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MUSIC THERAPY AS A POST-OPERATIVE MECHANISM FOR PAIN

MANAGEMENT IN CHILDREN

A Thesis

Presented to the Faculty of the Graduate School

of Cornell University

In Partial Fulfillment of the Requirements for the Degree of

Master of Science in Health Science

by Danielle C. Belknap January 2011

UMI Number: 1490031

All rights reserved

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ABSTRACT

Problem: Pain in children during the post-operative period is a phenomenon that,

although is well understood, is often inadequately treated, and more frequently undertreated. Documentation has shown inadequate treatment of pain in children interferes with daily functioning, and has an emotional impact on the post-operative experience and overall medicinal experience. However, the use and integration of

music therapy as a means to cope with post-operative pain has proven to be beneficial and helps to prevent negative experiences as well as improve pain management.

Methods: Peer-reviewed articles and clinical trials over the past twenty years, which

explored assessment of pain, coping with post-operative pain in children as well as

effects of music therapy in pain management, were used via PubMed search through

the Cornell Medical College Library. Results: Results of this literature review

demonstrated that coping mechanisms in addition to pharmaceutical means improved

the amount of pain and overall post-operative experience in children. In addition to

coping mechanisms improving pain, music therapy decreased the level of pain

compared to the use of analgesics alone. The results proved children appeared happier and had a higher tolerance of pain. Conclusions: The use of analgesics is frequently used to treat pain in children; however, analgesics are often an inadequate method to

properly treat pain.

method for pain management in order to create a more manageable post-operative

experience for children.

Music therapy in addition to analgesics appears to be an adequate

BIOGRAPHICAL SKETCH

Danielle Belknap graduated from the College of Mount Saint Vincent with a Bachelor of Science in May 2003. She majored in Allied Health with a concentration in

systemic physiology. Danielle continued her studies to earn a Master of Science

Degree in Allied Health in January 2005. Following graduation, she worked full-time

as a Medical Direct Professional working with the mentally retarded/developmentally disabled population for four years. She expects to receive her second Masters degree

in Physician Assistant Studies in January 201 1.

m

Thank you to my parents and brothers. The road has been windy at times, but with your love, support and encouragement, I've been able to stay on track.

ACKNOWLEDGMENTS

Weill Cornell Physician Assistant Program

Family

Friends

?

TABLE OF CONTENTS

Biographical Sketch

Dedication

Acknowledgements

Table of Contents

List of Figures .

Review of the Literature

1.1 Introduction

1.2 Methods

1.3 Results

1.4 Discussion .

1.5 Conclusion

.

Research Proposal

2.1 Abstract

2.2 Aims

.

2.2.1 Project Overview

2.2.2 Research Questions

2.2.3 Specific Aims .

2.2.4 Hypothesis

2.3 Background and Significance

2.3.1 Background

2.3.2 Project Significance

.

2.4 Preliminary Studies

2.5 Research Design and Methods

2.5.1 Design.

2.5.2 Methods

2.5.3 Statistical Analysis

2.5.4 Limitations

2.5.5 Timeline

2.5.6 Conclusion

2.6 Summary .

References

vi

LIST OF FIGURES

Figure 1: Visual Analog Scale

.

vii

.

19

REVIEW OF THE LITERATURE

1.1

INTRODUCTION

Surgical patients inevitably experience pain following invasive procedures. Pain can be controlled through a variety of mechanisms; however, pain relief varies and is an individual experience, which may not always be adequate. Analgesics are

most commonly used to treat post-operative pain; however, nontraditional methods may include the use of music therapy. Analgesics administered to children are based

on typical dosing regimens, accounting for weight, frequency and the perceived pain

by caregivers. However, at times analgesic regimens may be either excessive or inadequate, especially when based on the provider's perception of the patient's pain, rather than adequately assessing pain. Pain may be perceived through verbal, facial,

bodily expressions or gestures, and behavior changes1. Pain is not only a subjective experience, it is, particularly in children, an emotional issue2. When dealt with

inadequately, pain may interfere with activities of daily living as well as impact the child negatively leading to negative views regarding medical procedures. However, music therapy may be a beneficial additive when considering pain management. Music therapy can be used and tailored to individual needs and is designed to promote wellness, manage stress, alleviate pain, and express feelings, all of which promote

healing and pain control3. Given pain management is frequently inadequate, it is

important to further explore the use of music therapy as an adjunct to analgesics in

children throughout the postoperative period4. Through careful exploration we will be

able to determine if music therapy is sufficient in children to promote adequate pain control and improve quality of life.

