phases 1 and 2 are significantly different from Phases 3 and 4. In addition, Phases 3 and 4 are significantly different from each other. Int eraction Effect: EXPCONDITION PHASE (Oxygen Saturation) The means for each experimental condition and phases are provided below As depicted earlier, the oxygen saturation means and plot show where the interaction effect occurs. Phase 3 and 4 means ar e significantly different from one another across experimental conditions. The phase means for Phases 1 and 2 are not. Four Bonferroni corrected paired -samples t -tests contrasted the means for the NNS and non NNS conditions. As with the heart rate analysi s, baselines oxygen saturation means for the NNS and non -NNS conditions were not significantly different from one another. For the first baseline phase, t(13) = 1.69, ns. For the second baseline phase, t(13) = .91, ns. In contrast, paired sample t tests for the post -heel stick means were statistically significant. For the first post -heel stick found in Phase 3 and Phase 4, suggesting a therapeutic advantage for the NNS condition with regard to oxygen saturation levels. The effect sizes are interpreted as follows: In the first post -heel stick comparison, 65% of the variation in differences betwe en oxygen saturations is accounted for by condition (i.e., the manipulation of the independent variable, NNS). In the second post -heel stick comparison, 69% of the variation in differences between oxygen saturation is accounted for by the independent vari able. Both are very robust effects.

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68 Latency to Oxygen Saturation Recovery In many ways, the results for oxygen saturation recovery mimic results for heart rate recovery. Table 13 shows latency to recovery statistics for oxygen saturation for each infant. Note that in the NNS condition, 9 of the 12 infants achieved an oxygen saturation level during recovery that was greater than the lower limit of the 95% confidence level for the baseline mean. Conversely, none of the infants during the nonNNS (control) condition achieved an oxygen saturation level higher than the lower limit of the 95% confidence level for the baseline mean. Further, the delta value for the z -scores for the highest observed oxygen saturation level during NNS and non -NNS conditions was u niformly positive, meaning that the treatment effect was always in the therapeutic direction. In two cases, delta could not be calculated since there was no variation in oxygen saturation during nonNNS baseline (and the corresponding 95% confidence inter val could not be calculated). NIPS Scores In contrast to the heart rate and oxygen saturation measurements, there were only 12 NIPS score observations. In both the NNS and nonNNS conditions, the first five scores were baseline measurements (pre heel stic k). The last seven NIPS scores were post -heel stick measurements. The pre heel stick means and standard deviation NIPS scores in both the control (NIPSCPre) and intervention (NIPSIPre) conditions were less than the post heel stick means and standard devi ation NIPS scores. Figure 4 17 displays mean NIPS scores across control and NNS conditions. ANOVA Interpretation These results show a main effect for PHASE, but not for EXCONDITION or EXPCONDITION*PHASE.

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69 1 The factor EXPCONDITION F (1, 13) = 2.46, p =.140 ns 2 = .16. There is a weak main effect for the experimental condition with about 16% of the variation in mean scores due to the assignment to condition. 2 The factor PHASE F (1, 13) = 697.88, p 2 = .98. There is a strong main effe ct for PHASE with about 98% of the variation in mean scores due to phase. 3 The interaction effect EXPCONDITION*PHASE F (1.13) = 1.95, p = .186 ns 2 = .13. The p value is not significant. There is a weak interaction effect with about 13% of the v ariation due to the interaction effect. Factors that May Mediate the Effect Birth Weight There was a relatively strong correlation between birth weight (in grams) and the size of the change effect reported in the far right column for both heart rate and oxygen saturation in Tables 12 and 13. For heart rate, recall that the value of delta is the z -score difference for lowest achieved heart rate in an infant across NNS and nonNNS conditions. Thus, a large negative delta value indicated a large standardized difference in heart rate recovery in the therapeutic direction. Birth weight correlated r (12) = 0.62, p = 0.17 with the delta value for heart rate recovery, meaning that higher birth weights were associated with greater therapeutic effect (i.e., lower heart rates relative to baseline in the NNS condition). The effect was not as large for oxygen saturation and the result was not statistically significant, r (12) = .27, ns FiO2 The other variable that seems to be strongly related to treatment effect is FiO2, fraction of inspired oxygen. FiO2 had a borderline relationship to the heart rate effect, r (12) = .511, p = .06 and was significantly related to the oxygen saturation effect, r (12) = .59, p = .05.

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70 Table 4 1. Descriptive Statistics of Heart Rate Mean Std. Deviation N HRCPhase1 135.1214 9.28507 14 HRCPhase2 136.8750 10.12221 14 HRCPhase3 155.1429 7.55836 14 HRCPhase4 150.6429 7.53257 14 HRIPhase1 133.8786 7.65428 14 HRIPhase2 134.3750 6.59162 14 HRIPhase3 141.0857 8.27553 14 HRIPhase4 135 .6429 7.71140 14 Table 4 2 Mauchlys Test of Sphericity of Measure: MEASURE 1 Within Subjects Effect Mauchlys W Approx Chi Square Df Sig Greenhouse Geisser Epsilon* HuynhFeldt Lower bound ExpCondition 1.000 .000 0 1.000 1.000 1.000 Phase 410 10.457 5 .064 .701 .839 .333 ExpCondition*Phase .323 13.249 5 .022 .608 .703 .333 Tests the null hypothesis that the error covariance matrix of the orthonormalized transformed dependent variables is proportional to an identity matrix. a. May be used to adjust the degrees of freedom for the averaged tests of significance. Corrected tests are displayed in the Tests of Within-Subjects Effects table. b. Design: Intercept Within Subjects Design: ExpCondition + Phase + ExpCondition Phase The Mauchlys tes t was negative for Phase suggesting no violation of the sphericity assumption. 2 (5) = 10.46, p > .05. Table 4 3 Within Subjects Factors of Measure: MEASURE 1 Exp Cond. Phase Dependent Variable 1 1 HRCPhase1 2 HRCPhase2 3 HRCPhase3 4 HRCPhase4 2 1 HRIPhase1 2 HRIPhase2 3 HRIPhase3 4 HRIPhase4

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71 Table 4 4 Tests of Within -Subjects Effects Measure: MEASURE 1 Source Type III Sum of Squares Df Mean Square F Sig Partial Eta Squa red ExpCondition Sphericity Assumed 1882.720 1 1882.720 46.652 .000 .782 Greenhouse Geisser 1882.720 1.000 1882.720 46.652 .000 .782 Huynh Feldt 1882.720 1.000 1882.720 46.652 .000 .782 Lower bound 1882.720 1.000 1882.720 46.652 .000 .782 Error(Exp Condition) Sphericity Assumed 524.637 13 40.357 Greenhouse Geisser 524.637 13.000 40.357 Huynh Feldt 524.637 13.000 40.357 Lower bound 524.637 13.000 40.357 Phase Sphericity Assumed 3489.702 3 1163.234 101.732 .000 .887 Greenhouse Geis ser 3489.702 2.103 1659.602 101.732 .000 .887 Huynh Feldt 3489.702 2.518 1385.954 101.732 .000 .887 Lower bound 3489.702 1.000 3489.702 101.732 .000 .887 Error(Phase) Sphericity Assumed 445.937 39 11.434 Greenhouse Geisser 445.937 27.336 16.313 Huynh Feldt 445.937 32.733 13.624 Lower bound 445.937 13.000 34.303 ExpCondition*Phase Sphericity Assumed 1130.066 3 376.689 24.692 .000 .655 Greenhouse Geisser 1130.066 1.825 619.046 24.692 .000 .655 Huynh Feldt 1130.066 2.108 536.060 24. 692 .000 .655 Lower bound 1130.066 1.000 1130.066 24.692 .000 .655 Error Sphericity Assumed 594.970 39 15.256 (ExpCondition*Phase) Greenhouse Geisser 594.970 23.731 25.071 Huynh Feldt 594.970 27.405 21.710 Lower bound 594.970 13.000 45.767

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72 Table 4 5 Estimates of Measure: MEASURE 1 Exp Condition Mean Std. Error Lower Bound Upper Bound 1 144.446 2.095 139.919 148.972 2 136.246 1.921 132.096 140.395 Table 4 6 Pairwise Comparisons of Measure: MEASURE 1 (I) Exp Condition (J) Exp Condi tion Mean Difference (I J) Std. Error Sig.* Lower Bound Upper Bound 1 2 8.200* 1.201 .000 5.606 10.794 2 1 8.200* 1.201 .000 10.794 5.606 Based on estimated marginal means *The mean difference is significant at the .05 level. a. Adjustment for multi ple comparisons: Bonferroni. Table 4 7 Estimates of Measure: MEASURE 1 Phase Mean Std. Error Lower Bound Upper Bound 1 134.500 2.114 129.933 139.067 2 135.625 2.055 131.186 140.064 3 148.114 1.949 143.903 152.326 4 143.143 1.858 139.129 147.157 Tab le 4 8 Pairwise Comparisons (I) Phase (J) Phase Mean Difference (I J) Std. Error Sig.* Lower Bound Upper Bound 1 2 1.125 .482 .219 2.624 .374 3 13.614* 1.033 .000 16.823 10.406 4 8.643* 1.021 .000 11.815 5.471 2 1 1.125 .482 .219 .374 2.624 3 12.489* 1.018 .000 15.652 9.327 4 7.518* .887 .000 10.275 4.761 3 1 13.614* 1.033 .000 10.406 16.823 2 12.489* 1.018 .000 9.327 15.652 4 4.971* .858 .000 2.307 7.636 4 1 8.643* 1.021 .000 5.471 11.815 2 7.518* .887 .000 4.761 10.275 3 4.971* .858 .000 7.636 2.307 Based on estimated marginal means a. Adjustment for multiple comparisons: Bonferroni. *The mean difference is significant at the .05 level.

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73 Table 4 9. ExpCondition Phase Measure: Oxygen Saturation Exp Condition Phase Mean Std. Error Lower Bound Upper Bound 1 1 98.400 .577 97.153 99.647 2 97.821 .881 95.919 99.724 3 92.886 1.205 90.283 95.488 4 94.300 1.000 92.139 96.461 2 1 97.907 .691 96.414 99.400 2 98.179 .686 96.697 99.660 3 96.129 .804 94.391 97.866 4 97.686 .644 96.295 99.076 Figure 4 1. Estimated marginal means of measure 1

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74 Table 4 10. Descriptive Statistics of Oxygen Saturation Mean Std. Deviation N OXSATCPhase1 98.4000 2.16013 14 OXSATCPhase2 97.8214 3.29543 14 OXSATCPhase3 92.8857 4.50758 14 OXSATCPhase4 94.300 3.74227 14 OXSATIPhase1 97.9071 2.58560 14 OXSATIPhase2 98.1786 2.56535 14 OXSATIPhase3 96.1286 3.00933 14 OXSATIPhase4 97.6857 2.40859 14 Table 4 11. Mauchlys Test of Sphericity Measure: Oxygen Saturation Within Su bjects Effect Mauchlys W Approx Chi Square Df Sig Greenhouse Geisser Epsilon* HuynhFeldt Lower bound ExpCondition 1.000 .000 0 1.000 1.000 1.000 Phase .191 19.405 5 .002 .530 .592 .333 ExpCondition*Phase .335 12.827 5 .026 .636 .743 .333 Tes ts the null hypothesis that the error covariance matrix of the orthonormalized transformed dependent variables is proportional to an identity matrix. a. May be used to adjust the degrees of freedom for the averaged tests of significance. Corrected tests ar e displayed in the Tests of Within-Subjects Effects table. b. Design: Intercept Within Subjects Design: ExpCondition + Phase + ExpCondition*Phase The Mauchlys test was significant for phase, W = .191, X2 (5) = 19.40, p = .002, and significant for the inte raction effect, W = .335, X2 (5) = 12.8, p = .026.

