THE RELATIONSHIP OF SPIRITUALITY AND SELF-HEALTH ASSESSMENT IN
PREDICTING POSTOPERATIVE PAIN AND ANALGESIC USE
PATRICIA A. MCNALLY
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
Patricia A. McNally
To my family.
There is no adequate way to thank my children, Jimmy, Meghan and Kerry. for all
of their support and love during my doctoral studies. I could not have completed this
work without their belief in me, the frequent phone calls, visits, and words of
encouragement. Lastly, I hope my grandchildren may you love and appreciate the
educational process with the wonder that I have experienced throughout my lifetime.
I would also like to thank my supervisory committee for their knowledge, guidance
and encouragement in supporting me. Especially, I would like to thank Sharleen
Simpson, my chair. Her constant patience and guidance and belief that "you can do this"
gave me such support throughout this doctoral process. Additionally, thanks go to
Hossein Yarandi for his valuable assistance in analyzing data, and to Dr. Donald Caton, a
teacher and friend, who has been a leader in relieving pain. Through his example, he
brings out the best in all of us. Finally, thanks go to Dr. Monika Ardelt who has pursued
research that includes the study of spirituality and geriatrics. I will always be indebted to
all of them for their direction.
I am grateful to Dr. Peter Gearen, Chairman, Orthopaedic Department, and Dr. Nik
Gravenstein, Chairman, Anesthesia Department, for their support in designing and
implementing this research. Additionally, I want to thank the Pre-Surgical Center
administration for supporting the importance of this research and providing access to
TABLE OF CONTENTS
A C K N O W L E D G M E N T S ................................................................................................. iv
L IST O F TA B LE S ........ .................... ...... .................... ........ .............. viii
ABSTRACT .............. .......................................... ix
1 IN TR OD U CTION ............................................... .. ......................... ..
Background and Significance ......................................................... .............. 3
Chronic Pain in the Older Adult ................................ ....... ...............3
Osteoarthritis and Chronic Joint Pain in the Older Adult...................................4
Total Joint A rthroplasty in the Older A dult ........................................ ...............5
Spirituality in Older A dults ............................................................................5
Sum m ary ...................................... ................................... .................... 7
Specific A im s........................................................ 7
T erm inology ................................................................. 8
2 REV IEW OF TH E LITERA TU RE ...........................................................................10
Presence of Musculoskeletal Chronic Pain and Arthritis Among Older Adults ........10
The Relationship of Background Contextual Stimuli and Pain...............................11
A ge, Pain, and O steoarthritis..................................... ................... ...... ......... .. 11
Gender, Pain and Osteoarthritis..................... ..... ........................... 12
Age, Gender, and O steoarthritis ...................................................................... 12
R ace, Pain and O steoarthritis ........................................ ......................... 13
Total Joint A rthroplasty ......................................................................... .. 14
P re v a le n c e .................................................................................. 14
Gender and Arthroplasty .................................. .....................................15
R ace an d A rthroplasty ........................................... ........................................ 16
S p iritu al C o p in g ............ ....... ........................................................ .. .... .. .. .. .. 16
Spiritual C oping and H health ........................................................... .................. 18
Relationships between Spiritual Beliefs, Gender and Race .............................21
Roy Adaptation Model-Based Research .................................. ...............22
Roy Adaptation Model Gerontologic Research ...............................................23
S u m m a ry ......................................................................................................2 4
3 M E T H O D S ....................................................... 25
R e se arch D e sig n ................................................................................................... 2 5
Controls ................................ ..... ................25
Pow er Analysis and Sam ple Size ............................................. ............... 26
Procedures ............................ ................ 26
Protection of Human Subjects .......................... .................. ........ 27
Method .......................... ..............................27
Measures .......... ... ..... ......... .. ...............28
Preoperative Questionnaire M measures ...................................... ............... 28
Indicator of spirituality .......................................... .............................. ... 28
Indicator of self-health assessm ent ................................... ............... ..28
Indicator of ethnicity .............................................. ........ .......... .. ..29
Postoperative Data Collection Procedures .................................. ............... 29
D ata A n aly sis ............................................................. ..................... .. 1
S u m m a ry ................................ ....................................................3 2
4 R E S U L T S .............................................................................3 3
Sam ple Characteristics ........................................ ............................... 33
R regional A nesthesia ................... .............. ............ .. ...... ... ........ .... 34
Anesthesia Technique During Surgery ............. .................... .................34
Analysis of Data in Relation to the Hypotheses............................. ..............35
H y p oth esis 1 ........................................................................3 5
H hypothesis 2 .......................................................................35
H hypothesis 3 .......................................................................36
A additional Findings .......................................... ... .... ........ ......... 36
The Short Form -36 H health Survey ........................................ ......... ............... 37
5 D ISCU SSIO N ............. ........... .... ......... .. ........... ............ ... 45
R research F in ding s........... .................................................................... ........ .. ...... .. 4 5
Sample Characteristics ................................ ........ .. ...................45
Impact of Health Assessment and Spirituality on Pain Reports and Analgesic
M education U se ...................................... ........................... .... ........ ......48
C onclu sion s .................................................... ........................ 4 8
Strengths and Limitations....................................... ................... 49
Implications for Nursing Practice and Future Study .......................................50
A LETTER OF AGREEMENT................................................ ............... 53
B INFORMED CONSENT 08-19-03 TO 07-15-04 ................................................55
C INFORMED CONSENT 01-29-04 TO 07-15-04 ............................................... 63
D INFORMED CONSENT 07-16-04 TO 07-15-05 ............... ................... ............71
E THE SHORT FORM-36 HEALTH SURVEY-SPIRITUAL INVOLVEMENT
A N D B E L IE F S SC A L E ..................................................................... ..................78
LIST OF REFEREN CES ........ ......................................................... ............... 87
B IO G R A PH IC A L SK E TCH ..................................................................... ..................92
LIST OF TABLES
1 Frequency and Percent of Variables...................................................................... 38
2 Summary Measures of Variables ................................................... ................39
3 Pearson Correlation Coefficients-Spirituality and Variables with No
A dju stm en ts ...................................... ............................... ................ 3 9
4 Pearson Partial Coefficients-Controlling for Health Assessment ..........................39
5 Pearson Correlation Coefficients-Health Self-Assessment and Variables with No
A dju stm ents ...................................... ............................... ................. 4 0
6 Pearson Partial Coefficients-Health Self-Assessment and Variables Controlling
for Spiritu ality ........................................................................40
7 Frequencies and Percentages for Self- Reported SIBS Questionnaire (N=115). ....41
8 Frequencies and Percentages Questions that Indicated Ratings for General
Health, and Bodily Pain as Self-reported on the Short Form-36 Health Survey
questionnaire (N =1 15) .................. ..................................... .. ........ .. 43
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
THE RELATIONSHIP OF SPIRITUALITY AND SELF-HEALTH ASSESSMENT IN
PREDICTING POSTOPERATIVE PAIN AND ANALGESIC USE
Patricia A. McNally
Chair: Sharleen Simpson
Major Department: Nursing
The purpose of this descriptive study was to investigate relationships between
spirituality and self-heath with three postoperative outcomes after total hip or knee
arthroplasty in the older adult.
A total of 115 subjects between the ages of 55 and 86 years of age (M = 67.8) who
met the inclusion criteria were enrolled in this study. Forty-one were male and seventy-
four were female. One question from the Spiritual Involvement and Beliefs Scale and
one question from the Short Form-36 Health Survey were used to measure spirituality
and self-health assessment. Operative site, average daily pain scores, median daily pain
scores and analgesic medication use data were obtained from the patient's medical record
for three days postoperatively.
Bivariate analysis found that those participants with a high degree of spirituality
did not report less pain on days one (r = 0.01, p = 0.92), day two (r = 0.02, p = 0.84) or
day three (r = 0.03, p = 0.78). They also did not use less analgesic medication during the
three postoperative days (r = -0.04, p = 0.69). However, those participants who self-
assessed their health as good to excellent did have less pain on day one (r = 0.31, p =
0.00), day two (r = -0.29, p= 0.00) and day three (r = -0.22, p = 0.02). There was no
reduction in analgesic medication use (r = -0.11, p = 0.25). An ANOVA regression
found there was no relationship for a high degree of spirituality, a high self-health
assessment and the use of less pain medication (F = 1.04, p = 0.38).
The study supported the hypothesis that older adults who rate their self-health as
good, very good or excellent experienced less postoperative pain but this study did not
support less pain medication use. Second, this research did not support the hypothesis
that a participant's spirituality influences pain or analgesic medication use after
arthroplasty surgery. Third, a high degree of spirituality and good health together did not
make a difference in the amount of analgesic medication used for pain control.
The majority (81.7%) of the participants felt their health was good, very good or
excellent. Second, most (67%) indicated they were highly spiritual and 70% felt that
spiritual health contributes to physical health. Finally, the majority of the respondents
believe in spiritual coping behaviors such as prayer, belief in an afterlife and a personal
relationship with a greater power.
This research found that an individual who rates their self-health as good, very
good or excellent has less pain after arthroplasty surgery, but this self-health assessment
does not influence the use of pain medication. Although participants considered
themselves "highly spiritual", their spirituality did not influence postoperative pain or
pain medication use.
The increased number of aging persons has stimulated researchers to define the
concept of aging as viewed by older adults in our society. Rowe & Kahn, (1998) define
successful aging as the avoidance of disease and disability, social involvement and high
level of cognitive and physical function. Success, according to their definition, includes
few physical limitations, health, and the absence of chronic pain. Most adults over 55 yrs
of age do not report problems with daily activities such as: walking, bending and
stooping without assistance. In this age group, however, chronic pain can limit the level
of functional activity. A chief cause of chronic pain and disability among adults over 55
The experience of chronic pain in the elderly is both a physiologic and emotional
experience. Although rooted in sensory stimuli, pain also has an important overlay from
an individual's culture and experience (Porter, et al. 1996). Among all age groups pain
can be defined as an experience with both a sensory and emotional component, but for
the elderly adult, pain may signify a chronic condition that is not always managed
effectively with drug treatment. The most frequent cause of chronic pain and total
disability reported by the older adult is arthritis (Affleck, et al. 1999; Felson, 1988;
Mobily, Herr, Clark, & Wallace, 1994; Praemer, Fumer & Rice, 1999; Schlesinger,
The American Geriatrics Society suggests using both pharmocologic and non-
pharmocologic methods to achieve a greater degree of pain relief (American Geriatrics
Society, 1998; Gagliese & Melzak, 1997). Non-pharmocologic methods of pain control
include massage, acupuncture, and behavioral therapy. Keefe, et al. (2000) in a study of
rheumatoid arthritis and joint replacement, found that effective coping strategies included
praying, hoping and calming self-statements.
Research on the relationship of spirituality and health has gained increasing interest
in the academic and popular press over the past 15 years. Most early research used
retrospective data analysis to study the effects of religious affiliation, and hypertension,
depression, mortality, and anxiety (Clark, Friedman, & Martin, 1999; Husaini, Blasi, &
Miller, 1999; Koenig, George, Blazer, Pritchett, & Meador, 1993; Koenig, George,
Meador, Blazer, & Dyck, 1994). They observed a positive correlation between church
attendance and various correlates, such as hypertension, depression, anxiety, hospital
length of stay, and mortality (Koenig, et al. 1993; Koenig & Larson, 1998; Meador, et
Levin and Chatters (1998) suggest future quantitative studies to evaluate
relationships between spirituality and health. Although older people may rely more on
defensive coping strategies, the possibility that spiritual coping mechanisms may have a
therapeutic effect has not been explored. Such spiritual coping mechanisms might
include prayer, religious service attendance, and seeking a spiritual connection (Ellison &
Levin, 1998; Koenig & Larson, 1998; Pargament, Smith, Koenig, & Perez, 1998). These
studies suggest that older adults who use spiritual coping methods during stressful
medical conditions have a more positive health outcome.
I wished to explore the effect of spiritual belief, spiritual behavior and health self-
assessment on the response to postoperative pain. Towards this end I examined the
relationship between specific assessments of spiritual behavior, health self-assessment, to
reports of pain report and the use of analgesic medications among a group of older adults
recovering from hip replacements surgery.
Background and Significance
Chronic Pain in the Older Adult
Pain is defined as a noxious physical and emotional experience. Although similar
for all age groups, elderly adults appear to have a higher incidence of chronic pain. The
only measure of the presence and intensity of pain is the report of the person
experiencing the pain (Ferrell, 2000). Nociceptor pain, including chronic pain, begins
with the activation of special receptors and afferent fibers by peripheral stimuli usually
associated with processes involving tissue damage and inflammation (Ekblom & Rydh-
Rinder, 1998). Such pain may include musculoskeletal pain, ischemic pain, visceral pain,
and myofascial pain. There is little empirical evidence that biological or physiological
measurements correlates to the degree of pain expressed by the elderly individual
(Gagliese & Melzack, 1997). In other words, to a large extent the 'experience' of pain is
Among the elderly, research indicates that more than 90% of the elderly experience
pain in the musculoskeletal system (Anderson, Ejlertsson, Lenden & Rosenberg, 1993).
Chronic arthritic joint pain begins in the upper extremities such as shoulders and then
progresses to the lower extremity as an individual ages (Anderson, et al. 1993; Mobily ,
et al. 1994). This site of the pain can greatly affect severity of chronic pain as well as the
degree of functional impairment.
Osteoarthritis and Chronic Joint Pain in the Older Adult
Osteoarthritis is the most frequent cause of end stage joint deterioration and chronic
pain in the elder adult. In the early stage, there is only a pathologic loss of cartilage. As
the disease advances joint cartilage and underlying bone are affected, with a total loss of
cartilage and joint space. Joint cartilage serves two functions: 1) smooth frictionless
surface movement of articulating bones, and 2) transmission of the weight bearing load.
Additionally, extensive tissue inflammatory changes surround the affected joint and
contribute to the limitation of joint range of motion and severe chronic pain (Schlesinger,
2001). Visible osteophytes or lateral outgrowths of bone in the joint margins add to an
increased sclerosis of underlying bone that contributes to an additional increase in
functional impairment (Felson, 1988; Schlesinger, 2001). This loss of the articular
cartilage can be demonstrated radiographically as a joint space narrowing and
occasionally, osteophyte formation. The most frequently affected joint locations are
knees, hips, fingers, and spine (Praemer, et al. 1999).
Measurement of the impact of arthritis includes two parameters: disability or
functional impairment and economic health care system impact. The adult person 65
years of age with arthritis may have more limitations of activity than those afflicted with
other chronic disease states such as cardiac disease, diabetes, and cancer. It has been
estimated that 50% of those persons 65 years of age and older experience activity
limitation from the chronic pain of osteoarthritis (Mobily, et al. 1994). The failure of
conservative medical management, such as medications and physical therapy, in the
treatment of end stage joint osteoarthritis, has increased the demand for surgical total
Total Joint Arthroplasty in the Older Adult
The early 21st century has been declared the "Bone and Joint Decade" by 35 nations
and 44 states. Currently, more than 425,000 total joint replacements are performed each
year in the United States, and this number is expected to reach 702,000 by the year 2030
as the baby boomer generation ages (Praemer, et al. 1999). The increase in the number of
aging Americans, the increase in the prevalence of arthritis for this age group, and the
desire to remain active have added to the increase in demand for total joint replacement
surgery (Healy, Iorio, & Lemos, 2001). Joint replacement surgery has been documented
to improve pain, functional ability, social function, and quality of life for the recipient
(Aarons, Hall, Hughes, & Salmon, 1996; McGuigan, Hozack, Moriarty, Eng, &
Rothman, 1995; Norman-Taylor, Palmer, & Villar, 1996; Ritter, Albohm, Keating, Faris,
& Meading, 1995).