1

12

METHODS

Using the PubMed database via the Weill Cornell Medical College Library online, studies were identified using the search terms "music therapy" AND

"children", "music therapy" AND "children" AND "pain", "postoperative pain in

children", and "music therapy". Inclusion criteria limited search results to studies in

the past twenty five years. Research studies were excluded if the article was published more than twenty five years ago, if the full article could not be retrieved through the

Weill Cornell Medical College library either online or via Tripsaver. Fifteen articles

were identified for the literature review with further sources identified through the

references of the pertinent articles. In total, twenty-six articles were reviewed and

analyzed to provide further background information regarding music therapy and pain

control in children.

13

RESULTS

Post-operative pain in children is an inevitable occurrence. It is commonly inadequately controlled and varies from child to child. Children cope with pain in

different and numerous ways, but it has been noted that children deal with

postoperative pain through both pharmacological means and emotional support5.

Kankkunen conducted a study and found that children between the ages of one and seven years, who underwent an ambulatory surgical procedure, dealt with pain through

copious amounts of support given by their parents5. Support included touching,

special feeding, limited playing, eating ice cream, balancing emotions by strong

2

parental support networks, and establishing joy. Children were more apt to cope with and manage pain if they felt comfortable, felt a strong sense of support, and were

occupied with activities they enjoyed taking part in. Joyous activities served as a mind distracter and took their focus away from experienced pain.

Bennet-Branson focused on family influence on coping strategies in children

experiencing postoperative pain6. Her participants included thirty children aged seven

to nine years and 30 children aged 10 to 16 years, as well as their parents. Parents and children were interviewed to determine which methods were used to cope with postoperative pain the day after surgery. All children found a variety of helpful self- control strategies to manage their pain. However, older children were more likely than those younger in age to use cognitive coping strategies. The usage of coping

strategies, frequencies of catastrophizing thoughts were highly predictive of all the

children's pain, distress, and physical recovery; implementing coping and reducing negative thoughts decreased pain, distress and improved their recovery period.

Results showed that the level of parental anxiety was directly correlated with child

anxiety, affecting the frequency of cognitive coping methods negatively. Coping

strategies and low anxiety levels showed improvement in pain reduction and faster rates of improvement in their postoperative condition.

Along with cognitive coping strategies, the effectiveness of music therapy in postoperative pain has been researched. Bradt conducted a study with thirty-two

orthopedic patients ages eight to nineteen years in order to examine the effects of

music therapy on postoperative pain perception in pediatric patients7. Pain perception is "influenced by emotional states and perceived level of control"7. In his study,

participants underwent two levels of music conditions and the control condition for

two consecutive days. The control condition did not have any exposure to music

throughout the duration of the study. Pain questionnaires were answered before and

3

after the experiment in order to measure the increase or decrease in the amount of pain

to determine the effectiveness of the music therapy. His findings concluded that the study supported his hypothesis and music therapy was highly effective as a

postoperative pain management technique for children. More pain was sensed when music was not present, which was proven by the experimental control group. Music

therapy showed increased levels of happiness, peacefulness, relaxation, comfort, and calmness and moderately increased the patient's perceived level of control of pain in

both music conditions, but not in the control condition. Music can be very comforting

and has been shown to relieve muscle tension8.