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75 Table 4 12. Tests of Within-Subjects Effects Measure: O xygen Saturation Source Type III Sum of Squares Df Mean Square F Sig Partial Eta Squared Noncent parameter Observed Power* ExpConditi on Sphericity Assumed 73.775 1 73.775 19.082 .001 .595 19.082 .981 Greenhouse Geisser 73.775 1.000 73.775 19.082 .001 .595 19.082 .981 Huynh Feldt 73.775 1.000 73.775 19.082 .001 .595 19.082 .981 Lower bound 73.775 1.000 73.775 19.082 .001 .595 19.08 2 .981 Error(ExpCondition) Sphericity Assumed 50.262 13 3.866 Greenhouse Geisser 50.262 13.000 3.866 Huynh Feldt 50.262 13.000 3.866 Lower bound 50.262 13.000 3.866 Phase Sphericity Assumed 254.973 3 84.991 53.829 .000 .805 161. 487 1.000 Greenhouse Geisser 254.973 1.591 160.227 53.829 .000 .805 85.659 1.000 Huynh Feldt 254.973 1.777 143.447 53.829 .000 .805 95.679 1.000 Lower bound 254.973 1.000 254.973 53.829 .000 .805 53.829 1.000 Error(Phase) Sphericity Assumed 61.578 3 9 1.579 Greenhouse Geisser 61.578 20.687 2.977 Huynh Feldt 61.578 23.107 2.665 Lower bound 61.578 13.000 4.737 ExpCondition*Phase Sphericity Assumed 82.672 3 27.557 22.282 .000 .632 66.847 1.000 Greenhouse Geisser 82.672 1.909 43.312 22.282 .000 .632 42.531 1.000 Huynh Feldt 82.672 2.229 37.089 22.282 .000 .632 49.667 1.000 Lower bound 82.672 1.000 82.672 22.282 .000 .632 22.282 .992 Error Sphericity Assumed 48.233 39 1.237 (ExpCondition*Phase) Greenhouse Geisser 48.2 33 24.814 1.944 Huynh Feldt 48.233 28.977 1.665 Lower bound 48.233 13.000 3.710 a. Computed using alpha = .05

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76 Table 4 13. Measure: Oxygen Saturation Exp Condition Mean Std. Error 95% Confidence Lower Bound Interval Upper Bo und 1 95.852 .883 93.943 97.760 2 97.475 .679 96.008 98.942 Table 4 14. Pairwise Comparisons Measure: Oxygen Saturation (I) Exp Condition (J) Exp Condition Mean Difference (I J) Std. Error Sig.a Lower Bound Upper Bound 1 2 1.623 .372 .001 2.426 .820 2 1 1.623 .372 .001 .820 2.426 Based on estimated marginal means. *The mean difference is significant at the .05 level. Adjustment for multiple comparisons: Bonferroni. Table 4 15. Estimates Measure: Oxygen Saturation Phase Mean Std. Error Lower B ound Upper Bound 1 98.154 .620 96.815 99.493 2 98.000 .764 96.349 99.651 3 94.507 .969 92.415 96.600 4 95.993 .780 94.309 97.677 Table 4 16. Pairwise Comparisons Measure: Oxygen Saturation (I) Phase (J) Phase Mean Difference (I J) Std. Error Sig. Lower Bound Upper Bound 1 2 .154 .217 1.000 5.222 .829 3 3.646* .502 .000 2.088 5.205 4 2.161* .276 .000 1.302 3.019 2 1 .154 .217 1.000 .829 .522 3 3.493* .354 .000 2.393 4.593 4 2.007* .242 .000 1.255 2.759 3 1 3.646* .502 .000 5.205 2.088 2 3.493* .354 .000 4.593 2.393 4 1.486* .343 .005 2.551 .421 4 1 2.161* .276 .000 3.019 1.302 2 2.007* .242 .000 2.759 1.255 3 1.486* .343 .005 .421 2.551 Based on estimated marginal means a. Adjustment for multiple comparisons: Bonferroni. *The mean difference is significant at the .05 level.

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77 Table 4 17. ExpCondition Phase Measure: Oxygen Saturation Exp Condition Phase Mean Std. Error Lower Bound Upper Bound 1 1 98.400 .577 97.153 99.647 2 97.821 .881 95.919 99.724 3 9 2.886 1.205 90.283 95.488 4 94.300 1.000 92.139 96.461 2 1 97.907 .691 96.414 99.400 2 98.179 .686 96.697 99.660 3 96.129 .804 94.391 97.866 4 97.686 .644 96.295 99.076 Figure 4 2. Estimated marginal means of oxygen saturation Table 4 18. D escriptive Statistics of NIPS Scores Mean Std. Deviation N NIPSCPre .0204 .07636 14 NIPSCPost 5.0857 .85831 14 NIPSIPre .0000 .00000 14 NIPSIPost 4.6286 .92439 14

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78 Table 4 19. Mauchlys Test of Sphericity Within Subjects Effect Mauchlys W Approx Chi Square Df Sig Greenhouse Geisser Epsilon* HuynhFeldt Lower bound ExpCondition 1.000 .000 0 1.000 1.000 1.000 Phase 1.000 .000 0 1.000 1.000 1.000 ExpCondition*Phase 1.000 .000 0 1.000 1.000 1.000 Tests the null hypothesis that the error covariance matrix of the orthonormalized transformed dependent variables is proportional to an identity matrix. a. May be used to adjust the degrees of freedom for the averaged tests of significance. Corrected tests are displayed in the Tests of Within-Sub jects Effects table. b. Design:Intercept Within Subjects Design: ExpCondition+Phase+ExpCondition*Phase The test was not significant for condition, phase, or interaction effect.

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79 Table 4 20. Tests of Within-Subjects Effects Measure: NIPS Score Source Type III Sum of Squares Df Mean Square F Sig Partial Eta Squared Noncent parameter Observed Power* ExpCondition Sphericity Assumed .798 1 .798 2.468 .140 .160 2.468 .307 Greenhouse Geisser .798 1.000 .798 2.468 .140 .160 2.468 .307 Huynh Fel dt .798 1.000 .798 2.468 .140 .160 2.468 .307 Lower bound .798 1.000 .798 2.468 .140 .160 2.468 .307 Error(ExpCondition) Sphericity Assumed 4.205 13 .323 Greenhouse Geisser 4.205 13.000 .323 Huynh Feldt 4.205 13.000 .323 Lower bound 4.205 13.000 .323 Phase Sphericity Assumed 328.899 1 328.899 697.878 .000 .982 697.878 1.000 Greenhouse Geisser 328.899 1.000 328.899 697.878 .000 .982 697.878 1.000 Huynh Feldt 328.899 1.000 328.899 697.878 .000 .982 697.878 1.000 Lower bound 328.899 1.000 328.899 697.878 .000 .982 697.878 1.000 Error(Phase) Sphericity Assumed 6.127 13 .471 Greenhouse Geisser 6.127 13.000 .471 Huynh Feldt 6.127 13.000 .471 Lower bound 6.127 13.000 .471 ExpCondition*Phase Sphericity Assumed .668 1 .668 1.950 .186 .130 1.950 .253 Greenhouse Geisser .668 1.000 .668 1.950 .186 .130 1.950 .253 Huynh Feldt .668 1.000 .668 1.950 .186 .130 1.950 .253 Lower bound .668 1.000 .668 1.950 .186 .130 1.950 .253 Error Sphericity Assumed 4.450 13 .342 (ExpCondition*Phase) Greenhouse Geisser 4.450 13.000 .342 Huynh Feldt 4.450 13.000 .342 Lower bound 4.450 13.000 .342 a. Computed using alpha = .05

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80 110 120 130 140 150 160 170 180 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 80 85 90 95 100 Oxygen saturation NNS Oxygen saturation nonNNS Heart rate NNS Heart rate nonNNS Heart rate Oxygen saturation Observation Baseline NNS or Continued Baseline Post Heel Stick Heel Stick Figure 4 3 Heart rate and oxygen saturation levels for Infant 1 (Af rican -American male, Gestational Age = 41 days; 6 days old).

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81 110 120130 140 150 160 170 180 1 23 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 2223 24 50 5560 65 70 75 80 85 90 95 100 Oxygen saturation NNS Oxygen saturation nonNNS Heart rate NNS Heart rate nonNNS Heart rate Oxygen saturation Observation Baseline NNS or Continued Baseline Post Heel Stick Heel Stick Fi gure 4 4 Heart rate and oxygen saturation levels for Infant 2 ( Hispanic female, Gestational Age = 37 days, 13 days old).

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82 110 120130 140 150 160 170 180 1 23 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 2223 24 50 5560 65 70 75 80 85 90 95 100 Oxygen saturation NNS Oxygen saturation nonNNS Heart rate NNS Heart rate nonNNS Heart rate Oxygen saturation Observation Baseline NNS or Continued Baseline Post Heel Stick Heel Stick Figure 4 5 Heart rate and oxygen saturation levels for Infant 3 (C aucasian female, Gestational Age = 36 days; 9 days old)

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83 110 120 130 140 150 160 170 180 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 50 55 60 65 70 75 80 85 90 95 100 Oxygen saturation NNS Oxygen saturation nonNNS Heart rate NNS Heart rate nonNNS Heart rate Oxygen saturation Observation Baseline NNS or Continued Baseline Post Heel Stick Heel Stick Figure 4 6 Heart rate and oxygen saturation levels for Infant 4 (African-American male, Gestational Age = 32 days; 1 day old).

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84 110 120 130 140 150 160 170 180 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 1617 18 19 20 21 22 23 24 50 55 60 65 70 75 80 85 90 95 100 Oxygen saturation NNS Oxygen saturation nonNNS Heart rate NNS Heart rate nonNNS Heart rate Oxygen saturation Observation Baseline NNS or Continued Baseline Post Heel Stick Heel Stick Figure 4 7 Heart rate and oxygen saturation levels for Infant 5 (Af rican -American male, Gestational Age = 34 days; 19 days old).