These findings demonstrate that osteoarthritis among older adults is a major cause
of chronic pain and functional impairment. Total joint replacement offers the older adult
pain relief and improved functional ability, particularly when there is failure with
Spirituality in Older Adults
Behavioral management of pain includes the strategy of active coping. Spiritual
coping behaviors that include praying and church attendance have been recognized as
active coping behavioral strategies used often by older adults (Koenig, et al. 1998).
Burkhardt, (1989) defines the "spirituality" as the individual's belief in God or a higher
power that is concerned with his or her striving to achieve a sense of harmony with self
and others. Spirituality often involves a relationship with an organized religion,
interrelationships with others, and the search for the meaning of life. Affiliation and/or
participation in organized religion, however, are not necessary to be considered spiritual
(Burkhardt, 1989; Principe, 1983). Different authors have defined 'spirituality' in
various ways. For the purpose of this discussion, I will use the "spirituality" to describe
the way of life an individual chooses that involves a belief in God or a higher power, a
belief in an after life, and a belief that a higher power influences life's events. I did not
limit this study to 'spirituality' associated with any specific religion or sect.
There has been an increasing interest in the interrelationship of spiritual
involvement, spiritual activity, and health outcomes among the elderly. Koenig,
McCullough, and Larson (2001) give three reasons for this current interest. First,
spirituality and religious affiliation continues to be a central part of people's lives despite
advances in technology, education, and medicine. Second, the United States and other
worldwide populations are aging due to a declining birth rate and greater longevity. In
the future, social programs will have severe financial hardships in providing services for
this population and religious groups may assist in providing some of these services.
There is the possibility that spiritual coping may aid in the prevention of health problems
and thereby assist in health care cost containment. Finally, there is a depersonalization in
the health care delivery system. Individuals seeking medical care and treatment expect
compassion with attention to their social, psychological, and spiritual needs. McFadden
and Levin (1996) summarize recent gerontologic spiritual research as focusing on four
areas of interest: "(a) multidimensional measures, (b) patterns, (c) predictors, and (d)
psychosocial and health related outcomes of religious involvement in older adults and
across the life course" (p. 350).
Many disciplines including medicine, psychology, and sociology have examined
the relationship of coping and religious affiliation; coping and spiritual beliefs; religious
attendance, and health outcomes like pain, depression, quality of life, mortality, and
morbidity. This investigator believes that the degree of spirituality in the post-surgical
older adult patient has not been considered in evaluating pain report and analgesic
medication use. Achieving adequate pain control is a major goal of professional nursing
care and utilizing spiritual coping may be an important addition in providing non-
pharmocologic pain management.
The purpose of this study is to explore whether a high degree of spirituality, and
high scores for self-health assessment are correlated with postoperative pain and
analgesic medication use in the acute hospital recovery phase. Currently, there is no
evidence in literature that has examined these variables and their relationship with the use
of postoperative pain medication after total joint arthroplasty. Prior research focused on
relationships of long-term functional rehabilitation, quality of life and spiritual coping.
Using two multidimensional instruments, I propose to address three important aims that
will contribute to the relationship of spirituality, self-health assessment, pain report and
analgesic medication use in the postoperative older adult joint arthroplasty patient.
First, using a multidimensional instrument, this study will investigate whether a
high degree of spirituality is associated with less pain report and medication use in older
individuals receiving primary hip or knee arthroplasty for osteoarthritis. It is the aim of
this research to determine whether older adults receiving a hip or knee arthroplasty with a
high score for spirituality on the Spiritual Involvement and Beliefs Scale (SIBS) will use
less analgesic medication postoperatively.
Second, the Short Form-36 Health Survey that measures general health assessment
will be used to measure self-health in this research. It is the aim of this research to
determine whether older adults with a high score for health self-assessment will use less
analgesic medication after controlling for spirituality.
Finally, the responses for both spirituality and self-health together will be
correlated with analgesic medication.
Hypothesis 1. Older adults with a higher degree of spirituality receiving a hip or
knee arthroplasty for primary osteoarthritis will report less pain and receive less analgesic
medication than those participants with a lower degree of spirituality after controlling for
Hypothesis 2. Older adults with high scores on the self-health assessment tool will
report less pain and receive less analgesic medication than those participants with low
scores on the self-health assessment tool after controlling for spirituality.
Hypothesis 3. There will be significantly less analgesic medication used by those
older adults receiving hip or knee arthroplasty who have a high degree of spirituality, and
a high degree of self-health assessment.
* Older adult: Age 55 or older
* Epidural: Medications administered to the epidural space surrounding the spinal
* Extrinsic religious orientation: The pursuit of religious beliefs and religious
practice to feel protected or gaining social status and approval.
* Femoral Nerve Sheath: Medication administered within the femoral nerve sheath
by means of a catheter to anesthetize the femoral nerve.
* Intrinsic religious orientation: The motivation to live the goals set forth by
religious tradition. The way of life often described as "living one's religion" and
using religious practices. The person who has an intrinsic religious orientation may
not be affiliated with a particular religious group.
* Medication Administration Record (MARS): Individual record of medication
administered to a patient during inpatient hospitalization. Each dose of medication
is recorded with the following data: medication name, dosage, time administered,
name of staff administering medication.
* Opioid equi-analgesic conversion: All narcotic medication was converted to
Morphine Sulfate IV equivalents.
* Patient controlled analgesia: Self-administered narcotic analgesia through an
* Religious affiliation: Participating in an organized religious group
* Spirituality: The way of life an individual chooses to live that internalizes a belief
in a higher power. These life thoughts are separate from the body and may involve
God, a belief in an afterlife, and belief that this higher power influences life's
* Spiritual behaviors: Praying, meditation and/or self-reflection, reading spiritual
* Visual Analog Scale (VAS): A pain rating scale adopted by Shands at the
University of Florida to provide accuracy in a patient's pain. The scale is numeric,
one = no pain and
* 10 = the worst pain of life. Patients are asked to rate their pain using numeric
increments 0 to 10.
REVIEW OF THE LITERATURE
This section deals with pertinent papers published during the past 20 years that
address chronic pain, osteoarthritis, lower extremity arthroplasty, and spirituality coping
among the elderly. The first section examines the prevalence of the chronic pain of
osteoarthritis and arthroplasty (focal stimuli), age, gender, and race (contextual stimuli).
The second reviews the relationship of spiritual coping to gender, race, age, and pain.
Presence of Musculoskeletal Chronic Pain and Arthritis Among Older Adults
Pain in the aged adult has become a focus of current gerontologic research. The
elderly have more painful diseases that require more medical visits. The impact of
musculoskeletal conditions on the elderly can be divided into two categories: 1) the
physical and social impact of physical pain (limitations in mobility and social interaction
imposed by these limitations), and 2) the monetary cost involved in the diagnosis and
treatment of these disorders (Praemer, Fumer, & Rice, 1992). Musculoskeletal disorders
after age 65, regardless of gender or racial group, are the most frequently reported
physical impairments, exceeded only by hearing disorders. Surgical intervention,
following failed medical management, is expected to increase dramatically in the next
twenty years (Praemer, et al. 1999). Musculoskeletal functional limitation has a
significant impact on the elderly.
Back and spine disorders are the most frequently reported category of dysfunction,
followed by lower extremity disorders of the hip or knee. Although there are many forms
of arthritis among the elderly, the two most common forms, those with the greatest public
health implications, are osteoarthritis and rheumatoid arthritis. The more prevalent of the
two forms, osteoarthritis, is estimated to affect 20 million people in the United States
(Praemer, et al.1999).
The Relationship of Background Contextual Stimuli and Pain
Age, Pain, and Osteoarthritis
Anderson, et al. (1993) found that 90% of individuals surveyed experienced
chronic musculoskeletal pain. Chronic pain symptoms increased between ages 50-64 and
then gradually declined. After age 60, however, the incidence of lower extremity pain
increased. Compared to younger adults, lower joint pain doubled after age 65 (Anderson,
et al. 1993; Gibson & Helme, 1995). In the Iowa study, Mobily, et al. (1994) observed a
lower incidence of overall pain (p< .0001) among those over 85 years compared to
younger age groups. They also found more than 86% of those surveyed experienced pain
longer than 12 months. Their research is felt to be particularly accurate because of their
large sample size and the longitudinal study design.
Several studies have examined the influence of age on pain sensitivity. Gibson and
Helme ((1995) examined sensitivity to several different forms of experimental pain using
a meta-analysis. Their data suggest a decline in thermal sensitivity after age 60, but do
not show a conclusive difference, or change, in pain sensitivity or pain tolerance. An
earlier study by Helme and Allen (1992) had found that the majority of those surveyed
(79%) agreed that pain was a consequence of the aging process. However, less than half
of these older adults reported pain. The authors concluded that older adults expected to
experience pain as they aged and they did.
Additional research is needed to evaluate both the physiologic and psychological
basis for pain among older adults. More effective management of pain in the older adult
originates in a better understanding of differences and similarities in the pain response.
Gender, Pain and Osteoarthritis
Experimental research has not demonstrated a conclusive difference in pain
perception related to gender. Using heat as a noxious stimulus in humans Paulson,
Minoshima, Morrow, and Casey (1998) concluded there was a gender similarity in the
cerebral and cerebellar activation, but anticipation of the stimulus was more intense in
Keefe, et al. (2000) measured pain, disability, and pain behavior among men and
women with a mean age of 61.1 yrs. They reported significant gender differences in pain
intensity, pain behavior, and physical disability associated with osteoarthritis. Women
had significantly elevated levels (F (1,166)= 4.41, P <0.05) of osteoarthritis pain. They
measured pain behavior, which included stiff movement, rubbing affected joint, and
flexing the joint, in relation to gender. In their analysis women exhibited more pain
behavior than men (F (1,162) = 5.54, P < 0.05). In a recent study of pain and coping,
Affleck et al. (1999) observed that women reported daily osteoarthritis pain and pain
levels 73% greater than males with a similar arthritis diagnosis. Results of these studies
have suggested that among the elderly, there is a difference in pain intensity related to
gender. Further research is necessary to compare noxious pain stimuli, pain thresholds
and intensity studied in younger populations to the older adult.
Age, Gender, and Osteoarthritis
Compared to males, females have twice the incidence of osteoarthritis. Until age
65, however, men report a greater occurrence of osteoarthritis. While men are more
likely to have shoulder, elbow and foot joint pain; women have finger, hip, ankle and
wrist joint pain (Davis, Ettinger, Newhaus & Hauck, 1987). Although specific affected
joint patterns have been identified as following a gender pattern, gender differences do
not contribute to risk factors for the development of osteoarthritis (Davis, et al.
1987;Keefe, et al. 2000; Lawrence, et al. 1998).
Race, Pain and Osteoarthritis
Differences in cultural response to pain have been studied using two methods, non-
experimental using observational methods, and laboratory experimental using painful
stimuli and measuring the response. Zatzick and Dimsdale (1990) were unable to
correlate cultural variations in pain response in their meta-analysis of pain stimuli and of
pain response. They concluded, "there is no evidence suggesting that the
neurophysiology detection of pain varies across cultural boundaries" (p.554). However,
Bates, Edwards, and Anderson (1993) using observational methods to evaluate the
differences in reported chronic pain intensity among seven diverse ethnic groups, found
significant correlations. Additionally, they investigated specific sociodemographic,
medical, and psychological variables that may predict an intra-ethnic group variation in
pain intensity. Bates, et al. (1993) found that pain intensity did not vary among various
ethnic groups because of differences in neurophysiology but was a result of the
biocultural model of pain perception.
European whites have a greater incidence of osteoarthritis than Jamaicans, Blacks,
South African Blacks, Chinese, and Indians (Felson, 1988). Rates for American Indians
are intermediate. There is speculation that individuals of European white descent have a
genetic developmental defect in both the knee and hip joints that facilitates the
development of osteoarthritis. This is supported by greater reporting of joint pain in
whites when compared to blacks or other races (Praemer, et al. 1992).
Total Joint Arthroplasty
The first decade 21st century has been declared the "Bone and Joint Decade" by 35
nations and 44 U.S. states. The number of lower extremity joint procedures has
increased; total knee replacements increased 40.2% during the years 1990 and 1996,
while total hip replacements increased 15.5% for the same years (Praemer, et al. 1999).
Currently more than 425,000 total joint replacements are performed in the United States,
and this number is expected to reach 702,000 by the year 2030 as the baby boomer
generation ages (Praemer, et al. 1999).
The leading reason for joint replacement surgery in the elderly is failure of
conservative medical treatment for end stage arthritic joints. The increase in the number
of aging Americans, and the increase in prevalence of arthritis for this age group along
with a strong desire to remain active have continued to increase the demand for total joint
arthroplasty (Healy, Iorio, & Lemos, 2001). Joint replacement surgery has been shown to
improve pain, functional ability, social function, and quality of life (Aarons, et al. 1996;
McGuigan, et al. 1995; Norman-Taylor, et al. 1996; Ritter, et al. 1995).
The goal of total joint arthroplasty is to recreate the motion of flexion, extension,
adduction, and rotation of the joint that has lost range of motion. This surgical
intervention demonstrates a ten-year success rate for 98 % of elderly individuals while
relieving joint pain and correcting the joint deformity. For patients with bilateral knee
joint end stage arthritis, bilateral joint replacements are often performed at the same time
(Pellino, Preston, Bell, Newton, & Hansen, 2002).
Total hip arthroplasty (THA) is a surgical procedure that replaces a diseased joint
with a synthetic joint using a synthetic acetabulum, femur, and polyethylene liner that are
fixed to bone by cement or bone ingrowths. Total knee arthroplasty (TKA) involves
replacing the femoral and tibia sides of the joint using a long or short stem fixated by
cement. The goal of joint arthroplasty is to improve function with an artificial joint that
improves range of motion and provides pain relief with few surgical complications
(Brander, Mullarkey, & Stulberg, 2001). The decision making process in considering a
candidate for total joint replacement is the degree of radiographic changes and the degree
of functional impairment.
Gender and Arthroplasty
Although women have 1.5-2.0 higher incidence of osteoarthritis, men have more
total knee arthroplasty than women. Katz, et al. (1994) suggests that gender differences
in joint arthroplasty are difficult to evaluate because procedure rates are not reported by
severity of disease. The authors evaluated functional status using a daily living scale that
evaluates the ability to walk several blocks, climb stairs, or take part in vigorous activity.
Greater functional impairment and the use of walking support were reported for most of
the females. The authors suggest that males have earlier surgical intervention for
functional impairment and pain. Praemer, et al. (1999) do report that the number of total
knee replacements for men in 1996 was 1318/100,000 while for women in the same year
it was 928/ 100,000. There is some evidence that suggests women delay surgical
intervention out of fear of surgical failure, death or loss of function postoperatively.
Postponing surgical intervention can also be because of distrust of physicians and
hospitals, a reluctance to take risks and concern about caregiving responsibilities.
Conversely, males most reported concern is the length of rehabilitation time necessary for
the return of joint function (Ritter, et al. 1995).