Like Bradt, Tsao conducted a similar study to that of music therapy, but with

mind distraction affecting long-term pain. Distractions were task-based and her

findings suggested that brief distractions had long-term effects on task-based coping and experimental pain reactivity9. Hendon and Bohon also examined the effects of mood, as negative emotions increase sympathetic stimulation10. Children were observed during play and music therapy in order to measure happiness, defined by

smiles, throughout therapy sessions. Music therapy over play therapy led to more smiles, thus increasing positive moods resulting in beneficial effects in their health and overall experience of pain. Like Hendon and Bohon, Barrera, Rykov and Doyle

conducted a study measuring children's moods and play performance in pre- and post- medical procedures while participating in music therapy sessions11. Outcomes were

measured by children's ratings of feelings on a faces pain scale, and if the child were

under the age of 3, the parent completed the scale. Results concluded significant improvement in ratings of their feelings from pre- and post- music therapy sessions. Another study focusing on pain management with the use of music therapy conducted by Bailey in 1986 concluded music therapy was beneficial. In this study, however, individual moods, needs and skills were assessed prior to therapy sessions,

4

thus providing music therapy based and individual basis. Their goals were directed at achieving a sense of control in order to become more actively involved in managing their own pain. Through individualized music therapy, Bailey concluded music therapy was beneficial when conducted and used as part of a multidisciplinary approach. This approach improved self-esteem and inner well-being leading to physical comfort and inner peace, refocusing their attention away from pain and onto a pleasing sensory experience12.

Nilson provided more encouraging evidence that the amount of pain experienced post-operati vely was significantly reduced by the decrease in use of

morphine in music therapy over the control group, using morphine alone.

obtained data through self reported measures of pain and distress in the preoperative and postoperative period based on a scale of one though ten and the facial affective scale. The self-reports of pain and distress measurements were compared with observations of objective pain scores based on the FLACC scale, vitals signs, and use

Nilson

of pain medication. Children in the music group listened to music for 45 minutes, and

results were compared to the control group. As mentioned previously, music medicine decreased the use of morphine for pain management13. In 2006, Hatem et al. studied pediatric children ages one to sixteen years in the first 24 hours post-operatively follow cardiac surgery while in the pediatric intensive care unit. Their study was a randomized clinical trial assessing heart rate, blood pressure, mean blood pressure, respiratory rate, temperature, oxygen saturation and pain, measured by facial pain score. The absence of music therapy was defined as the placebo. The authors' results concluded listening to music in the intensive care unit was statistically significant in the reduction of heart rate and respiratory rate when compared to those without music therapy14.

5

1.4

DISCUSSION

Post-operative pain in the pediatric population is an inevitable occurrence following any invasive surgical procedure. It has been reported as the most stressful

aspect of hospitalizations.10 Negative emotions directly correlate with children's well-

being and can have a negative impact on prognoses due to the increase in sympathetic stimulation of the nervous system increasing heart rate and blood pressure.10 Unfortunately, as many studies have noted, children commonly base their overall hospital and surgical experience in relation to the level of pain and discomfort they experience and/or perceive. Although more traditional methods of controlling pain with medication are the most common, it may not be the best method for adequate

pain control. If pain is inadequately treated, their perception of medicine is more

negative when compared to those with adequate pain control. These experiences

shape their beliefs and future experiences of not only surgical interventions, but about

the medical field as a whole. Detrimental experiences have a negative impact on

children15, which in turn, may lead to avoiding medical care in the future, regardless of

need. Multiple research studies have provided adequate evidence supporting the

association between pain reduction and use of music therapy.

Research has shown music therapy can supply an additional benefit to pain reduction and possible reduction in the use of pharmaceutical needs.13 Nilson in 2009 focused on reducing the consumption of morphine in children during the post- operative period with the use of music; listening to music rather than involving music

therapists. Through self-report measures, FLACC scale, observations and interviews,

it was concluded there was a significant reduction in morphine use in the post- operative anesthesia care unit in the music group compared to the control group,

where music therapy was not used.13 Listening to music not only reduced the use of