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85 110 120 130 140 150 160 170 180 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 50 55 60 65 70 75 80 85 90 95 100 Oxygen saturation NNS Oxygen saturation nonNNS Heart rate NNS Heart rate nonNNS Heart rate Oxygen saturation Observation Baseline NNS orContinued Baseline Post Heel Stick Heel Stick Figure 4 8 Heart rate and oxygen saturation levels for Infant 6 (African-American male, Gestational Age 38 days; <1 day old).

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86 110 120 130 140 150 160 170 180 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 50 55 60 65 70 75 80 85 90 95 100 Oxygen saturation NNS Oxygen saturation nonNNS Heart rate NNS Heart rate nonNNS Heart rate Oxygen saturation Observation Baseline NNS or Continued Baseline Post Heel Stick Heel Stick Figure 4 9 Heart rate and oxygen saturation levels for Infant 7 ( Hispanic female, Gestational Age = 38 days; 2 days old).

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87 110 120 130 140 150 160 170 180 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 50 55 60 65 70 75 80 85 90 95 100 Oxygen saturation NNS Oxygen saturation nonNNS Heart rate NNS Heart rate nonNNS Heart rate Oxygen saturation Observation Baseline NNS or Continued Baseline Post Heel Stick Heel Stick Figure 4 10. Heart rate and oxygen saturation levels for Infant 8 (Caucasian male, Gestational Age = 34 days; 1 day old).

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88 110 120 130 140 150 160 170 180 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 50 55 60 65 70 75 80 85 90 95 100 Oxygen saturation NNS Oxygen saturation nonNNS Heart rate NNS Heart rate nonNNS Heart rate Oxygen saturation Observation Baseline NNS or Continued Baseline Post Heel Stick Heel Stick Figure 4 11. Heart rate and oxygen saturation levels for Infant 9 (Hispanic male, Gestational Age = 37 days, 1 day old).

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89 110 120 130 140 150 160 170 180 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 50 55 60 65 70 75 80 85 90 95 100 Oxygen saturation NNS Oxygen saturation nonNNS Heart rate NNS Heart rate nonNNS Heart rate Oxygen saturation Observation Baseline NNS or Continued Baseline Post Heel Stick Heel Stick Figure 4 1 2 Heart rate and oxygen saturation levels for Infant 10 (Asian male, Gestational Age = 32 days; 1 day old )

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90 110 120 130 140 150 160 170 180 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 1617 18 19 20 21 22 23 24 50 55 60 65 70 75 80 85 90 95 100 Oxygen saturation NNS Oxygen saturation nonNNS Heart rate NNS Heart rate nonNNS Heart rate Oxygen saturation Observation Baseline NNS or Continued Baseline Post Heel Stick Heel Stick Figure 4 1 3 Heart rate and oxygen saturation levels for Infant 11 (Caucasian f emale, Gestational Age = 33 days; 5 days old).

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91 110 120 130 140 150 160 170 180 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 50 55 60 65 70 75 80 85 90 95 100 Oxygen saturation NNS Oxygen saturation nonNNS Heart rate NNS Heart rate nonNNS Heart rate Oxygen saturation Observation Baseline NNS or Continued Baseline Post Heel Stick Heel Stick Figure 4 1 4 Heart rate and oxygen saturation levels for Infant 12 ( Hispanic male, Gestational Age = 32 days; 5 days old).

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92 110 120 130 140 150 160 170 180 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 50 55 60 65 70 75 80 85 90 95 100 Oxygen saturation NNS Oxygen saturation nonNNS Heart rate NNS Heart rate nonNNS Heart rate Oxygen saturation Observation Baseline NNS or Continued Baseline Post Heel Stick Heel Stick Figure 4 1 5 Heart rate and oxygen saturation levels for Infant 13 (African-Ameri can female, Gestational Age = 32 days; 1 day old).

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93 110 120 130 140 150 160 170 180 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 50 55 60 65 70 75 80 85 90 95 100 Oxygen saturation NNS Oxygen saturation nonNNS Heart rate NNS Heart rate nonNNS Heart rate Oxygen saturation Observation Baseline NNS or Continued Baseline Post Heel Stick Heel Stick Figure 4 1 6 Heart rate and oxygen saturation levels for Infant 14 (Caucasian male, Gestational Age = 36 days; 3 days old).

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94 Figure 4 1 7 Mean heart rate across control and NNS conditions. 120 125 130 135 140 145 150 155 160 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Observation Mean Heart Rate Control NNS Baseline NNS or Baseline (cont d) Post Heel Stick

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95 88 90 92 94 96 98 100 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 Observation Mean Oxygen Saturation (%) Control NNS Baseline NNS or Baseline (cont d) Post Heel Stick Figure 4 1 8 Mean oxygen saturation levels across control and NNS conditions.

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96 0 1 2 3 4 5 6 7 1 2 3 4 5 6 7 8 9 10 11 12 Control NNS Baseline Post Heel StickObservationMean NIPS Rating Figure 4 1 9 Mean NIP ratings across control and NNS conditions.

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97 Table 4 21. Characteristics of Race Frequency Percent Valid Percent Cumulative Percent Valid Caucasian 4 28.6 28.6 28.6 Black 5 35.7 35.7 64.3 Hispanic 4 28.6 28.6 92.9 Asian 1 7.1 7.1 100.0 Total 14 100.0 100.0 Table 4 22. Characteristics of Gender Frequency Percent Valid Percent Cumulative Percent Valid M ale 9 64.3 64.3 64.3 F emale 5 35.7 35.7 100.0 Total 14 100.0 100.0 Table 4 23. Characteristics of APGAR Scores at 1 minute Frequency Percent Valid Percent Cumulative Percent Valid 1 2 14.3 14.3 14.3 3 2 14.3 14.3 28.6 4 1 7.1 7.1 35.7 6 2 14.3 14.3 50.0 7 2 14.3 14.3 64.3 8 5 35.7 35.7 100.0 Total 14 100.0 100.0 Table 4 24. Characteristics of APGAR Scores at 5 minutes Frequency Percent Valid Percent Cumulative Percent Valid 4 2 14.3 14.3 14.3 6 2 14.3 14.3 28.6 7 1 7.1 7.1 35.7 8 5 35.7 35.7 71.4 9 4 28.6 28.6 100.0 Total 14 100.0 100.0

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98 Table 4 25. Characteristics of C Section Frequencies Frequency Percent Valid Percent Cumulative Percent Valid Y es 13 92.9 92.9 92.9 N o 1 7.1 7.1 100.0 Total 14 100.0 100.0 Table 4 26. Demograp hics of Birth Weight, APGAR Scores, and Ventilator Settings Birth weight GM APGAR 1 min APGAR 5 min Fi02 IMV PEEP N Valid 14 14 14 14 14 14 Missing 0 0 0 0 0 0 Mean 2351.86 5.57 7.36 27.14 23.79 4.64 Median 2280.50 6.50 8.00 26.50 25.00 5.00 Std Deviation 805.353 2.652 1.737 5.362 6.179 .842 Minimum 1 769 1 4 21 8 3 Maximum 3642 8 9 38 30 6 Table 4 27. Characteristics of Individual Birth Weights Frequency Percent Valid Percent Cumulative Percent Valid 1 769 1 7.1 7.1 7.1 1359 1 7.1 7.1 14.3 1604 1 7.1 7.1 21.4 1814 1 7.1 7.1 28.6 2166 1 7.1 7.1 35.7 2240 1 7.1 7.1 42.9 2275 1 7.1 7.1 50.0 2286 1 7.1 7.1 57.1 2535 1 7.1 7.1 64.3 2612 1 7.1 7.1 71.4 3030 1 7.1 7.1 78.6 3191 1 7.1 7.1 85.7 3403 1 7.1 7.1 92.9 3642 1 7.1 7.1 100.0 Total 14 100.0 100.0

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99 Table 4 28. Characteristics of FiO2 Frequencies Frequency Percent Valid Percent Cumulative Percent Valid 21 3 21.4 21.4 21.4 23 1 7.1 7.1 28.6 24 2 14.3 14.3 42.9 25 1 7.1 7.1 50.0 28 1 7.1 7.1 57.1 29 2 14.3 14.3 71.4 30 1 7.1 7.1 78.6 32 1 7.1 7.1 85.7 35 1 7.1 7.1 92.9 38 1 7.1 7.1 100.0 Total 14 100.0 100.0 Table 4 29. Characteristics of IMV Frequencies Frequency Percent Valid Percent Cumulative Percent Valid 8 1 7.1 7.1 7.1 18 1 7.1 7.1 14.3 20 2 14.3 14.3 28.6 21 1 7.1 7.1 35.7 23 1 7.1 7.1 42.9 25 3 21.4 21.4 64.3 28 1 7.1 7.1 71.4 30 4 28.6 28.6 100.0 Total 14 100.0 100.0 Table 4 30. Characteristics of PEEP Frequencies Frequency Percent Valid Percent Cumulative Percent Valid 3 1 7.1 7.1 7.1 4 5 35.7 35.7 42.9 5 6 42.9 42.9 85.7 6 2 14.3 14.3 100.0 Total 14 100.0 100.0

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100 Table 4 31. Mean Phase Differences in Infant Heart Rate and Oxygen Saturation in Experimental and Control Conditions Hear t Rate Oxygen Saturation Phase Non NNS (SD) NNS (SD) Non NNS (SD) NNS (SD) Baseline (Phase1) 135.12 (9.29) 133.88 (7.65) 98.40 (2.16) 97.91 (2.59) NNS/Baseline 2 (Phase 2) 136.88 (10.12) 134.38 (6.59) 97.82 (3.30) 98.18 (2.57) Immediate Reactio n (Phase 3) 155.14 (7.56) 141.09 (8.28) 92.89 (4.51) 96.13 (3.01) Recovery (Phase 4) 150.64 (7.53) 135.64 (7.71) 94.30 (3.74) 97.69 (2.41) Note Baseline: first ten resting measurements; NNS/Baseline 2: Next four measurements (NNS was introduc ed in treatment condition, baseline was extended in non -NNS condition); Immediate Reaction: first five measurements post -heel stick; Recovery: last five measurements post heel stick.