Race and Arthroplasty
The relationship between race and arthroplasty has been poorly studied. A recent
study in a large county in Texas reported that Hispanics were under represented as
recipients for hip replacement surgery (Escalante, Espinosa-Morales, Del Rincon,
Arroyo, & Older, 2000). In their research, African Americans were also less likely than
Caucasians to receive arthroplasty surgery. Extensive review of research literature on
race and arthroplasty, however, revealed no evidence to suggest a disparity in race and
In summary, the number of total joint replacements increases dramatically for both
sexes after age 65 (Praemer, et al. 1999). The effect of this increase can be directly
attributed to the incidence of joint osteoarthritis, chronic pain and functional impairment
(Felson, 1988; Schlesinger, 2001). Women report greater functional impairment for all
activities of daily living and delay arthroplasty for a longer period of time. It is unclear
from previous research reasons for gender differences in osteoarthritis incidence or the
delay for surgical intervention. Previous research only verifies the age related changes of
osteoarthritis, functional impairment and the increase in total joint replacement surgery
for the relief of pain and improvement in physical function.
According to Lazarus, DeLongis, Folkman, and Gruen, (1985), "efficacy
expectations and appraisals refer to cognitions: fear and distress refer to emotional states
that includes cognitions" (p. 776). Stress is regarded as a complex variable and the
individual in his/her personal environment reflects the processing of these variables.
Good health and the absence of chronic pain represent a person's stable environment. An
individual's inability to maintain these environmental variables creates stress and fear.
Through evaluating the stressors and using defense strategies, a coping process will be
used to overcome the disruption in a person's environment (Lazarus et al, 1985). The
older adult uses cognitive interpretation to identify stressful health changes and uses more
defense strategies to cope. Diehl, Coyle, and Labouvie-Vief, (1996) found that compared
to younger people; there was a difference in the use of self-restraint by older adults rather
than aggression to cope with environmental stressors.
Religious behaviors such as prayer, religious service attendance and seeking
spiritual connection, are part of the individual's practice of spiritual or religious coping
(Ellison & Levin, 1998; Koenig & Larson, 1998; Pargament, et al. 1998). Researchers
have studied the various spirituality concepts: 1) Religious doctrine; 2) Religious
attendance; and 3) Religious affiliation.
Spirituality includes both the world of experience and the way of life a person lives
that is guided by religious doctrine (Principe, 1983). It is the continuous process of
integrating oneself in current and past experience and the effort of relating to others with
trust and understanding. Spirituality links self with a power greater than the individual.
It is most often associated with a religion that defines the divine and offers ways to relate
to the sacred (McFadden & Gerl, 1990). Fowler describes the persons life spiritual
development as a developmental psychological process that uses cognitive and emotional
synthesis of a sense of meaning and purpose in the life journey (Shulik, 1988).
Interest in research involving the relationship of spirituality and health has been
increasing over the past 15 years. Most existing research has focused on religious
affiliation and health status in hypertension, depression, mortality, and anxiety (Clark,
Friedman, Martin, 1999; Husaini, Blasi & Miller, 1999; Koenig, et al. 1993, 1994). The
examination of a possible therapeutic effect of spirituality in the postoperative joint
replacement patient has not been explored. Levin and Chatters (1998) suggest that in
order to establish a relationship between spirituality and health, research must use
evaluate a measurable medical effect of spirituality or religion and aging. This research
will hypothesize that a positive relationship does exist between the older adult's degree of
spirituality and self-health assessment.
Spiritual Coping and Health
There has been no published research demonstrating a relationship between
spiritual coping, health assessment, and post-surgical pain. Most empirical research has
focused on the relationships of spiritual coping, spiritual beliefs, spiritual involvement
and health outcomes in mental health, hypertension, depression, and anxiety. Matthews,
et al. (1998) reviewed the relationships of religious factors that included religious
attendance and mental health status. The focal areas of mental health status were coping
and recovery from illness. The authors concluded in their review there was strong
support for religious commitment and positive medical outcomes following serious
illnesses e.g. heart disease, cancer. Pargament, et al. (1998) using a spiritual well being
scale found there was a relationship between positive and negative patterns of religious
coping in young and elderly age groups. They measured three diverse sample groups
experiencing stressful life events. The first sample represented Oklahoma City residents
who were evaluated for religious coping after the federal building bombing. The second
sample involved college students who had experienced a significant negative event, such
as a death of a friend or family problems. The third sample group was hospitalized
patients over the age of 55 with moderately severe medical illness. Although, the
participants were of different ages and diverse life event stressors, a positive pattern of
religious coping was found among the three groups. Those participants with positive
religious coping patterns had less psychological anxiety and distress. Those individuals
with negative religious coping were associated with greater emotional distress, e.g.
depression, and reported poorer quality of life. Pargament and colleagues (1990),
extended their religious coping research to more clearly identify the kinds of religious
beliefs, and behaviors that are helpful to individuals as they cope with negative life
events like death, illness, divorce and work related problems. Four separate themes of
religious beliefs and behaviors emerged to further define spiritual beliefs and practice: 1)
belief in a fair and loving God; 2) partnership with God is supportive; 3) positive
outcomes come from using of religious rituals; and 4) search for spiritual and personal
support through religious affiliation. Pargament, et al. (1990) explains nonreligious
avoidance with descriptor items from personal narratives such as "tried not to think about
it," "wished the situation would go away" (p. 818).
Using retrospective demographic data collection, early research that focused on
religious affiliation and health status demonstrated positive relationships between
religious affiliation and various health correlates, such as hypertension control,
depression, anxiety, length of hospital stay and mortality (Koenig, et al. 1993; 1998;
Koenig & Larson, 1998; Meador, et al. 1992). In a review of 20 empirical studies, Levin
& Vanderpool (1990) concluded that religion is therapeutically beneficial in the control
of hypertension. Koenig, et al. (1998) investigated the relationship of religious activities
and blood pressure control among older adults dwelling in communities. They concluded
that religiously active adults displayed lower blood pressures and were more compliant
with prescribed medication. Additionally, they observed a racial difference. The authors
found that although black religious males had higher blood pressures than white religious
males, they were more compliant with medication use for blood pressure control.
Recent research has examined spirituality and functional ability during
rehabilitation. Kim, Heinemann, Bode, Sliwa, & King (2000) examined spirituality using
an intrinsic Judeo-Christian scale of well-being and functional variables among patients
in a rehabilitation hospital. Intrinsic religiousness is defined as the individual's
internalizing a religious belief and living the belief. Individual spirituality scores though
high were not associated with variables of functional recovery such as mobility, and self-
care. Fitchett, Rybarcyk, DeMarco, and Nicholas (1999) found similar results in
postoperative rehabilitation. There was a high degree of spirituality among their patients
who rated their health as poor or very poor. Using a questionnaire that measures church
affiliation, attendance, and spiritual behaviors, the authors were unable to confirm a
relationship between self-health assessment, spirituality, and church activities. Pressman,
Lyons, Larson, and Strain (1990) in a small study of postoperative female orthopedic
patients found significant correlation between church attendance, personal importance of
religion, degree of spirituality, and functional meters walked (r=0.45, df = 27, p<0.05).
This research found that postoperative orthopedic subjects with strong religious beliefs
and practices, and less depression had better ambulatory function at discharge. The
spirituality score was not significantly correlated with ambulatory status independent of
depression. The authors suggest that subjects who are spiritual respond more favorably
to physical therapy because they are less depressed. Hodges, Humphreys, and Eck
(2002) investigated the effects of spirituality on spinal surgery recovery. Using a
spirituality tool that evaluates intrinsic spirituality, they found these subjects to be highly
spiritual (79%). The authors then compared preoperative and postoperative pain scores
with postoperative functional ability. They found no correlation between a high degree
of spirituality and pain scores or functional outcomes.
Spiritual research has investigated the possible relationships of pain, health and
functional recovery. In each study, older adults have a high degree of spirituality on
various measurement tools, but only one study reported a significant correlation that
included a finding of less depression. The investigation of spirituality and health has not
been evaluated using consistent measures of spirituality scales and postoperative
population groups. Most current research has observed possible religious affiliation,
spiritual beliefs and functional status.
Relationships between Spiritual Beliefs, Gender and Race
Few empirical studies have examined pain, gender, and racial relationships
(Affleck, et al. 1999). Research regarding utilization of health services demonstrated a
positive correlation between utilization and religious attendance in elderly male patients
60+ years of age. Increased attendance at religious services prior to hospitalization
correlated with a shorter hospital stay and fewer hospital admissions (Koenig & Larson,
Past research concentrated on religious coping behaviors, including religious
affiliation, beliefs and involvement. Research findings suggest that many older adults use
spiritual coping in various stressful health situations and that this coping has had a
beneficial effect. Further investigation is needed using spiritual measures to examine if
there is a spiritual coping adaptive effect in the management of older adult postoperative
Roy Adaptation Model-Based Research
In 1976, Sister Callista Roy's theory of an adaptation model for nursing was
presented to guide nursing education in the United States. The theory was later revised to
address the middle range or practice level theory relevant to patient care in nursing. In
1999, a new model of the Human Adaptive system was introduced to clarify the
understanding of the various components of the theory and to extend it into clinical
practice (Roy & Andrews, 1999). Roy defines the purpose of nursing practice as the
promotion of the ability of human adaptive systems to adjust effectively to changes in the
environment and to the individual's ability to modify their environment (Roy &
Andrews, 1999). Roy's theory contains scientific and philosophical assumptions that
describe successful human coping in changing environments. According to Roy, the
adaptation of the human system is based on scientific assumptions that include: 1)
meaning is necessary for person and environment integration; 2) thinking and feeling is
necessary for awareness; 3) people have a commonality of patterns and relationships; 4)
adaptation results from the integration people and their environment. Further, the
adaptation concept includes Roy's philosophical assumptions: 1) relationships include a
higher power and the world; 2) people use the ability of faith; 3) God is observed in
diversity of creation, and is the destiny of creation.
MODEL DIAGRAM OF RESEARCH QUESTIONS USING ADAPTATION MODEL
(ONTF..TTI Al. FOC L. COMPENSATORY ADAPTIVE
STIMULI STIMULUS LIFE PRO(_ ESiar MOUDES
DECREE OFIN PI
/E / I _SPIRITUALITY
RACE / ARTHaOPLASTY
Figure 2-1. Model Diagram of Research Questions
II I_ EALT H MEDICAW-nO USE *-
Figure 2-1. Model Diagram of Research Questions
Roy Adaptation Model Gerontologic Research
Roy describes the adaptive process as adjusting effectively to environmental
changes using cognitive interpretation and coping processes to maintain an integrated
life. In this model, compensatory life processes are spiritual coping and health self-
assessment. These regulatory processes provide an adaptive response for less pain.
Roy's adaptation model has been used mainly with children and adults in a hospital
environment. One gerontologic study has used the Roy adaptation model to evaluate a
coping process and the concept of self-consistency. Roy believes the concept of personal
self is a combination of self-consistency, the moral-ethical spiritual self and the self-ideal
(Roy & Andrews, 1999). Zhan (2000) used the Roy Adaptation Model to study
adaptation and coping with severe hearing loss in 130 elderly adults. Health status and
coping data were analyzed for positive relationships between cognitive coping and self-
consistency. There was a positive correlation between those who rated their health as
good or excellent and self-consistency. The variance in self-consistency was the result of
cognitive coping processes. Three cognitive processes; clear focus and method, knowing
awareness, and self-perception were most significant (36.97 (p< .001, df =5).
There is support for the use of the Roy Adaptation Model in gerontological
research to evaluate spiritual coping and adaptation to pain. Successful adaptation to
environmental changes is necessary to return to good health and well being as people age.
Chronic pain in the aged adult is both a physical and emotional experience.
Current research suggests that the use of pharmocologic and non-pharmocologic methods
in the elderly may reduce chronic pain. However, some research findings suggest that the
use of specific non-pharmocologic interventions such as spiritual behavior, religious
attendance, and spiritual beliefs are inconclusive in providing relief from the negative
effects of chronic illness and pain. This research study will evaluate relationships
between spirituality and analgesic medication use after total joint arthroplasty in older
Measurement of the degree of spirituality and health will evaluate the effectiveness
of coping with postoperative pain in the older adult. This research will provide
quantitative data to provide a framework for evaluating older adult's spirituality as an
alternative non-pharmocologic intervention in postoperative pain management.
This research examines the relationship of older adults' spiritual beliefs, and self-
health assessment and analgesic medication use during the first three days after total joint
replacement surgery. A correlational convenience design was used to investigate the
questions in a sample of surgical candidates scheduled for hip and knee joint arthroplasty.
Using the Roy Adaptation Model, this study examined relationships between total joint
arthroplasty for osteoarthritis, chronic pain, the degree of spiritual beliefs, spiritual
involvement, self-health assessment and the health outcome of postoperative analgesic
medication use. Participants for this research came from a socially diverse area in North
Three orthopedic surgeons from the University of Florida College of Medicine,
Department of Orthopedics performed all of the total joint arthroplasty. To control
variations in general anesthesia technique, one supervising anesthesiologist planned each
participant's anesthetic care. Participants chose his/her preferred method of
postoperative pain control prior to surgery. Choices included regional anesthesia, Patient
Control Analgesia (PCA), or PRN dosing. Preoperative patient education and anesthesia
evaluation was done according to the standard of care established by the University of
Florida College of Medicine.
1. 55 years of age or older
2. Primary hip or knee joint arthroplasty
3. Osteoarthritis of the hip or knee joint as demonstrated by radiographic exam and
orthopedic surgeon's diagnosis as documented in the medical record
4. Failed medical management of chronic joint pain
5. Inclusion regardless of comorbidity status
6. Candidates for hip or knee arthroplasty
Power Analysis and Sample Size
An estimate of statistical power was determined using the G power computer
software to calculate the required sample size. A total of 115 participants were consented
and completed the study. The sample size was based on a formulation of 80% power, at
least six independent variables, an effect size of 0.15 (R-squared= 0.13) with a
significance of 0.05 for a two-tailed test. The G power computer software was used to
calculate the required sample size (Erdfelder, Faul, & Buchner, 1996).
The Principle investigator of this study contacted the chairman of the Orthopedic
Department and presented a description of the study. The chairman then provided a
signed letter of agreement acknowledging awareness of this study (See Appendix A).
In the original protocol, I planned control variation in surgical technique using only
patients scheduled with one orthopedic surgeon. A total of 27 patients were enrolled
from July, 2003 until January, 2004. During this enrollment period, however, the
identified surgeon reduced the number of total joint surgeries he performed per month in
order to fulfill administrative duties. In January, 2004, the investigator met with
committee members to explore adding two additional surgeons in order to attain within a
reasonable length of time a number of subjects months adequate for a power analysis.
After appropriated discussions, two additional orthopedic surgeons agreed to help. They
were each provided a copy of the protocol and informed consent. A revision that
included the two additional orthopedic surgeons was submitted and approved by the IRB
in January, 2004.
Protection of Human Subjects
University of Florida Institutional Review Board (IRB) approval was obtained prior
to participant enrollment or data collection (See Appendix B for final approval, revised
approval and extension approval forms). A revision to include the additional orthopedic
surgeons was submitted and approved in January, 2004. A final IRB extension was
submitted June, 2004 to extend the research study from July, 2004 until July, 2005.
Patients scheduled for surgery are scheduled in the pre-surgical center for an
examination by an ARNP to determine their suitability for anesthesia. From this group
the principal investigator identified potential subjects for study. Subjects who met the
inclusion criteria and agreed to participate in the study were given a verbal description of
the study, confidentiality assurance, and possible risks of their participation. Those
patients who expressed willingness to participate completed two questionnaires. The
questionnaires took approximately 20 minutes to complete during their pre-operative
visit. The principal investigator and each subject signed a copy of the informed consent.