6

morphine, but Nilson noted a reduction in children's distress scores, which may directly correlate with the level of pain each child experienced. In 1986, Bailey suggested music therapy is beneficial in reducing pain when a multidisciplinary approach is used to refocus patient's attention towards a more pleasing experience. It has been suggested if cycles of anxiety and fear, which exacerbate pain, and attention are redirected towards music therapy, then music can assist in enhancing emotional

and physical tension release inducing relaxation and decreasing pain.12 Although

Bailey did not define the patient sample, specific ages or the length of therapy, the study highly suggested music therapy was proven as an adequate mechanism for pain management when tailored to individual needs including physical, psychological and social aspects. The importance of tailoring music to individual needs placed emphasis mainly on the patient's mood and physical abilities providing a more familiar environment. Familiar environments develop a meaningful experience, and techniques with music therapy are devised to help the patient integrate more easily with the overall experience. It was noted that selecting music based on the patient's mood helped the patient to identify and open channels of communication and satisfy the patient. Communication helps facilitate active involvement with music therapy in order to help treat the pain more adequately. With the collaborative efforts between Ae music therapies and the patient, the process results in an improved sense of self-

esteem and well-being, creating physical comfort.12 A more recent study in 2002,

implemented the use of mind distracters in addition to emotional support, to help

decrease post-operative pain.5 Children's pain was measure based on verbal

expression, changes in everyday life, changes in behavior and parents' knowledge of their child through the parents' perception of their child's pain. Although the results of the study showed pain was reduced through distraction mechanisms, and pain was

managed adequately, rater reliability, in this case the parent's rating their child's pain,

7

is not as concrete as a pain scale which can be assessed by an unbiased individual.

In

addition to biased pain measurements, music therapy was not a variable in this study; mind distraction techniques demonstrated adequate pain relief. Pain is an objective experience, and, different from most studies reviewed, it was important to identify pain in order to properly treat the pain. Pain can be expressed in numerous ways, such

as refusing to eat or drink, facial grimaces, crying, tiredness, demand for contact, and a

change in appearance as compared to normal.5 These learned patterns of behavior

may vary based on their parent's cultural understanding of pain which incorporates the

cultural meaning of pain, socioeconomic situation and experience with illness and

possibly observing the child in pain for the first time.5 Many of these factors aid in

the degree to which parental distractions are provided for the child, which supplies a

level of comfort to children. Distractions such as cuddling, entertaining, monitoring

and comforting aid in the reduction of pain.5 Although this study did not specifically

focus on music therapy, we can apply levels of distraction to music therapy, which

also is a form of distraction.

Emotions play an important role in pain reduction, and music therapy

encourages patient participation through exercise, physical activity and moving in a

normal way. This study noted that music has been shown to increase independence in

activities of daily living and restore socialization and emotional well-being.10 Music

therapy also increases children's mood, as it reaches an emotional level more so than other activities. Their study confirmed children smile more in music therapy when

compared to play therapy, which in turn causes a happy experience.10 This study did

not focus on pharmaceutical treatment as a variable, thus making it more difficult to

predict if pain was decreased prior to engaging in music therapy. However, this study

is useful in supporting music therapy as a whole. Smiling, an observation, may

introduce bias and does not have a high predictive value.

8

From these studies, we can infer music therapy does aid in the reduction of

pain, and may be of beneficial value as an adjunct to pharmaceutical measures. As we

have seen, there are numerous ways to use music therapy, and numerous ways to measure pain. Thus, from these studies it is important to define music therapy, and

more concrete ways to measure pain to avoid observer bias, increase rater-reliability, and limit the amount of variables and limitations in a future study.

1.5

CONCLUSION

There is a great deal of research regarding music therapy as a method to reduce

pain in children. The benefits of music therapy alone remain well documented and

prove to stimulate and enhance a child's mood. Mood enhancement is suggestive of reducing the negative experiences, and thus aid in the reduction of pain. Music

therapy not only reduces negative experiences, previous studies also conclude and

support hypotheses that music therapy decreases the level of pain in children when

compared to the control group; non-participants of music therapy. Music therapy

appears to be a well-studied entity; however, many institutions continue to use

traditional methods of controlling pain, such as analgesic use. Traditional methods

appear inadequate at times for the treatment of pain in children, which can be attributed to improper dosing regimens, insufficient and ineffective medications based

on the individual. Side effects to medicine use may also have a negative impact, and although music therapy alone does not change side effects of medications, it may,

however, reduce the use of medications and in turn reduce side effects, while supplying additional pain relief.