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101 Table 4 32. Infant H eart Rate R ecovery Recovery (HR Post Heel Stick) Infant Condition M SD 95% CI Upper Limit 95%CI Lowest HR HRCI OBS z 1 Non NNS 121.71 3.31 123.77 140 N/A DNR 5.52 NNS 121.29 4.66 124.18 122 122 5 .15 5.36 2 Non NNS 134.43 2.62 136.05 148 N/A DNR 5.17 NNS 137.07 2.62 138.69 130 132 5 2.70 7.88 3 Non NNS 124.14 2.66 125.79 138 N/A DNR 5.22 NNS 126.43 2.21 127.80 130 130 DNR 1.62 3.60 4 Non NNS 153.21 2.89 155.00 160 N/A DNR 2.35 NNS 144.07 2.34 145.52 152 152 DNR 3.39 1.04 5 Non NNS 133.14 2.68 134.81 140 N/A DNR 2.55 NNS 135.43 2.87 137.21 128 136 6 2.58 5.14 6 Non NNS 140.57 2.28 141.98 150 N/A DNR 4.14 NNS 142.21 3.60 144.44 140 144 3 0.62 4.76 7 Non NNS 129.86 2.66 131.50 156 N/A DNR 9.84 NNS 132.43 2.62 134.05 132 132 5 0.16 10.01 8 Non NNS 137.57 1.91 138.76 144 N/A DNR 3.37 NNS 141.86 3.08 143.77 138 140 1 1.25 4.62 9 Non NNS 130.00 3.68 132.28 140 N/A DNR 2.72 NNS 121.36 2.34 122.81 124 124 DNR 1.13 1.59 10 Non NNS 134.86 1.29 135.66 146 N/A DNR 8.62 NNS 135.21 2.22 136.59 136 136 7 0.35 8.27

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102 Table 4 32. Continued Recovery (HR Post Heel Stick) Infant Condition M SD 95% CI Upper Limit 95%CI Lowest HR HRCI OBS z 11 Non NNS 127.64 1.22 128.40 137 N/A DNR 7.70 NNS 132.86 1.29 133.66 132 132 7 0.66 8.36 12 Non NNS 145.64 2.10 146.94 154 N/A DNR 3.98 NNS 140.57 2.41 142.06 142 142 DNR 0.59 3.39 13 Non NNS 152.00 3.33 154.06 160 N/A DNR 2.40 NNS 1 34.57 1.95 135.78 134 134 9 0.29 2.70 14 Non NNS 133.93 2.79 135.66 146 N/A DNR 4.33 NNS 130.93 2.79 132.66 132 132 6 0.38 3.95 Note. M = Mean heart rate (HR) for fourteen observation sessions prior to heel stick; OBS = Number of observations p ost -heel stick until heart rate was inside upper limit of 95% confidence interval; HRCI = value of first occurrence of infant recovery heart rate within 95% confidence interval for baseline mean; LOWEST HR = Lowest recorded heart rate during ten post -heel stick recovery observations. DNR = Heart rate did not recover to a value within 95% confidence interval of baseline heart rate during ten post heel stick observations (scheduled 30 seconds apart). z = z -score for lowest heart rate post -heel stick referenc ed against baseline mean and z -score for lowest heart rate post -heel stick from control condition to NNS condition. Change is measured in standard deviation units. Negative sign indicates change in therapeutic direction.

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103 Table 4 33. Infant Oxygen S aturation R ecovery Recovery (HR Post Heel Stick) Infant Condition M SD 95% CI Lower Limit Highest OX OXCI OBS z 1 Non NNS 98.90 0.74 98.44 98 N/A DNR 1.22 NNS 99.60 0.52 99.28 99 N/A DNR 1.16 0 .06 2 Non NNS 98.50 0.53 98.17 96 N/A DNR 4.74 NNS 98.60 0.52 98.28 99 99 7 0.77 5.52 3 Non NNS 99.60 0.52 99.28 97 N/A DNR 5.03 NNS 99.70 0.48 99.40 99 N/A DNR 1.45 3.59 4 Non NNS 100.00 0.00 100.00 98 N/A DNR N/A NNS 99.10 0.57 98.75 98 N/A DNR 1.94 N/A 5 Non NNS 92.20 2.39 90.72 86 N/A DNR 2.59 NNS 90.40 2.07 89.12 90 92 5 0.77 3.36 6 Non NNS 99.50 0.53 99.17 96 N/A DNR 6.64 NNS 98.60 0.52 98.28 99 100 3 2.71 9.35 7 Non NNS 99.40 0.52 99.08 95 N/A DNR 2.71 NNS 95 .80 0.63 95.41 98 96 4 3.48 6.19 8 Non NNS 99.80 0.42 99.54 94 N/A DNR 1.90 NNS 99.50 0.53 99.17 100 100 8 0.95 2.85 9 Non NNS 98.60 0.52 98.28 94 N/A DNR 8.91 NNS 98.70 0.48 98.40 99 100 4 2.69 11.60 10 Non NNS 97.50 0.53 97.17 94 N/A DN R 664 NNS 97.70 0.48 97.40 98 99 3 2.69 9.33

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104 Table 4 33. Continued Recovery (HR Post Heel Stick) Infant Condition M SD 95% CI Lower Limit Highest OX OXCI OBS z 11 Non NNS 9550 0.85 94.97 94 N/A DNR 1.77 NNS 95.10 0.74 94.64 95 96 3 1.22 2.98 12 Non NNS 99.80 0.42 99.54 98 N/A DNR 4.27 NNS 99.70 0.48 99.40 99 N/A DNR 1.45 2.82 13 Non NNS 98.30 0.48 98.00 94 N/A DNR 8.90 NNS 98.60 0.52 98.28 98 N/A DNR 1.16 7.74 14 Non NNS 100.00 0.00 100.00 99 N/A DNR N/A NNS 99.60 0.52 99.28 100 100 8 0.77 N/A Note. M = Mean oxygen saturation level for fourteen observation sessions prior to heel stick; OBS = number of observations post heel stick until oxygen saturation value was inside lower limit of 95% confidence interval; OXCI = oxygen saturation level when first within lower limit of 95% confidence interval; HIGHEST OX = Highest oxygen saturation level during ten post heel stick recovery observations. DNR = Oxygen saturation level did not recover to a value within upper limit of 95% confidence interval of baseline; z = z change in z score for highe st oxygen saturation level post heel stick from control condition to NNS condition. Change is measured in standard deviation units. Positive value indicates change in therapeutic direction.

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105 CHAPTER 5 DISCUSSION Summary The purpose of this study was t o determine the effect of nonnutritive sucking (NNS) combined with sucrose -induced analgesia on heart rate, oxygen saturation, and pain behaviors (measured by the Neonatal Infant Pain Scale) in intubated infants between the ages of 32 weeks gestation to le ss than or equal to 42 weeks gestation. In order to determine the effect of NNS combined with sucrose -induced analgesia (treatment condition) on the dependent variables (heart rate, oxygen saturation, and pain behaviors), three specific aims were identifi ed. The first s pecific a im one was to d etermine the effect of NNS and sucrose induced analgesia (treatment condition) on heart rate in intubated infants during a painful event (heel stick). It was determined as hypothesized that infants had lower mean h eart rates in the NNS condition with sucrose (treatment condition) during a heel stick than those infants not offered NNS with sucrose (control condition). The second specific aim was to d etermine the effect of NNS and sucrose induced analgesia (treatment condition) on oxygen saturation in intubated infants during a painful event (heel stick). It was determined as hypothesized that infants had higher mean oxygen saturations in the NNS condition with sucrose (treatment condition) as measured by noninvasive pulse oximetry during a heel stick than those infants not offered NNS with sucrose (control condition). The third specific aim was to d etermine the NIPS scores in the NNS condition with sucrose (treatment condition) in intubated infants during a painful e vent (heel stick). It was determined as hypothesized that i nfants had lower NIPS scores in the NNS condition with sucrose (treatment condition) during a heel stick than those infants not offered NNS with sucrose (control condition ).

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106 In the treatment condition the in f ant s w ere offered NNS with sucrose and in the control condition w ere not H eart rate and oxygen saturation w ere me asured in 30-second intervals during a 5 -minute baseline period, a heel stick, and a 5 -minute follow up period. P ain behaviors w ere m easured in one minute intervals. In this study all heel sticks elicited a response even though different RNs performed the heel stick. All dependent variables returned to baseline during or after the 5 -minute follow up period. However, the rate at which the variables stabilized was greater in the treatment condition as compared to the control. A visible depiction of the return to baseline of mean heart rates, oxygen saturations, and NIPS ratings in the control and treatment condition is illustrate d in Figure 4 15, 4 16, ad 417. An explanation suggested for the faster rate of return to baseline is the treatment of NNS with sucrose induced analgesia. Comparable studies of infants not receiving oral or nasogastric nutrition, and examining ventilator data is unique in concept and study completion For example, previous s tudies have been conducted with infants examining nonnutritive sucking ( with or without sucrose ) describing stability or the pain response (Gibbens, et al., 2002; Pinelli, Symington, & Ciliska (2002). M any of those studies involve infants with NNS before or while tube/bottle feeding (DiPietro, 1994; Gill, 1992, McCain, 1995). However, those infants were not intubated and on mechanical ventilation Stevens and Ohlsson (2004) studied sucrose administered by oral syringe, nasogastric tube, or pacifier for analgesia in newborn infants undergoing heel sticks or ven e punctures. Whether or not the infants were intubated on mechanical ventilation is unclear. Not all infants, either term or preterm, in the neonatal intensive care unit are intubated and on mechanical ventilation. Other studies (Gibbins, et. al., 2002; Stevens, et al., 2005) examined the effect of sucrose for

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107 procedural pain in preterm and term infants. Although those studie s did not exclude intubated infants as admission criteria, the ventilator settings (such as intermittent mechanical ventilation, continuous positive airway pressure, percentage of oxygenation) were not disclosed or even discussed. In this study the mean FiO2 was 27.14 (SD 5.3); mean IMV was 23.79 (SD = 6.18) ; mean PEEP was 4.64 (SD = 0.84). The demographics of ventilator settings in this study are depicted in Table 4 6. The characteristics of FiO2, IMV, and PEEP frequencies are depicted in Tables 4 8, 4 9, and 4 10. Clearly the standard of care is for all infants to exist in a minimal pain, or pain free environment. Unfortunately, that has not been consistently achieved. There is no reason to think infants would not suffer from repeated painful proce dures. This study clearly demonstrated that physiologic and behavioral changes occurred following a routine event. Issues and Limitations Despite the large census of the neonatal intensive care unit where the study was conducted (a daily census of greate r than one hundred per day), infants who met the criteria were far fewer A similar study examining physiologic and behavioral changes following a routine painful event with NNS sucrose induced analgesia in the intubated neonatal population had not been done before at this facility or reported in the literature. There are several issues that need to be considered as mediating effects. These include gestational age and age in days, weight, infant acuity, and parental availability. The i nfants in this st udy not only had to be sick enough to require intubation and mech an ical ventilation, but also functional enough to respond to stimuli and able to suck. Sucking behavior has been documented prior to birth as early as 18 weeks gestation (Wirson, 1965). Consistent sucking has been documented by 32 weeks gestation (Medoff Cooper, Verklan, & Carlson, 1993).