A copy of the signed informed consent was given to the participant for their individual
records. The principal investigator verbally asked each subject if they had additional
questions regarding their participation in this research study prior to their discharge from
the pre-surgical center.
A key containing the participant's name, and confidential code was developed.
Informed consents and questionnaires were coded with the participant's confidential code
and are kept in a locked file cabinet in the principal investigator's office.
Demographic data. Age, gender and ethnicity were coded using a coding key
(see Appendix G). Demographic data was entered on an Excel spreadsheet after
enrollment. There was no missing demographic data.
Preoperative Questionnaire Measures
Indicator of spirituality
The Spiritual Involvement and Belief Scale- (Revised (SIBS-R) Hatch, Burg,
Naberhaus, & Hellmich (1998) evaluates a broad range of intrinsic spiritual content from
ability to find meaning in life to spiritual writings. Designed for use with individuals of
all religious and non-religious traditions that include Christian, Judeo, Hindu, Islam and
Atheist. This instrument differs from other spiritual measurement tools in that it is not
limited to individuals with a Judeo-Christian tradition.
For the purpose of this study one question was selected to evaluate participants'
spirituality. Two groups were created using the response to the question, "How spiritual
a person do you consider yourself?" Subjects were asked to rate themselves on a scale of
1 to 7 with 7 meaning "the most spiritual". Those groups who rated themselves 5, 6, or 7
were considered highly spiritual and coded as 1. Those who rated their spirituality as
1,2,3, or 4 were considered less spiritual and coded as 0
Indicator of self-health assessment
The Rand SF-36 Health Status Questionnaire measures physical functioning, social
functioning, role functioning (physical problems) and role functioning (emotional
problems). Additionally, the instrument measures mental health, fatigue, pain, and
One question, "In general would you say your health is", was used to create two
groups for the analysis. If a participant answered good, very good or excellent, their
response was considered as a high self-health assessment and coded as 1. If their
response was fair or poor, their self-health assessment was considered a low score and
coded as 0
Questionnaire data. Using the patient's confidential code all questionnaire data
was entered using an excel spreadsheet. Missing data on questionnaires was entered as a
Indicator of diagnosed osteoarthritis. A diagnosis of osteoarthritis was recorded by
the orthopedic surgeon and is available in each individual participant's medical record.
The diagnosis was verified with the individual's pre-surgical history and physical
Indicator of ethnicity
Ethnicity was obtained from the patient's admission record. The admissions
department routinely obtains ethnicity information during a patient's initial interview
prior to entering the hospital.
Postoperative Data Collection Procedures
Indicator of pain scores. Individual postoperative pain scores were obtained from
the individual's medical record. Daily pain scores were recorded and averaged for three
days postoperatively. Additionally, a daily median pain score was recorded for this same
interval. Pain was evaluated using the Visual Analog Scale (VAS) that evaluates pain
intensity numerically using a 0 to 10 measurement (0= no pain, 10= worst pain). The
VAS instrument is used with all age groups and is the approved pain scale for use at
Shands Hospital at the University of Florida.
Analgesic medication use. Medications dispensed during a patient's hospitalization
are records in the Medication Administration Record (MARS). The MARS documents
each dose of medicine administered by nursing personnel. This medication record
contains the medication name, date, time, dosage and initials of hospital personnel
administering the medication. Individual Medication Administration Records (MARS)
were evaluated for the use of narcotic analgesic medication for every participant. An
Opioid equi-analgesic conversion table was used and all opiates were standardized to
morphine sulfate equivalents. For example, 1.5 mg IV Hydromorphone = 100 mcg
IV/SC Fentanyl = 20 mg P.O. Oxycodone = 10 mg IV Morphine (Pasero, Portenoy &
McCaffery, 1999). Total IV Morphine Sulfate equi-analgesic conversion was recorded
for each postoperative day for three days.
Regional anesthesia use. Regional anesthesia techniques such as epidural, Femoral
Nerve Sheath Catheters, and Psoais Compartment Catheters provide postoperative pain
relief by blocking nerve conduction with local anesthetics, thereby blocking the
transmission of pain (Pasero, Portenoy, & McCaffery, 1999). The use of a local
anesthestic provides a sensory and motor blockage. The epidural regional anesthesia
technique occasionally requires the use of an opioid agent in addition to a blocking agent.
The use of an opioid agent is recorded on a separate analgesic document in the patient's
medical record. The placement location of regional anesthesia is recorded on a separate
document located within the patient's medical record.
Medical record data. Medical record data collected included surgical site,
anesthesia data, pain scores and analgesic medication used. A form was developed (see
appendix) to collect data from the participant's medical record after discharge. Medical
records were requested using a Request for Records review and Shands at the UF
Research Chart Request forms. An average of 4-20 charts were requested each time;
medical records usually required two weeks to be assembled. Several delays were
experienced in obtaining medical records that included research medical records
personnel vacation days, sick days, and incomplete delivery of records. One medical
record has been lost. Two records are incomplete with medication records missing.
The Medical Record Department requires that all data and chart review must be
preformed in the records department. Using the coding key, data was recorded on the
case coding form. Pain scores were documented as average scores and median pain
scores. All opioid medications were converted to Morphine Sulfate IV equi-analgesics
and recorded. Surgical site, anesthesia type, regional anesthesia, general anesthesia were
coded using the coding key.
Data obtained in the postoperative period were entered on an Excel spreadsheet.
Analysis used SPSS statistical software, Version 11 for Windows. Demographic data for
spirituality, self-health assessment, age, gender, pain scores, and analgesic medication
use were analyzed to generate descriptive statistics using mean scores and frequencies
The hypotheses were tested with analysis procedures using Pearson's correlation
coefficient, T-Test and ANOVA with significance levels of 0.05. Correlations measure
how variables are related and measure their linear association. Frequencies and mean
scores were analyzed for all demographic data, age, gender, operative site, physician,
regional anesthesia and analgesic medication use. Individual survey questionnaire items
were analyzed using frequency and percentage of individual participant response.
This chapter presented research design, sample inclusion, power analysis,
methodology, and data collection procedures for this study. Data analysis methodology
for research hypotheses was discussed.
A description of the participants and the results of this descriptive study are
presented in this chapter. The results are examined in relation to the three hypotheses.
This study took place at Shands at the University of Florida. Subjects were recruited as a
convenience sample that included only persons that met the inclusion criteria. Informed
Consent and questionnaire data were collected in the pre-surgical anesthesia clinic.
Demographic data, pain scores and medication use were obtained from the subject's
medical record after hospital discharge. All data was computed using the SPSS statistical
software, version 11 for Windows. Statistical significance was set at p < 0.05.
A total of 126 potential subjects who met the inclusion criteria were approached to
participate in the study. Eleven potential participants declined to participate. Three
stated they were "tired of filling out paperwork", two did not want to participate in any
research and one did not believe in spirituality. Five did not express a reason for refusing
participation. None of the potential research participants expressed any fear of an
adverse event by participating in this study. All subjects who agreed to participate signed
an informed consent and completed the two questionnaires in the pre-operative anesthesia
center. At the end of the study one subject's medical record was missing from the
Medical Records Department and after a detailed search was considered lost. One
subject's Medication Administration Record was missing from the medical record and
presumed lost. All other participants' medical records were complete at the end of the
data collection period.
One hundred and fifteen subjects who met the inclusion criteria were consented.
The mean age of the sample was 67.70 (SD = 8.23). Seventy- four (64.3 %) of the
participants were female and 41 (35.7%) were males. The majority of the participants
were Caucasian (n = 111), followed by Hispanic (n = 2) and African American (n = 1).
All participants were diagnosed with severe osteoarthritis and had failed
conservative medical management. Right total knee arthroplasty was the joint
replacement most frequently performed at 35% (n = 35), followed by left total knee
arthroplasty at 27.8% (n = 32), right total hip arthroplasty 18% (n=18), left total hip
arthroplasty at 13.9% (n =16), and bilateral total knee arthroplasty at 10.4% (n = 12).
Forty-six percent (n = 56) of the participants chose a femoral nerve sheath for post-
operative pain control, while 25.2% (n = 29) chose an epidural, 3.5% (n = 4) chose a
psoas compartment sheath, and 1.7% chose a continuous spinal. Patient controlled
analgesia (PCA) was used by 67% (n = 77) of subjects. The PCA group includes some of
the subjects who received a femoral nerve sheath. All other participants selected "as
needed" analgesia for postoperative pain control.
Anesthesia Technique During Surgery
General anesthesia was administered to 100 participants (87%) followed by
continuous spinal at 4.3% (n = 5), followed by managed anesthesia care at 2.6% (n=3).
Analysis of Data in Relation to the Hypotheses
Hypothesis 1 stated that older adults with a high degree of spirituality receiving hip
or knee arthroplasty for primary osteoarthritis would report less pain and receive less
analgesic medication than those participants with a lower degree of spirituality after
controlling for health self-assessment.
The Pearson Correlational analysis as shown in Table 3, demonstrated there was no
significant correlation between spirituality response, self-health questionnaire response
and the following variables: age (r = -0.02, p = 0.84), average pain scores day one (r=
0.01, p = 0.92), average pain scores day two (r = 0.02, p = 0.84), average pain scores day
three (r = 0.03, p = 0.78) and analgesic medication use (r = -0.04, p = 0.69). A partial
correlation coefficient controlling for the self-health assessment score was then analyzed
(See Table 4) and there were no significant correlations between spirituality, and the
variables: age (r = -0.05, p = 0.60), pain day one (r = 0.53, p = 0.59), pain day two (r =
0.06, p = 0.53), pain day three (r = 0.06, p = 0.56) and pain medication (r = -0.02, p =
0.81). Hence, Hypothesis 1 was rejected.
Hypothesis 2 stated that older adults with a high score on the high self-health
assessment tool would report less pain and receive less analgesic medication than those
participants with a low score on the self-health assessment tool after controlling for
The Pearson Correlation found there was a significant correlation as shown in
Table 5 between the variable for health on the Short Form-36 Health Survey and age (r =
0.23, p = 0.02), average pain scores day one (r = -0.31, p = 0.00), day two (r= -0.29, p =
0.00) and day three (r = -0.22, p = 0.03). There were similar results for days one, two,
and three and median pain scores. However, there was no significant correlation between
the variables, analgesic medication use (r = -0.11, p = 0.23) or high spirituality (r = 0.13,
p = 0.17) as shown in Table 5.
A Pearson Partial correlation for health assessment while controlling for spirituality
was analyzed. There was a statistically significant correlation for the following variables:
age (r = 0.23, p = 0.02), pain scores on day one (r = -0.31, p = 0.00), day two (r = 0.29,
p = 0.00), day three (r = -0.22, p = 0.02). There was no significance for less analgesic
medication use (r = -0.11, p = 0.26) as shown in Table 6. The results confirmed
Hypothesis 2 for pain, but rejected it for analgesic medication use.
Hypothesis 3 stated that there would be less analgesic medication used in those
older adults receiving hip or knee arthroplasty who had a high degree of spirituality
involvement and beliefs and a high score on the self-health assessment tool.
An ANOVA regression was used to determine if there was an interaction between
good to excellent health and a high degree of spirituality. The relationship was not
significant (F = 1.04, p = 0.38). Further analysis a T-Test was used to determine if there
was a difference in the average analgesic medication use between the high spirituality
group and the good to excellent self-assessed health group (Ms = 7.63 and 8.49
respectively). Hypothesis 3 was rejected.
For the purpose of this research, one question rating degree of spirituality was used
from this scale. The SIBS tool was satisfactory and demonstrated a Cronbach Coefficient
Alpha 0.94 Raw Score. Each participant completed the 39-item questionnaire and there
were a many positive responses to specific questions on the spirituality and beliefs scale.
For example, on the item "spiritual health contributes to physical health," 70.4% agreed
or strongly agreed. Most participants considered themselves spiritual when asked to rate
their spirituality on a scale of 1 to 7 (with "7" being the most spiritual). Participants used
religious coping such as hope, personal relationship with a greater power than self, and a
belief that prayer changes things. A high number of participants (77%) wanted others to
pray for them during their illness. More than 70% of the respondents felt that spiritual
health contributes to physical health. Additionally, 95 or 82.6% of the participants
always or almost always make an effort to apologize when they do wrong to someone.
Overall scores on the SIBS instrument reflected a positive relationship with a higher
power, prayer, a belief in an after life, and continued spiritual growth (see Table 7).
Participants expressed difficulty with the SIBS questionnaire and often said, "this is
too hard to answer" or, I have to think a lot". However, no participant asked for
clarification of a SIBS question.
The Short Form-36 Health Survey
For the purposes of this research participant response to the question "In general
would you say your health is: excellent, very good, good, fair, poor" was used for
analysis. Participants answered the 11-item self-assessment tool that queried physical
and emotional function. It is of interest that most were "limited a lot" for vigorous and
moderate activities. Daily activities such as walking, bending, kneeling and stooping had
the highest response for "limited a lot". Simple activities such as dressing and bathing
were least limited. The tool seemed easier than the SIBS for participants to complete and
there were no missed questions.
Table 1. Frequency and Percent of Variables
Variable Frequency Percentage
Male 41 35.7
Female 74 64.3
White 111 96.5
African American 1 .9
Hispanic 2 1.8
No response 2 1.7
Left Total Hip Arthroplasty 16 13.9
Right Total Hip Arthroplasty 18 15.7
Left Total Knee Arthroplasty 32 27.8
Right Total Knee Arthroplasty 35 30.4
Bilateral Total Knee Arthroplasty 12 10.4
Surgeon #1 81 70.4
Surgeon #2 23 20.0
Surgeon #3 11 9.6
No Regional 22 19.1
No Response 1 .9
Epidural 29 25.2
Femoral Nerve Sheath 56 48.7
Psoas Compartment Sheath 4 3.5
Continuous Spinal 2 1.7
Spinal 1 .9
Patient Controlled Analgesia
No Response 3 2.6
NoPCA 35 30.4
PCA 77 67.0
No Response 2 1.7
GETA 100 87.0
Spinal 5 4.3
MAC 3 2.6
Continuous Spinal 5 4.3
Table 2. Summary Measures of Variables
Scores day 1
Scores day 2
Scores day 3
Scores day 1
Scores day 2
Scores day 3
Table 3. Pearson Correlation Coefficients-Spirituality and Variables with No
Variables r value p value n
Age -0.02 0.84 111
Pain Day 1 (average) 0.01 0.92 109
Pain Day 2 (average) 0.02 0.84 108
Pain Day 3 (average) 0.03 0.78 103
Pain Day 1 (median) 0.01 0.91 109
Pain Day 2 (median) -0.03 0.75 108
Pain Day 3 (median) 0.10 0.30 102
Analgesic Medication Use Day 1-3 -0.04 0.69 109
Table 4. Pearson Partial Coefficients-Controlling for Health Assessment
Pain Day 1 (average)
Pain Day 2 (average)
Pain Day 3 (average)
Pain Day 1 (median)
Pain Day 2 (median)
Pain Day 3 (median)
Analgesic Medication Use Day 1-3
Table 5. Pearson Correlation Coefficients-Health Self-Assessment and
Pain Day 1 (average)
Pain Day 2 (average)
Pain Day 3 (average)
Pain Day 1 (median)
Pain Day 2 (median)
Pain Day 3 (median)
Analgesic Medication Use Day 1-3
Table 6. Pearson Partial Coefficients-Health Self-Assessment and Variables Controlling
Variables r value p value n
Age 0.23 0.02 108
Pain Day 1 (average) -0.31 0.00 106
Pain Day 2 (average) -0.29 0.00 105
Pain Day 3 (average) -0.22 0.02 100
Pain Day 1 (median) -0.26 0.01 106
Pain Day 2 (median) -0.30 0.00 105
Pain Day 3 (median) -0.22 0.03 99
Analgesic Medication Use Day 1-3 -0.11 0.26 106
Table 7. Frequencies and Percentages for Self- Reported SIBS Questionnaire (N=115).