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108 Gestational age and age in days could therefore alter the results of the study if the infant was too young. All infants in this study were at least 32 w eeks gestational age. The mean gestational age was 35.14 ( SD = 2.85) with a mean age in days of 4.79 (SD = 5.58; Range: 19). The demographics of gestational age and age in days at point of study are depicted in Table 3 1. Another issue in regard to age i s accumulated exposure to painful stimuli. The longer the infant remains hospitalized particularly in the intensive care unit, theoretically the more painful events would be experience d Frequen cy of painful exposures may alter the results, and thus pre sent an issue. To avoid this in the study, a 30 minute uneventful period for the infant was required prior to the heel stick. In addition to age, birth weight was a factor that mediated effect Characteristics of individual birth weights are listed in Table 4 7. The mean birth weight in grams was 2351.86 (SD = 805.35). Demographics for birth weight are listed in Table 4 6. As noted earlier, there was a relatively strong correlation between birth weight (in grams) and the size of the change effect re ported for both heart rate and oxygen saturation (see Tables 4 12 and 4 13). For heart rate, the value of delta is the z -score difference for lowest achieved heart rate in an infant across NNS and non -NNS conditions. Thus, a large negative delta value in dicated a large standardized difference in heart rate recovery in the therapeutic direction. The higher birth weights were associated with greater therapeutic effect (i.e., lower heart rates relative to baseline in the NNS condition). Infant number 7 was the heaviest in the study (3642 grams) and had the largest negative delta value ( 10.01). Birth weight correlated r (12) = 0.62, p = 0.17 with the delta value for heart rate recovery, meaning that higher birth weights were associated with greater therapeu tic effect (i.e., lower heart rates relative to baseline in the NNS condition) but was not

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109 statistically significant. The effect was not as large for oxygen saturation and the result was not statistically significant, r (12) = .27, ns In addition to a ge, weight, and infant acuity, parental availability was also an issue. Many parents were not available for obtainment of consent and therefore the infants could not be included in the study Reasons for lack of parent availability included the recoveri ng physical condition of the mother limiting her ability to consent. For example, a limitation was if the mother had just undergone a cesarean section and was not able to cognitively consent. The lack of pa rental presence was primarily the lack of the fa thers presence. The lack of parental availability was a limitation. It is feasible that some subjects could have been missed. Despite an almost daily review of existing potential subjects by the researcher, the time period for data collection of the 14 subjects was almost six months. A limitation of this study was the r outine and medically required heel sticks needed for measurement of the painful event. Heel sticks are often routine, but not necessarily frequent. With the possibility of arterial or u mbilical lines in the intensive care unit, the frequency of drawing blood needed for laboratory measurement (such as for glucose values) from heel sticks was reduced or eliminated The design of this study required the infant s to serve as their own contro l and thus required 2 separate heel sticks (one for the treatment and one for the control condition). If the infant did not require a heel stick for blood collection, or another method was chosen (such as by venipuncture, arterial stick, or umbilical li ne stick), the heel stick was not performed. Another limitation of this study was during data collection the second observer collected data on the NIPS scores only and not heart rate or oxygen saturation. The primary researcher collected data on the NIPS scores, heart rate, and oxygen saturation. As a result there was no

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110 inter rater reliability for heart rate and o xygen saturation, only the NIPS scores. This could have affected the findings. During the data collection process n o videotaping of the subj ects was allowed in the neonatal intensive care unit due to the increased lighting and noise. C ontinuous hard copy tracings of the heart rate and oxygen saturation w ere also not a vailable Videotaping and hard copy tracings are both measures that could h ave provided visual documentation. Lack of both presented a limitation to the study and were not anticipated during the planning Application P ainful procedures continue to exist in the hospital setting Pain assessment is essential for nursing practice, but the measurement of pain in the nonverbal population remains difficult. The nonverbal intubated infant is not able to verbally state the presence of pain, and physiologic indicators such as vital signs are often unreliable. The participation of nurses in pain management is crucial to achieve positive health outcomes for infants who are positioned to experience repetitive or severe pain. Nurse researchers have a duty to find nursing interventions that will work and to validate their use at the bedside especially for patients who cannot advocate for themselves (American Academy of Pediatrics, 2000). Nurses are best positioned to assess, treat, and prevent pain in the hospital ized patient because they are nearest the patient. One frequently studied inter vention nurses can employ to alleviate infant pain is nonnutritive sucking (NNS). Attention to comfort is a foundational element of nursing (Watson, 1979). Ethically, there is an obligation for nurses to look for an expression of pain and to alleviate pai n in those who cannot advocate for themselves (Beauchamp & Childress, 2008) This applies to an intubated newborn who cannot verbalize pain through a cry. This also applies to those unable to communicate pain regardless of age, such as those with dementi a or altered mental status This

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111 disparity in treatment between those who are able to verbalize pain (those not intubated or with verbal cognition) and those who are not continues today (Gibbins et al., 2002). Ethical principles can serve as guides in the treatment of pain Two bioethical considerations, nonmaleficence and beneficence, and the concept of caring, were used to guide this research. Conflicts regarding the need to perform necessary procedures that cause harmful pain and the medical benefits co ntinue. Given that infants are persons and entitled to moral regard, an understanding of the moral principles that guide medical care is important in this vulnerable population. Ethical principles can serve as guides in the treatment of pain Thi s stud y d emonstrate d respect for the principles of nonmaleficence beneficence and caring with infants who were not able to seek relief. R ecommendations To increase generalizability to the neonatal population a recommendation for future studies would be to c onsid er examining infants with similar descriptive conditions such as APGAR scores and mode of delivery. The APGAR score was developed in 1952 by anesthesiologist Virginia Apgar and measures 5 factors ( A ctivity, P ulse, G rimace, A ppearance R espiration) at 1 an d 5 minutes post delivery. Each factor is scored on a scale of 0 to 2, with 2 being the best. The factors are added together for a score of 0 to 10, with 10 being the best possible (Apgar, 1952). In this study 8 was the most frequent APGAR score at 1 minute (35.7%) and 5 minutes (35.7%). See Tables 4 3 and 4 4. A nother study could examine infants who were products of the same type of delivery. In this study infants were born mostly by c -sections rather than vaginal deliveries. The frequency of c -s ections (92.9%) was great in this study as compared to vaginal births (7.1%). See Table 4 5. Besides types of delivery, events that occurred during delivery could be examined. For

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112 example, for future study i nfants who were products of epidurals receivin g narcotics or other anesthetic agents could be examined. A r ecommend ation for a future study would be obtainment of continuous hard copy printouts of the heart rate and oxygen saturations. Also, data collection by videotaping the subjects would increas e inter rater reliability for the NIPS scores and documentation of the behaviors Another recommendation would be for longer observation periods beyond the five -minute post heel stick period. Lo ngitudinal data would be helpful in determining when complet e and sustained return to baseline occurred. Although data w ere collected in this study for five minutes post heel stick, complete and sustained return to baseline had not occurred for every subject. Many studies observed behavior for a five -minute perio d (Gill, 1992; DiPietro, 1994). McCain in 1995 observed behavior of the experimental group with NNS for ten minutes. Other studies reviewed lacked long term outcomes (Pinelli, 2003) Longterm outcomes such as oral aversion, or the effect of NNS on brea stfeeding could be explored. In addition none of the s ubjects were followed after discharge from the hospital to measure outcomes (Pinelli, 2003). Additional research to examine and moderate physiologic and pain responses in the intubated infant is needed. Intubated infants are already physiologically compromised needing ventilator assistance either in the form of increased amounts of oxygen, mechanical breathes, or airway pressure. Specific interventions, such as NNS with sucrose described in thi s study, need to be further explored to decrease the stress and pain associated with routine procedures in the neonatal population. Other interventions include altering the environmental surroundings of light, sound, temperature, and touch. While conducti ng this study a notable difference in

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113 behavior occurred when the infants were in the treatment condition of nonnutritive sucking and sucrose induced analgesia in comparison to the control. In addition, d evelopmental outcomes related to procedural pain and stress need to be further explored. Completion of infantile milestones, such as recognition of familiar sound, could be assessed. The quality of the response to pain could be gauged related to stress intensity. In previous studies nonnutritive suckingi nduced analgesia with sucrose has been shown to decrease physiologic and behavioral pain responses. Yet, in practice it is offered less to intubated infants. This is possibly due to a lack of knowledge, experience or workload. Also, the addition of the pacifier with the endotracheal tube is unfamiliar I ncreased education of nurses regarding neonatal pain assessment, intervention, and response is needed. In summary, intubated critically ill infants are unable to vocalize a pain response in the form of a cry due to the blocking of the vocal chords by the endotracheal tube. Pain assessment in this neonatal population is thereby difficult due to the inability of the infants to self report their pain with silent cries of distress. This study included the physiologic measures of heart rate and oxygen saturation, plus pain behaviors as measured by the Neonatal Infant Pain Scale. This study found that the infants had lower mean heart rates higher mean oxygen saturations, and lower NIPS scores in the NNS co ndition with sucrose (treatment condition) during a heel stick than those infants not offered NNS with sucrose (control condition). There was a statistically significant interaction effect in the hypothesized direction for hear rate and oxygen saturation, and latency to recovery times were shorter While pain continues to be a common part of the hospital experience, in this study nonnutritive suckinginduced analgesia with sucrose was effective in positively altering heart rate, oxygen saturation, and pai n behavior.