Answers reflect Agree or Strongly Agree scores only Frequency Percentage
except for questions that are reverse score negatively
worded items. These items were scored disagree or
(1) I set aside time for meditation and/or self- 51 44.3
(2) I can find meaning in times of hardship. 67 58.3
(3) A person can be fulfilled without pursuing active 43 37.4
spiritual life. (disagree/strongly disagree)
(4) I find serenity by accepting things as they are. 53 45.0
(5) Some experiences can be understood only through 64 55.6
one's spiritual beliefs
(6) I do not believe in an afterlife. 70 60.9
(7) A spiritual force influences the events in my life. 70 60.9
(8) I have a relationship with someone I can turn to 69 60
for spiritual guidance.
(9) Prayers do not really change what happens. 79 68.7
(10) Participating in spiritual activities helps me 70 60.9
forgive other people.
(11) I find inner peace when I am in harmony with 68 59.2
(12) Everything happens for a greater purpose 70 60.9
(13) I use contemplation to get in touch with my true 43 37.4
(14) My spiritual life fulfills me in ways that material 62 53.9
possessions do not. (This question is missed by 25
or 21.7% do to its position in the questionnaire)
(15) I rarely feel connected to something greater than 62 53.9
myself. (disagree/strongly disagree)
(16) In times of despair, I can find little reason to hope. 80 69.6
(17) When I am sick, I would like others to pray for 89 77.4
Table 7. Continued
Answers reflect Agree or Strongly Agree scores only Frequency Percentage
except for questions that are reverse score negatively
worded items. These items were scored disagree or
(18) I have a personal relationship with a power greater 81 70.4
(19) I have had a spiritual experience that greatly 57 49.6
changed my life
(20) When I help others, I expect nothing in return. 98 84.2
(21) I don't take time to appreciate nature. 70 60.9
(22) I depend on a higher power. 70 60.9
(23) I have joy in my life because of my spirituality 74 64.3
(24) My relationship with a higher power helps me 69 60.0
love others more completely.
(25) Spiritual writings enrich my life. 61 52.1
(26) I have experienced healing after prayer. 47 40.9
(27) My spiritual understanding continues to grow. 74 64.3
(28) I am right more often than most people. 34 28.0
(29) Many spiritual approaches have little value. 62 53.9
(30) Spiritual health contributes to physical health. 81 70.4
(31) I regularly interact with others for spiritual 52 45.2
(32) I focus on what needs to be changed in me, not 75 65.2
what needs to be changed in others.
(33) In difficult times, I am still grateful. 91 79.1
(34) I have through a time of great suffering that led to 51 44.3
The following questions were scored using only the response always or almost always
(35) When I wrong someone, I make an effort to 95 82.6
(36) I accept others as they are. 75 65.2
(37) I solve my problems without using spiritual 25 21.7
Table 7. Continued.
Answers reflect Agree or Strongly Agree scores only Frequency Percentage
except for questions that are reverse score negatively
worded items. These items were scored disagree or
The following questions were scored using only the response always or almost always
(38) I examine my actions to see if they reflect my 49 42.6
The following question was scored 1-7 with "7" being the most spiritual. Scoring for this
question used response 5,6,7.
(39) How spiritual a person do you consider yourself? 50 66.9
Table 8. Frequencies and Percentages Questions that Indicated Ratings for General
Health, and Bodily Pain as Self-reported on the Short Form-36 Health Survey
Questions Frequency Percentage
(1) In general would you say your health is: 94 81.73
response: excellent, very good, good
(2) Compared to one year ago how would you rate
your health in general now?
Much better 9 7.83
Somewhat better 18 15.65
About the same 61 53.04
Somewhat worse now 23 20.00
Much worse now 4 3.48
(7) How much bodily pain have you had during
the past 4 weeks?
No response 2 1.74
None 0 0
Very Mild 14 12.17
Moderate 36 31.30
Severe 46 40.00
Very Severe 17 14.78
Additional findings included the increased use of regional analgesic techniques
during the last six months of this research. Concurrent research by another investigator
enrolled some of these same participants receiving total knee arthroplasty in a study using
femoral nerve sheath technique to treat postoperative pain. This investigator examined
the pain report outcomes for two of the most frequently used regional analgesia methods
of postoperative pain control: epidurals and femoral nerve sheath catheters. Analysis of
these two methods compared the mean pain scores on postoperative days one, two and
three. Both techniques had lower mean scores for pain scores on days one, two and three
when compared to no regional technique. The epidural provided the lowest mean score
day one (M= 2.74) compared to the femoral nerve sheath on day one (M= 3.17). Those
participants using PRN analgesia and no regional technique had the highest mean pain
score on day one (M=4.25). On day two, the femoral nerve sheath provided the lowest
mean pain score (M==1.82). On day three all of the regional analgesia had been
removed, but the mean pain scores for those persons who received regional analgesia
remained similar to days one and two. On all three days the PRN analgesia group had the
highest mean pain score (Ms= 4.25, 2.90, and 2.94, respectively).
In summary, these findings demonstrated that participants in this study were in
moderate to severe pain and had functional limitations preoperatively, but described
themselves as in good to excellent health and very spiritual. The use of regional
analgesia for postoperative pain control did lower pain scores for all days when compared
to those who did not receive a regional technique.
The purpose of this study was to examine the relationships between the degree of
spirituality and high scores on a self-health assessment questionnaire with three
postoperative outcomes after hip or knee joint arthroplasty. Specifically, this study
examined the relationships between a high degree of spirituality, a high score for
individual self-health assessment and pain report and analgesic medication use for three
days after total joint replacement surgery. The hypothesized relational statements were
based on the need for quantitative data collection measuring the relationships between
spirituality, health assessment, pain report and analgesic medication use. There is no
previous empirical research that has examined these relationships in the postoperative
arthroplasty patient. The study sample consisted of 115 participants scheduled for hip or
knee arthroplasty in a large Southeastern teaching hospital. This chapter will present a
discussion of (1) research findings, (2) conclusions, (3) research strengths and
weaknesses, and (4) implications for nursing practice.
This section will discuss sample characteristics, followed by study of findings as
they related to the research questions.
One hundred and fifteen older adults who were scheduled for hip or knee total joint
arthroscopy consented to participate in this study. All of the participants were recruited
from the pre-surgical anesthesia center of a large teaching hospital. In this convenience
sample, the participant ages ranged from 55 to 86. The average age was 67.70. There
were 41 males and 74 females enrolled in this study. This finding is somewhat less than
the 2:1 ratio females to males in osteoarthritis prevalence as reported by other researchers
(Davis, Ellinger, Newhaus, & Hauck, 1987). Participants described their generalized
body pain as severe or very severe (55%) during the four weeks prior to their scheduled
surgery, but self-assessed their health as excellent, very good or good (81.73%).
Anderson, et al. (1993) and Mobily, et al. (1994) reported similar pain report among older
adults. This research found that functional abilities were severely limited for vigorous
activity such as participating in strenuous sports, lifting heavy objects, vacuuming,
playing golf walking several blocks, bending, stooping and climbing stairs while more
moderate activities such as lifting groceries, bathing and dressing were "limited a little".
Praemer, Furner, & Rice, (1992) and Salmon, et al. (2001) found similar functional
limitations in osteoarthritis patients.
Ethnicity could not be examined due to the low numbers of African Americans and
Hispanics enrolled in this research. Felson (1988) similarly found that greater numbers
of European whites have osteoarthritis than other ethnicities and this may account for the
differences observed in this study. Only one African American and two Hispanics were
enrolled in this research. Socioeconomic status may have been a factor in the low
number of other ethnic groups seeking joint replacement. However, socioeconomic
status was not considered in this research.
Spirituality, Pain Report and Analgesic Medication.
The first research question examined the relationship of a high degree of
spirituality, postoperative pain scores and analgesic medication use. One research
question was used from the SIBS questionnaire. Two groups of participants were created
using one research question from the SIBS questionnaire. Those with high scores for
spirituality were considered highly spiritual. The majority (69.4%) of the respondents
were highly spiritual. A partial correlational analysis was used to identify a relationship
between a participants' high spirituality and the variables, age, pain report for three days
and analgesic medication use postoperatively, controlling for self-assessed health. There
was no relationship for spirituality and the variables. Therefore, hypothesis 1 was
rejected. Participants who have a high degree of spirituality did not tend to have less pain
and did not tend to use less analgesic medication postoperatively. Although there was a
high participant response to spirituality, the possibility of spiritual coping did not tend to
influence pain or pain medicine use after joint replacement surgery.
Health Self-Assessment, Pain Report and Analgesic Medication Use
It was hypothesized that participants who consider themselves healthy will report
less pain and use less analgesic medication postoperatively. The health variable "In
general would you say your health is: excellent, very good, good" was used to identify
those participants with a high score on health assessment. Of the participants, 81.7%
rated their health in this positive way. Correlation analysis found that persons who
considered themselves healthy tended to have less pain on each day postoperatively but
they did not tend to use less pain medication. Therefore, there was no association
between high health scores and less pain medication use. Further analysis using a partial
correlation controlling for the spirituality variable, found similar results; a healthy
assessment was related to less pain for the three days postoperatively and had no
relationship with the amount of pain medication.
In summary, participants who rated self-health as good, very good or excellent
tended to experience less pain during the first three days postoperatively. However, these
same participants did not tend to use less pain medication. Research question 2 was
accepted for less pain, but rejected for less pain medication use.
Impact of Health Assessment and Spirituality on Pain Reports and Analgesic Medication
Lastly, it was hypothesized that participants who considered themselves to be very
spiritual and healthy would use less analgesic medication during their postoperative
recovery. A regression analysis was used to determine possible interactions between
health assessment and spirituality and analgesic medication use. There was no
relationship between the variables and pain medication. A further T-Test was used to
determine if there was a difference between the high spirituality and the high self health
assessment groups in analgesic medication use. The T-Test found no mean difference
between the two groups.
Therefore, Hypothesis 3 was not accepted. Those participants who self-rated their
health as good, very good or excellent and considered their spirituality as high did not
tend to experience less pain or use less pain medication than did the other research
Although participants reported moderate to severe bodily pain and a decrease in
functional activity on a health questionnaire, they considered themselves to be healthy.
There was a relationship between self-health and pain for the first three days after
surgery. It demonstrated that how a person views their health contributes to the amount
of pain they experience after joint replacement. Additionally, less pain experienced did
not mean less pain medication used. There has been no previous research evaluating
relationships between how healthy an individual feels and the amount of pain medication
used after surgery. Previous research that has evaluated health status has been with
individuals who were in "poor health" with long-term disability after surgery.
Most participants considered themselves to be highly spiritual and used spiritual
coping methods such as hoping, praying and dependence on a higher power. There is no
previous research that has examined the spirituality and postoperative pain or pain
medication use afterjoint replacement surgery. Previous research that evaluated
spirituality, health assessment and functional recovery used a very different patient
population. The only similarity was a high degree of spirituality among the older adult
rehabilitation patients (Fitchett, et al. 1999; Kim, et al. 2000; Pressman, et al. 1990). In
my research, most reported that they used spiritual coping methods and behaviors such as
participation in spiritual activities, spiritual writings and prayer. They also believe their
spiritual health contributes to their physical health. The majority of the participants in
this research used these spiritual coping methods. However, there was no evidence that
high self-evaluation for spirituality influenced pain or pain medication use after total joint
Strengths and Limitations
Although this research had strengths, it was limited in its methodology. Primarily
it was a convenience sample of pre-operative total joint arthroscopy patients. This
research was impaired by the use of regional anesthesia by the majority of the
participants. These patients received more regional anesthesia techniques for pain control
postoperatively than most other surgical patients. Regional analgesia is an effective
technique in the treatment of post-operative arthroplasty pain. Pain report and
medication use for this group of patients were affected by the use of the regional
anesthesia techniques. It was not possible to control for the increase in regional analgesia
techniques during this investigation.
There was an uneven distribution of males and females. This was to be expected,
but did not approach the 2:1 ratio for osteoarthritis found in previous research. There was
no ethnic diversity found in this research and this finding does not represent the ethnic
distribution in the geographic region.
Implications for Nursing Practice and Future Study
There is evidence from this study that these patients requiring total joint
replacement for osteoarthritis have a high degree of spirituality and perceive their health
as good to excellent. They use spiritual coping and behaviors such as prayer, spiritual
activities, and belief that spiritual health influences physical health.
Second, they feel their health is good to excellent regardless of their functional
limitations or pain. This self-assessment of good health contributed to less pain after total
joint surgery, but did not lessen the need for pain medication.
It is important that the clinician recognize that the postoperative patient is
multidimensional in their self-health and their spirituality. This quantitative study did not
support the hypothesis that spirituality decreases pain or pain medication use. This
research did find a relationship between self-assessed good health and decreased pain, but
did not find a relationship in less pain medicine use. This research contributes to the body
of literature evaluating spirituality and health in the older adult.
Future research should include postoperative function and pain using longitudinal
data collection. Assessing joint arthroplasty subjects pre-operatively, one month
postoperatively and at the end of the one-year recovery period would provide long-term
data on the relationships between spirituality, self-health assessment, pain and physical
function. Correlating functional longitudinal data with spirituality and health assessment
would provide more pertinent information without interference from postoperative
The implications of this study for nursing practice are that the findings of this study
support the use of spirituality and spiritual behaviors by the majority of the participants.
Good to excellent self-health assessment did change the amount of pain these participants
reported after surgery. Nurses should be more at ease in assessing a patient's spirituality
and self-health. Nurses do have to recognize that how a patient evaluates self-health may
be important in reducing postoperative joint arthroplasty pain.
In summary, evaluating the participants' spirituality and self-health assessment
found interesting relationships between postoperative pain and analgesic medication use.
Second, these research findings have implications for further future nursing research.
LETTER OF AGREEMENT
1 UNIVERSITY OF
,tlcr.- oni Mdedrp,.
eputment of Drthopedics and Rehabilitation
July 25. 2003
R. Petr lafate, PharmiD.
Chairman IRB 01
PO Box 100246
ainewsil FL 326~04)24
Fa.. 352i 3r2-afb37
Re: Poject 259-2003 "EBfecs of Spiral Belies and Involvement and a Positive Self-Halth
sicssmnenl Lri PredLr;n POSt-Operati Analgesic Medicaion Use in Total oint
Arhroplasly in the Older Adult"
I am aware of Pau riia McNaily',s audy on Lh, eAliecu of spiriiWIa bdicfs and its relationship on
pr1-opje)[alc analgcic imTdicadtir in lotl joint arthroplasty. She and I have had multiple
convenwrsaions about the study and the implementation of iL
1 appreciate the work and diligence of your group
All rhc hWi,
Peter F. Gemren, M.D.