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114 APPENDIX A NEONATAL INFANT PAIN SCALE (NIPS) NNS and Sucrose-Induced Analgesia Study Date Diagnosis Race Sex GA Age in Heart O2 NIPS Comments STAMP Days Rate Sats % 1 min 2 min Notes 3 min 4 min 5 min NNS 1 min 2 min STICK 1 min 2 min 3 min 4 min Legend 5 min Race Sex a=Caucasia M=male b=Black F=female c=Latin d=Indian e=Asian f=other

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115 Table A 1 Neonatal Infant Pain Scale Pain Assessment Score FACIAL EXPRESSION 0 Relaxed muscles Restful face, neutral expression 1 Grimace Tight facial muscles; fur rowed brow, chin, jaw, (negative facial expression nose, mou CRY 0 No Cry Quiet, not crying 1 Whimper Mild moaning, intermittent 2 Vigorous Cry Loud scream; rising, shrill, continuous (Note: Silent cry may be scored if ba by is intubated as evidenced by obvious mouth and facial movement. BREATHING PATTERNS 0 Relaxed Usual pattern for this infant 1 Change in Breathing Indrawing, irregular, faster than usual; gagging; breath holding ARMS 0 Relaxed/Res trained No muscular rigidity; occasional random movements of arms 1 Flexed/Extended Tense, straight arms; rigid and/or rapid extension, flexion LEGS 0 Relaxed/Restrained No muscular rigidity; occasional random leg movement 1 Flexed/Exte nded Tense, straight legs; rigid and/or rapid extension, flexion STATE OF AROUSAL 0 Sleeping/Awake Quiet, peaceful sleeping or alert random leg movement 1 Fussy Alert, restless, and thrashing

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116 APPENDIX B NEONATAL INFANT PAIN SCALE DATA C OLLECTION SHEET NEONATAL/INFANT PAIN SCALE 1 min 2 min 3 min 4 min 5 min NNS 1 min 2 min 1 min 2 min 3 min 4 min 5 min SCORE SCORE SCORE SCORE SCORE ONNS SCORE SCORE SCORE SCORE SCORE SCORE SCORE Facial Expression 0=Relaxed Muscles 1=Grimace Cry 0=No Cry 1= Whimper 2=Silent Cry Breathing Patterns 0=Relaxed 1=Change in Breathing Arms 0=Relaxed/Restrained 1=Flexed/Extended Legs 0=Relaxed/Restrained 1=Flexed/Extended State of Arousal

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117 0=Sleeping/Awake 1=Fussy TOTAL TOTAL TOTAL TOTAL TOTAL TOTAL TOTAL TOTAL TOTAL TOTAL TOTAL TOTAL DATE TIME ID #

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118 APPENDIX C DATA COLLECTION SHEE T NNS and Sucrose Induced Analgesia Study Date Diagnosis Race Sex GA Age in Heart O2 NIPS Comments STAMP Days Rate Sats % 1 min 2 min Notes 3 min 4 min 5 min NNS 1 min 2 min STICK 1 min 2 min 3 min 4 min Legend 5 min Race Sex

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119 a=Caucasian M=male b=Black F=female c=Latin d=Indian e=Asian f=other

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120 APPENDIX D UNIVERSITY OF FLORIDA INFORMED CONSENT INFORMED CONSENT FORM to Participate in Research INTRODUCTION Name of person seeking your consent: Place of employment & position: This is a research study of providing a pacifier (nonutritive sucking) and sweetne r (sugar water) to your baby before, during, and after a routine heel stick ordered by a physician. Heart rate and oxygen saturation will be measured from the bedside monito rs. The pain score will be determined by the Principle Investigator through obser vation of your baby. Could participating in this study offer any direct benefits to you? Yes as described on page 123. Could participating cause you any discomforts or are there any risks to you? No as described on page 122. Please read this form which des cribes the study in some detail. I or one of my co workers will also describe this study to you and answer all of your questions. Your participation is entirely voluntary If you choose to participate you can change your mind at any time and withdraw from the study. Y ou will not be penalized in any way or lose any benefits to which you would otherwise be entitled i f you choose not to participate in this study or to withdraw If you have questions about your rights as a research subject, please call the University of Florida Institutional Review Board (IRB) office at (352) 8461494. If you decide to take part in this study, please sign this form on page Error! Bookmark not defined. GENERAL INFORMATION ABOUT THI S STUDY 1. Name of Participant ("Study Subject") ___________________________________________________________________

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121 2. What is the Title of this research study? Nonnutritive Sucking and Sucrose -Induced Analgesia: Effect on Heart Rate, O xygen Saturation, and Pain in Intubated Infants 3. Who do you cal l if you have questions about this research study? Harriet D. Miller, PhD (c), ARNP; Principle Investigator; beeper: 407-980-5149, cell: 354-514-9100 4. Who is paying for this research study? The sponsor of this study is no one 5. Why is this research study being done ? The purpose of this research study is t o examine the effect of a pacifier (nonnutriti ve sucking) with sucrose (sweetner) on your babys heart rate, oxygen saturation, and level of discomfort before, during, and after a routine, ordered heel stick. Two heel sticks will be observed, one with the pacifier and sweetner, and one without. The heel sticks are part of routine, standard care ordered by a physician for needed laboratory results. The heel sticks are not obtained only for the purpose of this research. You are being asked to be in this research study because your infant in intubated and has routine heelsticks performed. WHAT CAN YOU EXPECT IF YOU PARTICIPATE IN THIS STUDY? 6. What w ill b e done as part of your normal clinical care (even if you did not participate in this research study )? Nothing different will be done as part of your normal clinical care. 7. What will be done only because you are in this research study ? Babies who are intubated are not usually offered a pacifier for comfort measures. If you give permission for your baby to be in this s tudy, your baby will be offered a pacifier with sweetner before, during, and after a routine, ordered heel stick. Your babys heart rate and oxygen saturation will be recorded by monitors that are already attached. Your babys behavior will be recorded b y the Principal Investigator. No heel sticks will be done for research purposes only, but rather are part of routine, standard care. Perhaps this information will help care givers in providing care. If you have any questions now or at any time during the study, please contact Harriet Miller, PhD (c), ARNP in question 3 of this form. 8. How long will you be in this research study?

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122 Each baby will be observed twice during a heel stick; once with a pacifier with sweetner, and once without a pacifier with sweetner. The time for observation for each heel stick will be 5 minutes before the heel stick, during the heel stick, and for 5 minutes after the heel stick. The heel sticks are part of routine, standard care ordered by a physician for needed laboratory results. The heel stick s are not obtained for the purposes of this research only. 9 How many people are expected to take part in this research study ? Up to 16 babies. WHAT ARE THE RISKS AND BENEFITS OF THIS STUDY AND WHAT ARE YOUR OPTIONS? 10. What are the possible discomforts and risks from taking part in this research study ? There are no anticipated risks or possible disc omforts to your baby for taking part in this study. The heel stick is used to provide standard care. The researcher will take appropriate steps to protect any information collected. However, there is a slight risk that information about your baby could be revealed inappropriately or accidentally. Depending on the nature of the information such a release could upset or embarrass you, or possibly even affect your insurability or employability. Question 17 in this form discusses what information about yo ur baby will be collected, used, protected, and shared. Other p ossible risks to y ou may include: There are no anticipated risks to your baby for taking part in this study. This study may include risks that are unknown at this time. Participation in more than one research study or project may further increase the risks to you. If you are already enrolled in another research study, p lease inform Harriet Miller, PhD (c), ARNP (listed in question 3 of this cons ent form) or the person reviewing this consent with you before enrolling in this or any other research study or project. Throughout the study, the researchers will notify you of new information that may become available and might affect your decision to r emain in the study. If you wish to discuss the information above or any discomforts you may experience, please ask questions now or call the name of PI or contact person listed on the front page of this form.

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123 1 1 a. What are the potential benefits to you f or taking part in this research study ? It is not known if your baby will benefit from this study. However, it is hoped that the use of a pacifier with sweetner will make your baby more comfortable. 1 1 b. How could others possibly benefit from this study ? It is hoped that if pacifiers w ith sweetner help in painful situations, other babies will be provided with a sweetened pacifier to help alleviate distress in clinical practices. 11c. How could the researchers benefit from this study? In general, presenting research results helps the c areer of a scientist. Therefore, Harriet Miller, PhD (c), ARNP may benefit if the results of this study are presented at scientific meetings or in scientific journals. 1 2 What other choices do you have if you do not want to be in this study? You do not have to participate in this study and routine care will be provided for your infant. 1 3 a. Can you withdraw from this study? You are f ree to withdraw your consent and to stop participating in this study at any time. If you do withdraw your consent, you will not be penalized in any way and you will not lose any benefits to which you are entitled. If you decide to withdraw your consent to participate in this study for any reas on, please contact Harriet Miller, PhD (c), ARNP at (cell) 352-514-9100, or (beeper)407980-5149. They will tell you how to stop your participation safely. If you have any questions regarding your rights as a research subje ct, please call the Institutional Review Board (IRB) office at (352) 846-1494. 1 3 b. If you withdraw, can information about you still be used and/or collected? No 1 3 c. Can the Principal Investigator withdraw you from this study? You may be withdrawn from the study without your consent for the following reasons: If your babys condition does not allow him or her to suck the pacifier.

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124 WHAT ARE THE FINANCIAL ISSUES IF YOU PARTICIPATE? 14. If you choose to take part in this research study, will it cost you anything? No 1 5 Will you be paid for taking part in this s tudy? No 1 6 What if you are injured because of the study?

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125 Please contact the Principal Investigator listed in question 3 of this form if you experience an injury or have questions about any discomforts that you experience while participating in this study. 17. How will your privacy and the confidentiality of your research records be protected? Information collected about you will be stored in locked filing cabinets or in computers with security passwords. Only certain people have the legal right to review these research records, and they will protect the secrecy (confidentiality) of these records as much as the law allows. These people include the researchers for this study, certain University of Florida officials, the hospital or clinic (if any) involved in this research, and the Institutional Review Board (IRB; an IRB is a group of people who are responsible for looking a fter the rights and welfare of people taking part in research) Otherwise your research records will not be released without your permission unless required by law or a court order. Researchers will take appropriate steps to protect any information they collect about you. However there is a slight risk that information about you could be revealed inappropriately or accidentally. Depending on the nature of the information such a release could upset or embarrass you, or possibly even affect your insurabi lity or employability. If the results of this research are published or presented at scientific meetings, your identity will not be disclosed.

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126 SIGNATURES As a n investigator or the investigators representative, I have explained to the participant the purpose, the procedures, the possible benefits, and the risks of this research study; the alternatives to being in the study; and how privacy will be protected : Signature o f Person Obtaining Consent Date You have been informed about this studys purpose, procedures, possible benefits, and risks; the alternatives to being in the study; and how your privacy will be protected. You have received a copy of this Form. You ha ve been given the opportunity to ask questions before you sign, and you have been told that you can ask other questions at any time. You voluntarily agree to participate in this study. By signing this form, you are not waiving any of your legal rights. Signature of Person Consenting Date

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127 APPENDIX E ORLANDO REGIONAL INFORMED CONSENT Page 1 of 5 INFORMED CONSENT FORM Nonnutritive Sucking and Sucrose -Induced Analgesia: Effect on Heart Rate, Oxygen Saturation, and Pain in Intubated Infants Good medical care includes obtaining informed consent before beginning any experimental procedure. The patient or subject should be told the nature, purpose, alternative and possible side effects of the therapy. This experimental research study is being cond ucted by Harriet D. Miller, PhD (c), ARNP. Principal Investigator(s): Harriet D. Miller, PhD (c) ARNP Sub Investigator(s): Charlene Krueger, PhD Robert Baum, PhD Sandra Seymour, PhD Josephine Snider, EdD Investigational Site(s): Winnie Palme r Hospital for Women and Babies This consent form gives detailed information about the research study. Your doctor will discuss this information with you. Once you understand the study, you will be asked to sign this form if you wish to participate. 1 PURPOSE OF RESEARCH STUDY : The purpose of the research study is to examine the effect of a pacifier (nonnutritive sucking) with sucrose (sweetner) on your babys heart rate, oxygen saturation, and level of discomfort before, during, and after a routine h eel stick. Two heel sticks will be observed, one with the pacifier and sweetner, and one without. The heel sticks are part of routine, standard care ordered by a doctor for needed laboratory results. The heel sticks are not obtained only for the purpose of this research. Your baby is being asked to be in this research study because he or she is intubated and has routine heel sticks performed. 2. EXPECTED DURATION : Each baby will be observed twice during a heel stick; once with a pacifier w ith sweetner, and once without a pacifier with sweetner. The time for observation for each heel stick will be 5 minutes before the heel stick, during the heel stick, and for 5 minutes after the heel stick. The heel sticks are part of routine, standard ca re ordered by a physician for needed laboratory results. The heel sticks are not performed for the purposes of this research only. 3. PROCEDURES TO BE FOLLOWED: Information will be collected from the baby by the same researcher and transcr ibed onto data collection sheets. Information will include age, sex race diagnosis, weight, length of admission, and any surgical history.

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128 Confidentiality will be maintained throughout. Following informed consent, and an order for a heelstick for a blood sample by the physician, the heart rate and oxygen saturations will be collected from printed recordings at the bedside monitor every 30 seconds before, during, and after the hee lstick. The Principle Investigator will record the Pain Score by observin g the baby every minute before, during, and after the heel stick. A pacifier with a sweetner will be offered to the baby to see if the calming effects of the pacifier is helpful. 4. IDENTIFICATION OF EXPERIMENTAL PROCEDURES: Offering a pacifier with a s w eetner to a baby on a breathing machine ( ventilator ) is not the usual standard of care 5. POTENTIAL RISKS AND DISCOMFORTS: The treatment used in this program may cause some or none of the side effects listed. In addition, there is always the ris k of very uncommon or unknown side effects occurring. The doctor may prescribe medication to keep the side effects under control. The use of medication could result in added costs. Neither Orlando Regional Healthcare System, Inc., nor the Investigator(s ) are financially responsible for these costs). 6. POTENTIAL BENEFIT TO SUBJECT OR OTHERS: Page 2 of 5 It is hoped that you (your baby s) participation in this research study will lead to knowledge that may help others who have similar condi tions. 7. ALTERNATIVE PROCEDURES OR TREATMENTS: T here is no alternative treatment other than not offering a pacifier with sweetner during a heel stick. 8a. CONFIDENTIALITY OF RECORDS: Your baby s study record will be kept in a confidential form at Winn ie Palmer Hospital. The confidentiality of your baby s record is carefully guarded. No information by which your baby can be identified will be published in any publication. No information by which your baby c an be identified will be released to any third party except as provided herein or as required by law. Representatives of the Food and Drug Administration (FDA) and the sponsor and their agents may have access to the study record, as well as your baby s me dical record, which may contain your baby s name, and the FDA may be required by law in certain circumstances to release information in its possession. 8b. AUTHORIZATION TO USE OR DISCLOSE PROTECTED HEALTH INFORMATION (PHI) FOR RESEARCH : The Federal Privacy Regulations explain how your babys health information will be used and to whom it will be disclosed (given to) for this research study. You will be provided with a copy of the Notice of Privacy Practices, which describes the Orlando Regional Healthc are System,

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129 Inc. privacy practices. Your babys protected health information may be used or disclosed for research purposes. The following protected health information will be collected during this study: Name, b irth date, p ersonal medical history, c urr ent and past medications, therapies, surgeries, procedures, i nformation from current and past physical examinations. Who may Use or Disclose your Protected Health Information? The following individuals / organizations may use or disclose your babys prote cted health information for this research study: Study doctor and the study staff Orlando Regional Healthcare Institutional Review Board University of Florida Institutional Review Board To whom may your Protected Health Information be Disclosed? As part of the study, the study doctor and the study staff may disclose the results of study related tests and procedures that may identify you to the following: Orlando Regional Healthcare Institutional Review Board Food and Drug Administration (FDA) Office for Human Research Protection (OHRP) In addition to the list of individuals and organizations to whom your Protected Health Information may be disclosed, others may receive the information that is not currently known. If information from your rec ords is given to any of these people, they might give it to someone else. If this happens, the information will no longer be protected. Someone Orlando Regional Healthcare gives the information to is supposed to protect it, but Orlando Regional Healthcar e cannot always keep that person from giving it to someone else. Your PHI may no longer be protected by the Federal Privacy Rule once it is disclosed by the study doctor to these other parties. B B y y a a g g r r e e e e i i n n g g t t o o p p a a r r t t i i c c i i p p a a t t e e i i n n t t h h i i s s r r e e s s e e a a r r c c h h s s t t u u d d y y a a n n d d s s i i g g n n i i n n g g t t h h i i s s i i n n f f o o r r m m e e d d c c o o n n s s e e n n t t y y o o u u a a r r e e a a u u t t h h o o r r i i z z i i n n g g O O r r l l a a n n d d o o R R e e g g i i o o n n a a l l H H e e a a l l t t h h c c a a r r e e S S y y s s t t e e m m I I n n c c W W i i n n n n i i e e P P a a l l m m e e r r H H o o s s p p i i t t a a l l f f o o r r W W o o m m e e n n a a n n d d B B a a b b i i e e s s a a n n d d H H a a r r r r i i e e t t D D M M i i l l l l e e r r P P h h D D ( ( c c ) ) A A R R N N P P t t o o u u s s e e a a n n d d d d i i s s c c l l o o s s e e y y o o u u r r p p r r o o t t e e c c t t e e d d h h e e a a l l t t h h i i n n f f o o r r m m a a t t i i o o n n f f o o r r t t h h e e p p u u r r p p o o s s e e o o f f r r e e s s e e a a r r c c h h r r e e l l a a t t e e d d t t o o t t h h i i s s s s t t u u d d y y O O n n l l y y t t h h e e s s m m a a l l l l e e s s t t a a m m o o u u n n t t o o f f p p r r o o t t e e c c t t e e d d h h e e a a l l t t h h i i n n f f o o r r m m a a t t i i o o n n n n e e c c e e s s s s a a r r y y w w i i l l l l b b e e u u s s e e d d

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130 T T h h e e r r e e i i s s n n o o e e x x p p i i r r a a t t i i o o n n d d a a t t e e f f o o r r t t h h e e u u s s e e o o f f y y o o u u r r h h e e a a l l t t h h i i n n f f o o r r m m a a t t i i o o n n f f o o r r t t h h i i s s r r e e s s e e a a r r c c h h s s t t u u d d y y I I t t m m a a y y b b e e u u s s e e d d u u n n t t i i l l a a l l l l f f o o l l l l o o w w u u p p p p r r o o c c e e d d u u r r e e s s a a n n d d a a l l l l r r e e s s e e a a r r c c h h / / d d a a t t a a c c o o l l l l e e c c t t i i o o n n h h a a s s b b e e e e n n c c o o m m p p l l e e t t e e d d I I t t m m a a y y a a l l s s o o b b e e u u s s e e d d P P a a g g e e 3 3 o o f f 5 5 u u n n t t i i l l t t h h e e f f e e d d e e r r a a l l r r e e g g u u l l a a t t o o r r y y a a g g e e n n c c y y c c h h e e c c k k t t h h a a t t t t h h e e d d a a t t a a r r e e q q u u i i r r e e m m e e n n t t s s h h a a v v e e b b e e e e n n m m e e t t Y Y o o u u r r b b a a b b y y s s h h e e a a l l t t h h i i n n f f o o r r m m a a t t i i o o n n m m a a y y b b e e u u s s e e d d i i n n f f u u t t u u r r e e a a d d d d i i t t i i o o n n a a l l r r e e c c h h e e c c k k i i n n g g o o f f d d a a t t a a a a c c c c u u r r a a c c y y ( ( c c o o r r r r e e c c t t n n e e s s s s ) ) A A t t t t h h e e t t i i m m e e t t h h a a t t y y o o u u r r b b a a b b y y s s r r e e c c o o r r d d s s n n o o l l o o n n g g e e r r n n e e e e d d t t o o b b e e c c h h e e c c k k e e d d O O r r l l a a n n d d o o R R e e g g i i o o n n a a l l H H e e a a l l t t h h c c a a r r e e w w i i l l l l d d e e s s t t r r o o y y ( ( s s h h r r e e d d ) ) y y o o u u r r b b a a b b y y s s r r e e s s e e a a r r c c h h r r e e c c o o r r d d s s A A d d d d i i t t i i o o n n a a l l i i n n f f o o r r m m a a t t i i o o n n a a b b o o u u t t c c o o n n f f i i d d e e n n t t i i a a l l i i t t y y o o f f a a n n d d a a c c c c e e s s s s t t o o y y o o u u r r b b a a b b y y s s p p r r o o t t e e c c t t e e d d h h e e a a l l t t h h i i n n f f o o r r m m a a t t i i o o n n w w h h i i l l e e y y o o u u r r b b a a b b y y p p a a r r t t i i c c i i p p a a t t e e s s i i n n t t h h i i s s r r e e s s e e a a r r c c h h s s t t u u d d y y : : I I f f y y o o u u r r d d o o c c t t o o r r w w i i s s h h e e s s t t o o u u s s e e y y o o u u r r b b a a b b y y s s i i d d e e n n t t i i f f i i a a b b l l e e i i n n f f o o r r m m a a t t i i o o n n f f o o r r a a n n y y o o t t h h e e r r r r e e a a s s o o n n t t h h a a n n t t h h i i s s r r e e s s e e a a r r c c h h s s t t u u d d y y h h e e / / s s h h e e m m u u s s t t g g e e t t y y o o u u r r p p e e r r m m i i s s s s i i o o n n f f o o r r t t h h a a t t p p u u r r p p o o s s e e Y Y o o u u m m a a y y w w i i t t h h d d r r a a w w y y o o u u r r p p e e r r m m i i s s s s i i o o n n t t o o u u s s e e y y o o u u r r b b a a b b y y s s p p r r o o t t e e c c t t e e d d h h e e a a l l t t h h i i n n f f o o r r m m a a t t i i o o n n b b y y t t a a l l k k i i n n g g w w i i t t h h y y o o u u r r d d o o c c t t o o r r o o r r r r e e s s e e a a r r c c h h s s t t a a f f f f a a n n d d m m a a k k i i n n g g a a r r e e q q u u e e s s t t i i n n w w r r i i t t i i n n g g U U s s e e a a n n d d r r e e l l e e a a s s e e o o f f i i n n f f o o r r m m a a t t i i o o n n t t h h a a t t w w a a s s a a l l r r e e a a d d y y g g a a t t h h e e r r e e d d m m a a y y c c o o n n t t i i n n u u e e w w h h e e n n n n e e c c e e s s s s a a r r y y i i n n c c h h e e c c k k i i n n g g a a n n d d r r e e p p o o r r t t i i n n g g i i m m p p o o r r t t a a n n t t e e v v e e n n t t s s ( ( s s u u c c h h a a s s a a c c c c o o u u n n t t i i n n g g f f o o r r y y o o u u r r w w i i t t h h d d r r a a w w a a l l f f r r o o m m t t h h e e s s t t u u d d y y a a d d v v e e r r s s e e e e v v e e n n t t s s r r e e p p o o r r t t e e d d t t o o t t h h e e F F D D A A t t o o m m o o n n i i t t o o r r s s a a f f e e t t y y o o f f p p a a r r t t i i c c i i p p a a n n t t s s o o r r f f e e d d e e r r a a l l r r e e g g u u l l a a t t o o r r y y a a g g e e n n c c y y a a u u d d i i t t s s ( ( r r e e v v i i e e w w s s ) ) I I f f y y o o u u w w i i t t h h d d r r a a w w y y o o u u r r p p e e r r m m i i s s s s i i o o n n t t o o u u s s e e y y o o u u r r b b a a b b y y s s h h e e a a l l t t h h i i n n f f o o r r m m a a t t i i o o n n n n e e i i t t h h e e r r O O r r l l a a n n d d o o R R e e g g i i o o n n a a l l H H e e a a l l t t h h c c a a r r e e S S y y s s t t e e m m I I n n c c n n o o r r H H a a r r r r i i e e t t D D M M i i l l l l e e r r P P h h D D ( ( c c ) ) A A R R N N P P w w i i l l l l r r e e l l e e a a s s e e i i n n f f o o r r m m a a t t i i o o n n c c o o l l l l e e c c t t e e d d a a f f t t e e r r y y o o u u r r w w i i t t h h d d r r a a w w a a l l t t o o a a n n y y o o t t h h e e r r t t h h i i r r d d p p a a r r t t y y I I f f y y o o u u w w i i t t h h d d r r a a w w y y o o u u r r p p e e r r m m i i s s s s i i o o n n t t o o u u s s e e a a n n d d r r e e l l e e a a s s e e y y o o u u r r b b a a b b y y s s h h e e a a l l t t h h i i n n f f o o r r m m a a t t i i o o n n y y o o u u w w i i l l l l n n o o l l o o n n g g e e r r b b e e a a b b l l e e t t o o p p a a r r t t i i c c i i p p a a t t e e i i n n t t h h e e s s t t u u d d y y H H o o w w e e v v e e r r i i f f y y o o u u d d e e c c i i d d e e t t o o w w i i t t h h d d r r a a w w f f r r o o m m t t h h e e s s t t u u d d y y y y o o u u w w i i l l l l n n o o t t b b e e p p e e n n a a l l i i z z e e d d o o r r l l o o s s e e b b e e n n e e f f i i t t s s t t o o w w h h i i c c h h y y o o u u a a r r e e o o t t h h e e r r w w i i s s e e e e n n t t i i t t l l e e d d Y Y o o u u r r d d o o c c t t o o r r m m a a y y d d i i s s c c u u s s s s o o t t h h e e r r r r e e s s e e a a r r c c h h p p r r o o j j e e c c t t s s w w i i t t h h y y o o u u i i f f h h e e / / s s h h e e t t h h i i n n k k s s t t h h e e o o t t h h e e r r p p r r o o j j e e c c t t s s r r e e l l a a t t e e t t o o y y o o u u r r b b a a b b y y s s c c o o n n d d i i t t i i o o n n H H o o w w e e v v e e r r y y o o u u r r b b a a b b y y s s h h e e a a l l t t h h i i n n f f o o r r m m a a t t i i o o n n c c a a n n n n o o t t b b e e g g i i v v e e n n t t o o a a n n o o t t h h e e r r d d o o c c t t o o r r o o r r s s p p o o n n s s o o r r f f o o r r t t h h e e r r e e a a s s o o n n o o f f a a s s k k i i n n g g y y o o u u t t o o e e n n r r o o l l l l y y o o u u r r b b a a b b y y i i n n a a n n o o t t h h e e r r r r e e s s e e a a r r c c h h s s t t u u d d y y You have the right to inspect (look over) and obt ain a copy of your babys health information that is kept for research purposes for as long as this information is held by your study doctor or Orlando Regional Healthcare System, Inc. However, to ensure the integrity of the research, you will not be able to review some of the study information until the end of the study. 9. COMPENSATION: There is no financial compensation for participation in this study. 10. RESEARCH RELATED INJURY: In the event that injury occurs as a result of this research, treatment will be available. However, you will not be reimbursed by Orlando Regional Healthcare System Inc. or the investigator for these costs. For more information about your babys rights as a research subject, you may call the Institutional