Associate I'roi'es~r and I[ntim Chairman
Dcpnirmnci ofOrhopaedics an] Rtehailliison
CC: Ms. LLrLId Kephan FI iln
Coordinmolr Rie~arUh Programs
INFORMED CONSENT 08-19-03 TO 07-15-04
Infonneconstl 0 Pakw re har kan k Sr
ond .whOraauetonfor Collecrion; Use, and
Disclosure of Protecled Heallh 14(onnfaton
University at fiorna
Instllional Review Board
APPROVED FOR USE
fea~8i9.m ffjt~fo -i~agi
You r being asked to take par in a research slid. This form provides you with Infomlion
about ite srud and sleks your auhonzation for the collkln, use and disclosure of your
proclead hcaltlih fomnnion necessay forthe study. Te Principal invewigaior (le pcrsn in
carge ofthis research) or a representatiw" offh Principal Investiglor v-il adLo dscnibe Ihis nsudy
to you tn ansHer aLi of your questions. BcfoI)ou decide whether or noi to tke pan, read ihe
information below and ask quesiorm about anything you do not undcstm d. Your participation is
1. Nime or P lartpnpal ("Sludy Subject")
2. Tilk of Rearch Study
Effects ofSpiritual Befeis and rnvolvenwy t end a Positive Self-Healh As5csmer t in
Predicing Posoperative Analgesic Medication Use in Total Jont Athroplasty n the Older
3. Principal lanvestgar and Tclkphone Numberis)
Patricia Anne McNalt
4. Somrce orFundlag or Other Material Spport
University of Firida
S. What l the purpose of thi research study?
You are being asked if you are itereed in parric~patiinn his tidy because )ou are
259-2003 07-10-03 / Page 1 of 7
scheduled fr joint repllacinent surgery. This study is being done to ser if thre is a
relationship between your spiritual belef h and your health evaluation and your nted fr pain
medicine. T11 purpose o ihis study is to measure the amount of ain medication you use for .
the first three days after )our surgery.
6. What wWl be done if ou take part l (hias research study?
You will be asked to participate in this sIudy after >ou haFe been scheduled with Dr. P.
Gearen for hip or knee replacenmnI surgery. Through your panicipalon -i this study you will
be asked to complex Iwo survey questionnaires. These survey queslionrA~res ul l dke
approxin~tely 20 minutes io complete. You do not lave to answer ahl ofth questions if you
do not want to answer lL The purp~bc orthis study is to explore reltionshps between
sprtual beliefs, spiritual involvcneni, a personal health evaluation and the amount of pain
indication use after joint replaemen surgery. Your medical record wil be eaminied for
three days after surgery to determine the amount orpain ou report nr surgery and the
amount of pain meication you use. Other info nm oron e'mincd froim your medical record
Aill include your age, sex, diagnosis, location orjorum replacerncni and anesthesia given 10
you during your surgery. The Prncrpal Investigalor will code Oil ofyour infor nnion wilh
confidential code numbers. All ofyour data will kep in a locked secure fie.
All of your care wa be normal procedures ihat arc part of he ireaL-erm for all patients
haT-irng otial joint replacernent surgery. There will be no differences in your treatment while
you are part ofthis study.
7. Whma ar e heposible discomforts and riss?
There will be no possible risks for you as a participant in this study. You may experience
discnmfort in aswering qulestons regarding .3ou spirilualil)
Throughoi the study, the researcher will norify yu of new infomaliaon that nay become
available that irna) aff et .or dJcsion 10 reniain in the sudy.
If you wish to discuss the information above or anr discomforts you nmay e,
ask queiorns nrow or call ihe Principal Inlrigator or co cun person listed on the front page of
sa, What are the possible baenelts to you?
There are no benefits to you as part of hi study.
8b.What are the possible benefits to others?
If this lsudy should show a relationship between spiritual b]ie l spiritual participation
person health evaluation and pain medication use, other studies may be done to develop
alternaiWve ways to treat patients in the future.
-;9.-03 / 07-10-03/ Page 2 of 7
9. If you oose to take part in this retarch study, will It ct you anything?
Thre wig be no change to you for being part of this study.
10. Willyou receive tompenIallin for asking prt in this reserch study?
You will not be paid for taking par in ths study.
11. What If you are Injured because of Ihbe b hl.?
[rfou cip.cricen an injury that is dircy caused by this slidy. only professional consulllive
care thai you receive at the University of Florida Health Science Center will be provided
without charge. However, bespiial cxpensi will have to be paid by you or .!Fw i,-ksurancw
provider. No other compensation is offered.
12. What olher options or treatments are atailjble if yu do not want lo be in this sudy?
You ar free 10 choose no to take pa in this study. Ifyou chose not to take part n this
study. your joint replacement surgery will continue and you wil receive the same level of
care. f you do not want to take part in this study, tell the Principal Investigaor or her
assistant and do not sign is Ii nforned Conseni Form.
13a. Can you wilhdraw from this reuear study?
You am free to willdraw your consent and to slop partkipalr' in his research study at any
time. If you do withdraw your consent, there w~II be no prally, and you will not lose any
benefits you are nlitled to.
f you decide to withdraw your consent to panricpaie -i il research sudy for any rJson, you
should contact Patricia Anne icNalty n (3 5 ) 2!1-7452.
Ifyou Iha e any questions regarding iour right s a rescich submi. you may phone the
Institutional Review Boad (IRD) oflte at (352) 846-1494.
13b. If you witlhdrw, can inlormatloa about you still be used sad/or collected?
f you withdraw fronm the study. the principal inveslator would like to mrninue io keep end
use bhe infonnation that you conpleed using the questionnairs, pain scores, pain medicine
and other information obtaied from your medical record If ou refuse to le the Principal
Invesigator continue to keep and use this information, it will not be used.
259-2003 07-0-D3 Page 3 of 7
13c. Can Ihe Principal investigator nihdraw you from hbis research stud)?
You may be withdrawn firn the sLudy without your consent for the following reasons;
You did not quality to be in ait study because you do not meet the Sudy reqLirimnnts Ask
the PiLnipal Investijiiorr if you woltd like more information obos this.
14. How nlIyour privacy and the confidentitUl) of hour prorreld health informarion be
Data will be gearered and maintained using confidential codes io proltiu o'Lur identify. Patricia
McNally, the Principal Invstigator, will gather medical data obtained from your medical
cord. All data and inirmtion will be kept in a locked file in the office of Palrlci McNally,
the Principal Invcsigalor. Patricia McNally wi a.sgn aU confidenLal code numbers Access
to your file w be restricted to the principle investigator.
li)ou participale in ths research, your proiccied h dilh infonrm ion will be coUlcc.-d used, and
disclosed under the terms specified in seclio 15 23 b-low.
15, ItIou agree to pardcipate in Ibis rtwarch arudy, what prtected health nforl action
about you may be colleci d, used d disclosed to other?
To dvlennine your cligibly rb r Ihe study and as part of your participation in the study, your
protected health Infornn;ton that is obtained from you, from review cf your pst. curmiil or
Ifture health record~ from procedures such as physical examntions, xrys, blood or urine
tests or other procedures. forn your response to any study trealnm ts you receive, from your
study visit and phone calls and "a other sludy relitd hrthh inlbrmntion, may be collected,
used and disclosed to others. More specifically, the fllowig information may be collected,
used, and disclosed to others:
Complete past medical history to determine rig iihi y criteria listed in informed consent
Quest ;onnires that you have comptl8ed
Medical records about yourjoinl replacement surgery
Medical records about pain nmdiialion us after surgery
Medical records about pain reported
Mkedial reords about ancsiF ia used during surgery
16, For whal srudl-relled purposes sill )our p roecled health lnformati a he coll0Eed, used
and dbclosed to others?
'atrr protlcid health information may be collected, used and disclosed to others to find out
your eligibility for, to carry out, and to !e auaic the results of the research study. More
specifically. your proectred heJath information may be colkleted, used and disclosed or the
Iblloling sthudy-reiued purpose): to determine if our slf-hrclsh assesrineri and spiritual
beliefs and spiritual parlicpalLori are related I. your pain afler surgery.
2 9- 2uU1 /07-10-03 F Pae 4 of 7
17. Who will be authorized to collect, use and disclose to otfbrs your protected health
Your prolecled health r-formation may be collected, used, and disclosed to others by
the study Principal Investigator. Patricia A. McNalty
Dr. Peer Gearan, ChairnmuL Depanmenl of Onhopedii Shands at UF
ohir professionals oa the University of Florida or Shands Hospital thai provide study-
related ratment or procedures
The Univesity of Forida Institutional Review Boad
I1 Once collected or used, who may your projected health information be disclou-d lo?
SUS and foreign goviermenual aSencs who are responsible for overseeing reach,
such as the Food ad Drug Adrmnistration. the Department of Heakh and Human
Services, and the Oilice ojF Huan Research Prolcclbons
Government agencies who are responsible for overseeing public health cones such
as the Centers for Disease Cotrol and Federal, State ad local health departments
19. Ifyou agree to partlcipale ln bis research, bow lo will your protected health
information be collected, used and disclmed?
Your projected heallh inbrnmaion will be used and disclosed forever.
20. Why are you being lasdt roe turhorhz Ihe collection, use mad disclosure to orher afyour
protected health inornmalion?
Under a new Federal Law, researches cannot collect, u.e or djsclor any ofyoa prolclicd
heacih [nifmu ion for research unless you allow them to by signing this canse arJ
21. Are you required to sign this content and authorizatin and allw the researchen to
collect, use and discose (give) to others ofyour protected health information?
No. and voLr reiual ro sign wilm nt alffcl yor Ircalnmeni, payment, oero1Mb nl, or eliibilty
for any benefits outside this research study. fHoiver, you cannot participate In tis research
unless you allow rhe collection, use ard dtscairir'e iftyrir protected he lth mrobrowaion bi
signing shis cwfasendmfrkorlaftio
259-2003 / 07-10-03 / Page 5 of 7
22. Can you review or copy your protected health infomatioR collNcted, used or disclosed
under iis aulboratlion?
You hanw the righ to review and copy your projected health infonnrion Howvr, you will
not be allowed to do so until after the study is finished.
23. is there a risk tht your prorwled health Ina rma ion could be given to others beyond
Yes. There is a nmk Lhat injornuiCOn received by owlhorized psernS couDJ be given to others
beyond your aufthrizalion and rit covered by the law.
24. Can you revoke (cancel) your nuthortbtion for colectiona use and disclosure ofyour
protected health Information?
Yes. You fcn ca-.el your aLuLhrizaion a1 iny time before, during or aflnr you pnnicipaiion in
the rcscuch. Ifyou cancl, n nnew inform ationr wil be collected about you. However,
infornation tht wnas ready collected may be sVM be used and disclosed to others if the
researchers have crlied on it to complete and project the vraLidny ofrie research You can
cancel by giving a wrInLn reqicsi whih 3our signature n hi to the l'rinipal lnuesiigioor
25. How t ll rhe researchers) benefit from your being In this study?
In gcr erdi. prcscninfl research results helps carmLr uo scientli Tlhrcrore, ihe Principal
invesialor may beneEf if lhe result orfhis trudy are prCesnted t siehulrIC nrcing or in
259-2003 / 07-10-03 / Page 6 of 7
As a representative of this study, I hav explained to the participant th purposL4 the
procedures, the possie benets, and ihe risks of his search study; the alternatives to being
in ihe study, and how the pnrticipdan's proicled hr lrh inrormnilon wil be collected used and
Signacl of Person Obnining Consern and Authcriarmon Date
You have been informed about thi study's purpose, pocedres, possible benefits, and risks;
the alternatives to beirg n he study. and how your protected hcnhh infomnlion wifl be
covected. used and disclosed. You hImc recc. cd a copy of his Form. You have been given
the opportunity to ask quer ians before you sign, and you have been told that you cn ask other
questions at any tmne.
You olunrilyarn agree co parikipate in this sudy You herchy aulhorize he colBection, use and
Lisclosure ofyaur proiecied thelrh unformalian us d-cribcd ir setIonm. 14-24 above, By
signing this f you are not tiiving any of your legal rngrh;
Signature ofPerson Consening and Aulhorizing Date
259-2003 07-10.03 / Page 7 of7
INFORMED CONSENT 01-29-04 TO 07-15-04
Informed Conset to Paricipae in Research
and Autkhorriaon for Collecion, Use, and
Dicrlosure of Protected Health Itnformamion
University of lorida
Inslitutional Review Board
APPROVED FOR USE
From I J/ o./ Through 7, /^/0
Yolu ar being asked to take pIt in a research study. This form provides you with information
about die study and sees your aulhorizalion for the collection, us and dis lI run:r L your
proteclcd health information necessary for the study. The Principal l i ics;I lc.r ( Lh person in
charge of this research) era representat ivofthe Principal Lrivemigaior will nlio Jdcs:nbe thi- ijuly
to you end answer all ofyour questions. Before you decide whether or not to lake par, read the
inmfonaionn below and ask cqucstrion abCtui an.U lliring )jo dJo njiot understand. Your particIpaliaLo L
L. Name or Pn.ariipint ("Study Subject")
2. TIle of Resenrch Study
Effects ofSpiritual Beliefs and Involvement and a Posiltve Self-HelLh Assessment in
Prdliclng Postoperative Analgesic Medication Use in Total Joint Arhroplasty in Ihc Older
3. Principal Tn% esaiglor and Telephone Number(s)
Patricia Anne Mc N.ll)
4. Source of Funding or Other Material Support
University of Florida
259-120031 Rv Ol7.27-04/ ~ge 1 of 7
5. Whal is the purpose of this research study?
You are being asked if you are inicrcscdj in p.aicip.liing in this study because you are
scheduled forjoin replacement ,urer Tins srudy i b ing do~ to scc if there is a
rcliaionship bctwcn your spiritual beliefs ain your: ellc evaluation and your need for pain
medicine. Tie purpose ofthis sludy is to measure the amount oCpain medication you use for
the first tree days Ailr your surgery.
6. What will be done if you take par in this research study?
You will be asked to puriAipaic in Ihs study allcr you have been scheduled with Dr. Gc;rc~i.
Dr. Myers, or Dr. Vlasak for hip or kne replaccaernt surgery. Through your participation in
ihis study you will be asked to complcle two survey questionnaires. These survey
qliisl;onnoircs will Inta uipron\ila[cI 20 minutes to complex,. You do not have to answer
all of the questions if you do not wanl I ans.cr all The purpose oflthis sludy is Io explore
reltioinships between spiritual dclicf1, spirilital involvement, a personal hall evaluation
and the amount of pain nudicariin use aRlr joinil rcplacmoncl surgery. Your medical record
will be cxainned for three days after surgery to determine the amount of pain you report after
surgery and the amount of pain medication you use. Other information examined from your
medical record will include your age. sex, diagnosis, location ofjoint eplaoen nl atnd
ansllhesia given to you during yo surgery. ThS Principal Invcstigator will code all of yrur
information wilh confidential code numbers. All ofyour daa will kepl in a locked secure
All o your care will be normal procedures that re part of thc treatment for all patients
having, lotal joint replacement surgery. There will be n iliu n uiiccrin your Irealmcnl while
you ire part IrFlh; s.1mily
7. What are the possible discomforts and risks?
Ilcre w ill be no po:sibli ri.l,. for you as a pw;ric;pinl in ihis study. You nmayexperince
discomfort in answering qiuJerionr rc~grdi;ng your spiritualiy.