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131 Review Board Office at (321) 8415895. The doctor involved in your babys care is available to answer any questions you have concerning participation in this research program. You are free to ask the investigator Harriet D. Miller, PhD (c), ARNP at Ph # (321) 841-8332 any questions concerning this research study that you have now or in the future. 11. VOLUNTARY PARTICIPATION: You are free to refuse or stop participation in this research study at any time without penalty or loss of benefits to which you are otherwise entitled You are free to seek care from a physician of your choice at any time. If you do not take part in or withdraw from the study, your baby may continue to receive care for which you will be financially responsible. 12. ADDITIONAL RISKS: Participation in this study may involve risks to the subject which are currently unforeseeable. 13. INVOLUNTARY TERMINATION: Your babys participation in this study may be stopped by the investigator under the following circumstances: not able to suck on pacifier. 14. PROCE DURES FOR WITHDRAWAL : When your baby completes the study or should you for any reason stop your babys participation in the study, your baby will not be followed after the completion of or withdrawal from the study. 15. NEW FINDINGS: Significant new findi ngs developed during the course of the research which may relate to your willingness to continue your babys participation will be provided to you. Page 4 of 5 16. NUMBER OF PARTICIPANTS: The approximate number of babies involved in the study at this site will be 14. 17. ADDITIONAL COST: No additional cost to the baby will result from participation in the research study. 18. FINANCIAL DISCLOSURE: This clinical research study is paid for by the investigator.

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132 Nonnutritive Sucking and Sucr ose -Induced Analgesia: Effect on Heart Rate, Oxygen Saturation, and Pain in Intubated Infants 19. SIGNATURES: My signature indicates that I consent and authorize and whomever he (she) may designate as his (her) assistant(s) including Orlando Regional Healthcare System, Inc., its employees and its agents to perform upon (name of patient or myself) the research described above. If any unforeseen conditions arise in the course of the research calling in the Doctors judgment for procedures in addit ion to or different from those planned, I (we) further request and authorize the Doctor to do whatever he (she) deems advisable. I AM MAKING A DECISION WHETHER OR NOT TO PARTICIPATE (OR HAVE MY CHILD PARTICIPATE) IN THIS STUDY. I HAVE READ, OR HAD READ T O ME IN A LANGUAGE THAT I UNDERSTAND, ALL OF THE ABOVE, ASKED QUESTIONS, RECEIVED ANSWERS CONCERNING AREAS I DID NOT UNDERSTAND, AND WILLINGLY GIVE MY CONSENT TO PARTICIPATE IN THIS STUDY. UPON SIGNING THIS FORM I WILL BE GIVEN A COPY. Sign ature of Subject, Parent or Legal Representative Date Signature of Witness Date I have explained and defined in detail the research procedure in which the patient has consented to participate. Investigators Signatu re Date Translator/Interpreter Name__________________________________ Phone#___________________________ Address_______________________________________________________________________ ________

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133 For Signatures by Parent, Guardian, or Legal Representative, please describe the authority to act on behalf of the participant below:

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137 Gibbins, S., & Stevens, B. (2001). State of the art pain assessment and management in highrisk infants. Newborn and Infant Nursing Reviews, 1 (2), 8596. Gibbins, S, Stevens, B., Hodnett, E., Pinelli, J., Ohisson, A., & Darlington, G. (2002). Efficacy and safety of sucrose for procedural pain relief in preterm and term neonates. Nursing Research, 51 (6), 375382. Gill, N. (1992). Nonnutritive sucking modulates behavioral state for preterm infants before feeding. Scandinavian Journal of Caring Sciences, 6, 3 7. Grunau, R. (2000). Long-term consequences of pain in human neonates. In Anand, K. & McGrath, B. Pain in neonates Vol. 10: Pa in and research clinical management (pp. 90 91). Amsterdam: Elsevier. Grunau, R. (2002). Early pain in pre term infants. A model of long-term effects. Clinics in Perinatology, 29(3), 373394. Hair, J., Anderson, R., Tatham, R., & Black, W. (1998). Multivar iate data analysis Prentice Hall: New Jersey. Hamers, J. P., Abu -Saad, H. H., Halfens, R. J., & Schumacher, J. N. (1994). Factors influencing nurses pain assessment and intervention in children. Journal of Advanced Nursing, 20(5), 853860. Hamers, J. P ., Abu -Saad, H. H., van den Hout, M., Halfens, R. J., & Kester, A. (1996 ). The influence of childrens vocal expressions, age, medical diagnosis, and information obtained from parents on nurses pain assessments and decisions regarding interventions. Pain 65(1), 5361. Harrison, D., Johnston, L., & Loughnan, P. (2003). Oral sucrose for procedural pain in sick hospitalized infants: A randomized -controlled trial. Journal of Paediatrics and Child Health, 39, 591597. Hatfield, L. (2008). Sucrose decreases i nfant biobehavioral pain response to immunizations: A randomized controlled trial. Journal of Nursing Scholarship, 40(3), 219225. Helms, J. & Barone, C. (2008). Physiology and t reatment of p ain. Critical Care Nurse, 28 (6), 3849. Herschel, M. Khoshnood, B. Ellman, C., Maydew, N. & Mittendorf, R. (1998). Neonatal circumcision. Archives of Pediatric Adolescent Medicine, 152 279284. Homer, C. J., Marino, B., Cleary, P. D., Alpert, H. R., Smith, B., Ganser, C. M., Brustowicz, R. M., & Goldman D. A. (199 9). Quality of care at a childrens hospital. Archives of Pediatric and Adolescent Medicine, 153, 11231129. Hultgren, M. S. (1990). Assessment of postoperative pain in critically ill infants. Progressive Cardiovascular Nursing, 5(3), 104112.

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142 BIOGRAPHICAL SKETCH Harriet Miller was born in Spokane, Washin gton. She received her Bachelor of Science in Nursing from the University of Florida, and was inducted into the Alpha Theta Chapter of Sigma Theta Tau in 1982. She obtained a Masters of Science in Nursing in Critical Care as a Clinical Nurse Specialist, and later a post -masters degree as an Advanced Registered Nurse Practitioner in Pediatric Health from the University of Florida. She has worked in clinical and managerial roles in the acute and critical care areas of Pediatric and Neonatal Intensive Car e. Currently she is a doctoral candidate in Nursing with a minor in Bioethics at the University of Florida. Her past research has focused primarily on infant pain in the critical care setting. Currently she is the Clinical Nurse Specialist in Neonatal S ervices at Winnie Palmer Hospital for Women and Babies in Orlando, Florida.