Throughout the study, the rzcserclier %..i]l IdcIul'y yu of ew informaltion that may bcornue
available that may ufacct your decision to remain in the study.
iryou wish to discuss Ihe information above or any discomforts you may experience, you may
ask questions now or call he Principal [nvesigatror contact person listed on the front page of
8a. What are the pouiblre lirnerli tn ou?
There are no bencils to you as part ofthis study.
259-2003D Rev 01,27-04 /pTa ",c- 'i
8b. What are the possible benefits to others?
[ this study should show a rclaionship between spiritual beliefs, tpiri mal p.ir;icipaiion,
personal health evaluation and pain medication use, oLther sudies nay I e incrin 1i develop
allcrnalive ways to treat patients in Ihe future.
9. ir you choose to take part In this riearch urud., will it cost omu anything?
There will be no charge to you For being part of Ihs study.
10. Will you receive compensallon for taking part in this research study?
You will not be paid for taking part in this study.
i What if you are injured because of the study?
If you experience n injury ih,[ is dircvcly caisid by thLs iuJy. oily prlf5ssioal consullative
care Ihat you receive at the University of Florida Healit Science Center will be provided
without charge. However, hospital expenses will have to be paid by you or your insurance
provider No ontiir coripcnniicin is offierd
IL2 What olhrr option or trrat m(a rire a c ailahcl if you do not want lo be In Lhis stud)?
You are Free to choose not to take part in [his study. If you chose not to take part in this
study, yourjoint replacement surgery will continue and you will receive the same level of
care If you do not want to take part in LhI i ~udy. tell the Principal Invcsligalor or her
assistant and do not sign this Informed Consent Formi
13n. Can you wlllhdraw from this research olud) .
You are fre to withdraw your consent and to slap panicip ling in this search study at any
rime. If ou Jo 'viilhdr o )or con.wnr. there will be no penally, and you will nol lose any
benefits you are entitled to.
II you dec, ide no wulniri-w your consent to participate in this research study for any reason, you
should contact Patricia Arne McNally at *3'52, 21 -7452.
If you have any questions regarling your righ as a research subject, you nay phone the
Institutional Rc-lew Ejrd (iRBi oicc F l (.1521 46-.194.-
13b. If you withdraw, can Information about you still be used and/or collected?
If you withdraw from the study, the Principal Investigator would like lo continue to keep and
2 9-2003 t/ r 0v L-214 / Page 3 or7
use the information ih.at yoi corr1pFl)cd using ihe qluisiornaires, pain scores, pain medicine -
and oilier information oblained from your medical record. If you refuse to let ihe Principal
Invesligalor continue to keep and use this inirmialion, it will not be used.
13e. Can the Principal In cstnigitor withdraw you from this research srudy?
You may be u ihdrain from the study without your consent for the following reasons:
SYou did not qualify to be in dIe study because you do not meet the study
requirements. Ask the Principal Invesligaor i you would like more infonnmaion
14. How will your privacy and the confdenlela.lly of your prrretrld health infnrmalWnh be
Data will be gathered and maintained using confidential codes to protect your identity. Patricia
McNally. the Principal Ir' scligpor. will gather medical data obtained from your medical
record. All dala and information will be kepl in a locked rile in the police ofPaTui ciE McNlly,
I|Lu Pnricipal [vestigator, Patiicia TlMcNall dill assign all confidential code numbers. Access
to your Fle will be restricted Io ihe Principal Investigator,
if you participate in this research, your protected health information will he co lkl.-d. used, and
disclosed under the te=s specified in secions 15 24 below.
15. If you agree o participate in Ib s research slud). bhat proiLert-d hea lh idfornArian
about you may be coUeted, used and disclosed to others?
To dLirreir Lc ui c! igibili Ly if the sIudy and as paIr oI your participation in the study, your
prolected heallh infrmnalion that is obtained from you, fro review of your past, cuarcn or
future health rcconls, from procedures such as physical examinalions, x--nys, blood or urine
less or other procedures, rom your response to any study treatments you receive, from your
study visits and phone calls, and any oLliier asudy rriar-d IL akh information, maybe collected,
used and disclosed to others. More specifically, tie following in frunritiion ma y bK collecled,
used, and disclosed to others:
Complete past medicaL history to dalerninc eligibility criteria listed in informed
Questioniaires that you have completed
SIMcdical rc-rd 1 aboful yourjoint replacement surgery
SMedical records about pain niedcalion use after surgery
SMedical records about pain reporlcd
Medical records about anesthesia used during surgery
259-2003 / RcV 01-21-.4 I'Pac 4 of 7
16. For what slud%-relaied purposes will your proteclod health information hb IclleclCd, used .
and disclosed to olbers?
Your protected health inrfomation may be collccled, used and disclosed to others to lind out
)ouc cligibilily for, lo carry o' aani is ievalu.ai1,Is il-resuh of [he rec sarn study. More
S .' Fticall. your prOLcMLCd health informJltioi nmay bccciL cct used and disclosed fo r he
following study-relaed purpose(s):
Sto dclcrminc '1 your selF-illalll i rsncmrnt and spinliual bliefs ad rpJ ninal
participation arc related to your pain after surgery.
17. Who wll be authllorized o collect, use and distrlse to others orur protected benlll.
Your projected health inrbormnion may be collected, used, and disclosed Io otherC by:
Ihe sluJy Principal Investigalor. Patricia A. McNally
SDr. Per Gearen, Chainnan, Department of Orthopedics Shnds :i UF
oljer pro fisionals ai Ihe Uniln rsily of Fori da or Shands Hospital tha! proi; siuJv-
related irealmeni or pmledures
The University of Florida Instilutional Review Board
I. Once collected or used, wiso may your proie~tcd health information be disclosed le?
Your proteled health information may be given to:
United States and foreign oriimniernal 3agenc js -.FW iac responsible for overseeing
research, such as the Food and Drug Administralion. lhe D'p rrFmnrlt ofEcallh and
Human Services, and the Olfice ofrHuman Research Protections
Government agencies who are responsible for oVers~r ing public hc aih conc rrn i ch ~s
the Centers for Disease Control and Federal, Stale and local health departments
19. If you ngree to pnrliclpate in Ibis research, how long will your proteetrd health
information be colleled, used and disclosed?
Your protected health information will he colleled until the end of ihe srudy, This
information will be used and disclosed forever sine it will be stored for an indeinile period
of time in a secure dainbas.
259-20031Revo01,27-04: l'iL,c ?
20. Why are you being asked to authorize the colleclion, use and disclosure to oihrs ofyour _
protected health information? -- .
Inder a new Federal Law, tesearhecs cannot collect, use or disclose ry oar~iour priorlece
heallll inflorr'ion for research unless you allow them to by signing Ihis crnsnt and
21, Are you required to sign this consent and authorlzallon and allow the researchers to
colIect, use and disclose (gisc) lo others of jour proiecled health information?
No, and your refusal to sign will nol afei'i your treatcnt, payment, cirollnrenti, Lreligibiilty
for any benlils outside tUis research study. However, you carJemo puirtr epa e in ld rfearclh
less you allow ite colleactri, ufenr orVl lisclosure of iiur prit;ectelhearih information by
sigdng this consentauthoriztion.
22. Can you review or copy your protected health Informalion collected, used or disclosed
under Ibis authorization?
You have the righi to review and copy your protected health infonntmion. Htlow. e. you will
not be allowed to do so unlil after ihe study is finished.
23. Is there a risl that your protected hbeth information could be given to others beyond
Yes. There isa risk that information received b) -unihori/ed persons could be given to others
beyond your authorization and not covered by i e law.
24. Can you rn uke (cancel) our aulbnorization for Ltoltion. useand dlsclosureor your
proleeied hralih information?
Yes. You .cincancel your auiuhoriil'(rt at any time before, during or oafer your participalion in
rie research. Ifyou cancel, no new information will be colJecied ambui you. However,
information Ila iass already collet rd im..y be slll be used and disclosed to oth s ifthe
researchers have relied on it wo currpleie and pruicci tihe ;dciill of ite rLse3arch You can
cancel bygiving a "vnhin rcquei u IC )t your sipnalurc on it to Ihe IPnrnip:I hIliiigator.
25. How will lte rsen reheril-s benefit from your bring in this study?
In general, presenting research results helps the career or a scienlis. Therefore, the Prinipal
]i ts Lnig. t. ma~ bcnefi if the results oflhis study are presented at scientific meetings or in
259-2003 / Rev 01.27.41 ligc of 7
As a representative of Uis study, I hIve explained to the participant the pLurpse, the
procedures, Ihe possible bir fisL. and Ihe risks of this research study; Ihi alternatives to being
ini the 51udy. and how the participant's protected health infoTmaton will be collected, usel, and
Si griauur of Peron ObLt ning CoInsIe ani Aulhon-alon Dale
You have been informed about this study'spurposc procedures. poaible benefit, anr nskst.
theallcnalivcs [o being in Lh2 sNudy. and howv your potected health information will be
collocietd. used and disclosed. You have received a copy of this Fonm You have been given
lthe opportunity lo ask questions bclirc you sign. and you have been told that you can ask other
questions ai any line.
'ou volunU~rily agree to palicipalt in this study. You hrreb" .uuLhori.h the .lkction, use and
disclosure oryour prolecled health information as described in sections 15-24 above. By
signing this ronrm you are not waiving any o your legal rights.
Signature ofPcrson Consenting and Aullhorizing
25900W IRcrv o1-27-04 / Pag 7 of 7
INFORMED CONSENT 07-16-04 TO 07-15-05
hIfon irm Consent to Paniidpnte in Research
and Authofriation for ColteeioMn, r, an d
Disclosure ofPrateced Health lifororaton
University of Florida
lnstltutional Redew Board
APPROVED FOR USE
_Fr -4om__ Through V14.47.r
You are being asked to lake part in a rsarcmh study. This form provides you wi h inlbrri lion
about ie study and seeks tour auithorin.aion for the collection usc nd disclosure aof yu
proecrid hea in irlbfor-minion nccLssarl for Ihe sludy. The Principal Inc si~aigor (die peron in
ichw;a oflhis rcA&erch) or a rcprcrsnlaiie of lIhe Principal Investigalor will also describe Ihis sludy
lo )ou arid jiriswLTr all ofyour questions. Your pilricipallr n is entirely voluntary. Before you
decide wlielher or not to take pan. ri.jl he iniomrrniaLn below irid ad. quiesiiont abcul ma)hin
you do nol understand. 1i you choose notr 1 participate in II~s s5Idy )ou will not be peniialcd or
laic lrny baiclils thai you woUld thterwAise be eirirEllnj l.
1. Nameof Participint ("Study Subject")
2. T'ileof RfslarchSludy
Eff is of Spiri;ual Beliefs and Involvement and a Positilc Seir-l lealdi A.-l5sin-iFci in
Prrdiciing Postoperative Analgesic Medicaion Use in Tolal Joint Artiroplasty in Ihe Older
3. Princpnl InTieslgalor and Telcphoae NunmbP~is)
Pairicia Anne McNally
4. Source of Funding or Other Mncerril Support
259-2003/Rev 6 4.4 /P Fc I of 7
5, Whal is the purpose of this research study!
You .ce being asked if you are interested in participating in this study because you are
scheduled for joint replacement surgery. This study is being done to sea if there is a
relationship belween yoLir spiri ual beliefs and your health evaluation and your need for pain
medicine, "Te pu-jpos of ih atludy is to measure the amount of pain inediehiiOn you use for
the frsi three dayi after your surgery,
6. Whnt will be done If you take part In this research sludy?
You will be asked to participate in this sludy after you have been scheduled wilh Dr. Gearen.
Dr. Myers, or Dr, Vlasak for hip or knee replacement surgery. Through your participation in
this study you will be asked to conrpile Iwo sure queslionnaires. These survey
questionnaires will take approximately 20 minutes to comptele. You do not have o answer
all of the questions if you do not want lo answer all. The purpose of this study is ln cmprincE
relationships between spiritual beliefs, spiritual involvement, a personal health evaluation
and the amount oflpaiin irdicalaion use after join replicirnini surgery. Your medical record
will be examined fcr there days ailer surgery to determine the amount of pain you report after
surgery and the amount ofpain medication you use. Oitlr inormiaiion etrnirncd from your
niedical record will includuc iour age, sex, dl.gnosis. loCAlIon ol'joint replacement and
anesthesia given to you during your surgery. The Principal Invesligalor will code all of your
informnlion wiih confidential code numbers, All orfyour data will kept in a locked secure
All of your care will be normal procedures that are part of the ircatment for all patients
having tolal joint replacement surgery. ThLre Iill be no diTerences in your treatment white
you are part of this study.
7. What nre she possible discomforts and risks.
'Thee % il1 be no poNssibl nsks for yci as a pa ticiprnl in this study. You may experience
discomfort in answering queinions regardriin, our spintiulal').
Thrlouia1uii ihc sirdy. the researcher will nolify you of new information Ihait rmy become
available that may affect your decision to remain in the study.
If you wish to discuss the information above or any disconforts you may experience, you may
ask questions now or call the Principal Investigalor or contact person listed on the front page of
SaB What are the possible benefits to you?
There are no benefils Io you as par of Lhis study.
259-2003 / Rv 06-144 / Page 2 of 7
81. What are the possible benefits to others?
If Ihis iudry should show a relationship between spiritual beliefs, spiritual paiicip.Ilion.
personal hcallh evaluation and pain medication use, olher studies may be done to develop
allemative ways to Ircat patients in the future.
9. If you choose to take part in this research itud will it cost you anything?
There will be no charge to you for being part ofthis sludy.
10. WIl you receive compensation for taking part in this research study?
You will not be paid irr Ik in g part in this study.
11. What [fyou are Injured because or the studio ?
IFyou experience an injury that is directly caused by thii& study, only prifie.'iunal consultative
care that you res; c iiL the Uri crsily ofFlorida Health Science Center will be provide
.-irhoul chirgc. I Ich. o .-r. hospiinl expenses will have I be paid by you or your insurance
provider. No olh-r compeisilion is oflTfr Please contact the Principal Investialor listed in
Item 3 of this fImOi I yoLL \pc ricnce an injury or have any questions about any discomforts
that you experience while participating in this study.
12. What other oplioni or Irenrments nre aiallable If you do not want to be in ihis ludy?
You are free to choose not to take pan in this study. If you chose not to take part in this
study, yourjoiint replacceninc surgIery will continue mad you will receive Uth suam level of
are. if you do no want to take part in this study, tell the Principal Investigato or her
assistant and do not sign this Informed Consent Form.
3an. Can you nwitdraw from this research study?
You ar free to withdraw your consent and to stop participating in Lhis research sludy at any
time. if you do v6ilJhdiraw our conscri, there will be no penalty. and you will not lose any
benefits you are entitled to.
If you decide to widldraw your consent to participate in this eearh study fbr any reason, you
should contact Patricia Anne McNally at (352)28 1-7452.
If you hav an) q actions regarding your rihl as a research subject you may phone the
Instilulional Review Board (RB) office al 1352p 846-1 49-4.
259.2M00 3 Rev 06-1-041 Page 3 of 7
13b. If you "%ilhdran. can information about you still he used undinr collected?
If you withdraw from tie study, the Principnl Investigulor would like to continue to keep and
use the information ilat you complete using Ihe questionnaires, pain scores, pain medicine
and olher infornaiion obtained from sour iili~al record. If you refuse to let the Principal
Irn ctigsator corlinuc to keep and use this inf rmniiori, it will not be used.
13e. Can the Principal Investigator withdraw you from this research study?
You may be withdrawn from hde sludy without your consent for the following reasons:
You did not qu.ilif) Ho 'c- in the study because you do not meet the study
requireonentis Ask the Principal Investigator if you would like more infbormalion
14. How will your privacy and the conflidencialir of )our prolected health informnaila be
D)la will be 4i.hcl.iLd a-ld nriinlaincJd using conldential codes to protect your identity. Patricia
McNally, the Pnicipal Investigator, will gather medical daa obtained from your medical
record. All data and infonnalion ill bI kept ni a lxked ile in WUiL ofITe:c of Patricia McNally,
the Principal nvcstigator. Patricia McNally will assign all confidential code rnwbers. Access
to your file will be restricled to the Principal Investigator.
If you participate in tlis research, your projected health information will be collected, used, and
disclosed under the iiens specified in sections 15- 24 below.
15. Ifyou agree to parllcipale in hiis research siudy. what protected health information
nhout you may be collected, used and disclosed to others?
To determine your eligibility for die study and as part of our panicipr lion n the study, your
protected health ifornalion tant is obtained from you, from review of your past, cu ren or
JurLUic hc iJLh rccords, from procedures such as pl.) i-c examinations, x-rays, blood or urine
tesis or other procedures, from your response to any study trealmenis you receive, from your
study hisii5 and phone calls. nnd aniy other slud) relat-d hcalih ini m.ilcior. rniy be collected,
used and disclosed to others More spec icnll., the following infonnalion may be collected
used, and disclosed to others:
Complete past medical history a delerin eligiili c rcrineia lisrd in informed
SQuestionnaires thai you have comptcled
SMedical records about yourjoint replacement surgery
Medical records about pain medication use after surgery
Medical records aboul pain reported
Medical records about anesthesia used during surgery
-259*003 I ev 06Rc 4.- Pa 4 of7
16. For wbat sludy-related purposes %ill your prolecLed hnlllh in ormation be collected, used
and discloIed to others?
Your proTecile hcj.ih i nforiaiori may be collected, used and disclosed l otlirs to ind oul
)our c I ig]hil] I f'Tr. to carry ou, and to evaluate the results oflhc research study. More
spiT.ilkla ly. your prlolcted health inlrcmiarion maybe collected, used and disclosed for te
Iollo.ing nudy-r.laiqd purpoae(s)
to dlcrrnie i'your s-lf-halil]i ;ssisn l enr and spntual beliefs and spiritual
pan;cip.j ion are rcialed to your pain after surgery,
17, Who will be auirlorlzed to sijlitcl. use and diclos lto others your protected health
Youw prolecced Ilealll infoermition maybe collecied, used, and disc.ors d to others by:
tlic sudy Principal invesigator. Patricia A MciNaJl
Dr. Peter Cearen, Chairman, Department or'Onhopediii. Sliar s at UF
oihcr professorilsl at rhe Univerity of Flonda arSh~nds Ho1lsilhi hal prio' mlC saidy-
rclated treatment or procedures
Th University of Forida Instituional Review Board
18. Once rollectrd or used, who may your protected health information be disclosed to?
Your protlcled health information may be given to:
SUniled Slates and foreign governmental agencies who are responsible for ovrseeing
tresarh. such as the Food iirsi Drug Adminiriinior.u Ihe Department of leallh and
Human Services, and the OiTicc of Hinan Research Proteclions
9 Govemment agencies who are responsible for ovcrsceiri public Iheith conccns such la
the cntlers for Disease Control and Federal, Stame uid ]ccal healIh depatnients
19. If you or9et to pnrlicipale In this rcsnerch, how long will your protected hellth
information be collcilcd, used nnd dlL.closed?
Your protected health infoamaion will be collected until the end oflhe study This
information will be used and disclosed forever since it will be scored for an indefinte period
of time in a secure database.
259-S03 I Revy0&1.4W I/Pftt ~ of 7
20. Why are you being asked to aultoriz the collccrion, use and dicTrourt ro oiheri uf your
projected health information?
Under j nc". FodcraJ Law, rrcfrcher crulrnnr ol [Ml. s or disclose any oryour protected
eallth information for research unless vwo allow dlnlrn o b.y signing this consent and
21. Are you required to sign this consent and iullorization and allow the researchers to
collect, use and disclose (give) lo others of your protected benllh Informatloit?
No, and your refusal lo sign will not arect your treatimen, payment, enrollment, or eligibiyII
j;r an l b~ienefiP oLIIsrLJc ibh rcsairch slud). Hoi'.'ver '%u canxI t pjanicipate in this research
,.iMrss, aliathi ir. cotlcorrrf, ,tiF er'd Sio.rlrre 0j' rifr proSectd heakh infonrmatmo hNi
signing this consest/lauthorizotion,
12. Can you reticn or copyyour protected healJt tnformaorinu collcchid, used or dllosed
under this authlorizatlon?
You har thc ri ghr to review and copy your protected health inforrntion. However, you' ill
not be allowed lo do so until altr the study is 1rishei.,
23, Is there a risk Ihnt Nour proleried heaolh Information could be given In ohenrs beyond
Yes. There is a risk thjl iiifoBmacion received by auhorizcd persons could be given to others
beyond yotr authorization and not covered by the law,
24. Can you rccie (cancell) yur nauhortzallon for collection, use and disclosure of your
projected health information?
Yes. You can cancel your authorization .11 any itim before, during cr .iaTr yoLo p;ricip.illor jn
the research. If you cancel, no new information will be collected about y However,
infonnation ihat was already collected may still be used and disclosed to others ifthe
researchers have relied on it locomplete and proi i Vt i.V.LdiI) ol'hc icicarch. You can
cancel by giin5 a writer rcques- with your signalureon [i io the Priinipal In,%clIgatr.
25. How %1ll Ilhe rtesorchLr(sj henefit rrom 3our being In ibis study?
In scrwirl. prcscrninI rIMesearci r culls help dime career ol a scientist. Therefore, the Pricipal
[tIiwesigior mra' bcnclii irthe resulls ofthis study are prtenltd at scientific meetings or in
Sl iellfic jCiumr js.
259-20031 /Rev 0614-04 / Pa6 of 7
As a representative of ihis sudy, have explained lo ihe participant the pupose. Ihe
procedures, the possible bent fit, and Ihe risks or ihis rcarch sludy. ihe all'm.nitcs to being
in iliSe tuil, and how Ihc parieipail's protected health information will be collected, used, and
Signaiiun or Person Obtaining Consent and Authorizaion Date
You have been infonned about this sludy's ptupse, procedures, possibLo bmeielt, and risks;
ihe attemntves to being in the sludy, and ihow vyor prniecied ]i llh informilion will be
;oll]ccid, used and disclosed. You have received a copy ofthis Form. You have been given
ilt; opponuilly l Io ak qurslionrs be re[ n siln. and you hjae been iold imwr you can ask other
questions at ant iime
You voluntarily agr i io pirniCipai in ihis study. You liheby auiuhorir c Lhc icolcciion. us aid
disclosuir of your protected halth inromalion as described in sections 15-24 above. By
signing dl.s, J rin, you are nol waiving any afPaur Icgl nJghtl,
Signalure of Person Consenling and Authorizing Dale
250M2003 Rev 06-14-1 f Pa 7 of7
THE SHORT FORM-36 HEALTH SURVEY-SPIRITUAL INVOLVEMENT AND
The Short-Form-36 Health Survey
Instructions: This survey asks for your views about your health.
Answer every question by circling your response. If you are unsure about how to
answer a question, please give the best answer you can.
Question I Very
Excellent Good Good Fair Poor
In general would you say you health is: 1 2 3 4 5
Question 2 Much Somewhat About the Somewhat Much
Beter Now' Better Now Same Now WorseNow Worse Now
Compared to one year ago, how would 1 2 3 4 5
you rate your health in general now?
Question 3 The followmg items are about activities you might do during a typical day- Does your heaibh now limit
you in these activities? If so, how much?
Activities Yes, Yes, No, Not
Limited A Lt Limited A Little Limited At All
a. Vigorous activities, such as running, lifting heavy 1 2 3
objects, iFtidcip;tirng in strenuous sports
b. Moderate activities, such as moving a table, pushing a 1 2 3
vacuum clear, bowling, or playing golf
c. Lifting or carrying groceries 1 2 3
d. Climbing several flights of stairs 1 2 3
e. Climbing one flight of stairs 1 2 3
f. Bending, kneeling, or stooping 1 2 3
g. Walking more than a mile 1 2 3
h. Walking several blocks 1 2 3
i. Walking one block I 2 3
j. Bathing or dressing yourself 1 2 3
During the past 4 weeks, have you had any of the following; problems with your work or
other regular daily activities as a resrdr of yonr physical health? Yes No
a. Cut down on the amount of time you spent on work or other activities 1 2
b. Accomplished less than you would like 1 2
c. Were limited in the kind of work or other activities 1 2
d. Had difficulty performing the work or other activities (for example, it took 1 2
During the past 4 weeks, have you had any of the following problems with your work or
other regular daily activities as a result of any emolonal problems (such as feeling
depressed or anxious)? Yes No
a. Cut down on the amount of time you spent on work or other activities 1 2
b. Accomplished less than you would like 1 2
c. Didn't do work or other activities as carefully as usual 1 2
Not at All Slightly Moderately Quite a Bit Extremely
During the past 4 weeks, to what extent has
your physical health or emotional problems 1 2 3 4 5
interfered with your normal social activities
with family, friends, neighbors, or groups?
Question 7 Very Very
None Mild Mild Moderate Severe Severe
How much bodily pain have you had during 1 2 3 4 5 6
the past 4 weeks
Question 8 A Little Quite
Not at All Bit Moderately a Bit Extremely
During the past 4 weeks, how much did pain
interfere with your normal work including 1 2 3 4 5
both work outside the home and housework)?
Question 9 These questions are about how you feel and how things have been with you during the past 4 weeks. For
each question, please give the one answer that comes closest to the way you have been feeling. How much of the time
during the past 4 weeks --
ALL of Most of A Good Bit Some of A Little of None of
the Time the Time of the Time the Time Time the Time
a. Did you feel full of pep? 1 2 3 4 5 6
b, Have you been a very 1 2 3 4 5 6
c. Have you felt so down in the dumps 1 2 3 4 5 6
that nothing could cheer you up?
d. Have you fll calm and peaceful? 1 2 3 4 5 6
e. Did you have a lot of energy? 1 2 3 4 5 6
f. Have you felt downhearted and I 2 3 4 5 6
g. Did you feel worn out? 1 2 3 4 5 6
h. Have you been a happy person? 1 2 3 4 5 6
i. Did you feel fired' 1 2 3 4 5 6
Question 10 All of Most of Some of A Litt of None of
the Time the Time the Time the Time the Time
During the past 4 weeks, how much' of the
time has your physical health or emotional
problems interfered with your social 1 2 3 4 5
activities (like visiting with friends,
How TRUE or FALSE is each of the Definitely Mostly Don't Mostly Definitely
following srirnements for you? True True Know False False
a. I seem to get sick a little easier than 1 2 3 4 5
b. I am as healthy as anybody I know 1 2 3 4 5
c. I expect my health to get worse 1 2 3 4 5
d. My health is excellent 1 2 3 4 5
2) Spiritual Involvement and Beliefs Scale (39 item version) Hatchet atl
Unhraity of Florida)
How strongly do you agi with the fomlowig stalemew.? Plcasmcirdcyour rtspose..
-Srog Mai3y Mi diy sbng
Agm Agc Arr e M NtrMl DBm Disp Dfa Ie
I. I s aside t ea for nredhaLion andloi
2. I n find meaning in times of
3.A prsoo can be fuiLled witlbh
pursuing an active spiritual life.
4-1 find isaerilyby accepting hihgs as
S Som rcxpriencs can be understood
only through ones spirile beliefs.
61do not believe in an afterlife.
7.A spiritual force influnccs Ihe events
in my life.
8. kLuwI n iclIonsl-up wlht ScmnWDe I
can turn lc for spiritual guidance-
9.Pmyrrs do not really change whale
1 OPatcipating pi spiilual activities
helps me forgive other people.
1 l. fl inner peace when I am in
harmony with nature
12. Ewrylhing happens for eaer
131 use contemplation to ge in touch
with rmytru self.
7 6 5 4 3 2 1
7 6 5 4 3 2 1
7 6 5 4 3 2
7 6 5 4 3 2 1
6 5 4 3 2 1
7 6 5 4 3 2 I
7 6 5 4 3 2 i
7 6 5 4 3 2
7 6 5 4 3 '2 I
7 6 5 4 3 2
7 6 5 4 3 2 1
14. My spirual Ie i fills me i ways
ltar maria pcviwssiosr do not.
153 rarely feel connected 1o something
gpear ail anmyself
16.1n i e of despair I can find itle
reason 10 hope.
17t.'W I am sick, I would li~ olber
to pry for mr.
18J 4avc a pcrwOl reblaondhip with a
power greala than myself
19.1 hae had i spiritual cxpaeriene Ith
nitaily lunged mry if
20. Wte I hlp olbe s, I expect nothing
211 don'l take time to appreiate nature
22.1 depend on a higher power.
231 have joy in my life because of my
24My reh ionshipwith a hiltr povrcr
hlps me love others moreclmqplktey.
25.SpLilald writings rm-ich mry li~.
26.1 have eperinced hearing after
27. My spiritual ustrstandding
coninues to gow.
2&. I am rigl t mre ofin iAnu moM
?9 Maei s;piJriu approaches have linle
7 6 5 4 3 2 t
Strangly MBd Mdly Stronq
Agree Ari Agree et"nl Disagre DisBgr Disa
.7 6 5 4 3 2 1
7 6 5
7 6 5
7 6 5
7 6 5
7 6 5
4 3 2
4 3 2 [
4 3 2 1
4 3 2 I
4 3 2 I
7 6 5
4 3 2 I
7 6 5
7 6 5
7 6 :5
4 3 2 3
4 3 2
4 3 2
30. SpiriL halth contibutes to
31.1 regularly inertct with others lor
32.1 frac on vhar nreds to be chmgvcd
in Ie, no~ on what needs o be cdaged
33. In dillicoU tdrcs, I am still graktcL
341 Ihav been through a tBim ofgreal
sunHring thoal d o spmruia growth.
Srangly Mityl Mi~tly Slroa
Agr Ag re Agre e Dnrgc grec Diagr
7 6 5 4 3 2 t
7 6 5 4 3 _2 1
7 6 5 4 3 2 1
6 5 4 3 2 I
7 6 $
4 3 2 1
Please indicate bow often you do the following:
35.Wbn I wron sonoItne I make an
effort to npoogizc
36.1 acccpi oaer asthey are.
37.1 sole 4y problem without using
381 examine my a~ions to see if ty
mt Some- Nor AlmI N
wrys uy ims BsaBy w 3 N
6 5 4 3 2 i
7 6 5 4 3 2 1
7 6 5 4 3 2 1
7 6 5 4 3 2 I
39. Iow spiritual a person do you insider yourself? (With "7" being the nIm
1 2 3 4 5 6 7
Rvrm sccrme all mplctiy w~mrdW ieasu (3.6A5l.162l2.E9-iTi
i.e. Slitg~ AAgrfte 1. Ag e 2, ..... SuagLy Disagr 7
or Albys L. Albu Alwa 2, ....New. 7
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