Although the evidence discussed supports music therapy as a benefit,

unfortunately, the research is lacking in areas specifically relating pain in children

9

postoperatively and there is minimal research focusing on reducing the use of analgesics for pain when using music therapy as an adjunct to pain management. Future studies examining the use of music therapy as an adjunct to analgesics to

reduce postoperative pain in children are needed to further demonstrate and determine

if music therapy can sufficiently control and reduce pain and the use of analgesics.

10

RESEARCH PROPOSAL

2.1

ABSTRACT

Problem: Children's post-operative pain is a phenomenon that must be described, prevented if and when possible, and relieved to the fullest extent if prevention is not possible. Pain in children is frequently over- or under-diagnosed, thus leading to

improper use of medications resulting in inadequate pain control. Post-operative pain interferes in daily functions, especially sleep, fatigue and helplessness, leading to

increased morbidity and mortality. Lack of pain control directly impacts children emotionally leading to an overall traumatic post-operative experience. Pain

management has been insufficiently studied in children both in the pharmaceutical and

music therapy realm.

Purpose: This study is designed to evaluate the effects of

music therapy compared to analgesic use in pain management in children post- operatively. Research questions: In male and female children ages 5-10 years old

undergoing surgery, will music therapy in addition to analgesic use provide adequate pain control? Will adequate pain control reduce the dosages and usage of analgesics?

Methods: 200 participants, males and females between the ages 5-10 years with acute post-operative pain, will undergo one of two types of treatment. The control group:

will use pharmaceutical means only for pain control, and the experimental group will allow analgesic use plus music therapy. Patients with a history of chronic pain (by self-report), those with central-nervous system, open-heart, or cancer related surgeries will be excluded from participating in the study in order to reduce confounding variable of cognitive deficits and coping with imminent loss of life. Participants will be randomly assigned to the control, or one level of the experimental groups, calling

for 100 patients in each group. Pain assessment will be evaluated over a two-week

11

period on a weekly basis using the Visual Analog Scale to determine which group experiences the least amount of pain dependent on their type of treatment, evaluating

the most effective treatment.

Outcomes: Data will be collected on a daily basis, and

upon completion of the four-day study, overall pain will be re-assessed. Benefit: Data gathered is anticipated to provide further insight into adequate pain control in children in the post-operative setting. This study will help determine if the use of music therapy in addition to analgesic use will control pain management adequately and possibly reduce the use of analgesics when use in conjunction with music therapy.

12

22

AIMS

22.1 Project Overview Children are frequently given medication for postoperative pain based on the

caretaker's perception of such pain16 and pediatric dosing guidelines. Postoperative

pediatric pain relief may be either excessive or inadequate because children's

perception of their pain may be different from their true pain.4 Perceptions are based

on verbal, facial, and body expression or gestures, as well as changes in behavior and

bodily pain.17 "Pain is not only a subjective experience, it is, particularly in children, an emotional issue"18. According to the International Association for the Study of

Pain, pain is defined as "an unpleasant sensory or emotional experience associated

with actual or potential tissue damage, or described in terms of such damage. The inability to communicate verbally does not negate the possibility that an individual is

experiencing pain and is in need of appropriate pain-relieving treatment

unquestionably a sensation in a part or parts of the body, but is also always unpleasant

and therefore also an emotional experience"19.

It is

Unrelieved pain interferes with sleep, leads to fatigue and a sense of

helplessness, and "may result in increased morbidity or mortality"20. Although there is

a concrete definition of pain, as described previously, the degree of pain a child

experiences lacks a true and solid definition. Pain is an instinctive sense, necessary to

the survival of all living beings. Without pain, the perception would go unrecognized and exacerbate to the point of death, and most importantly it is a protective mechanism

essential to survival.

Researchers have explored different modalities to treat post-operative pain; however, there is limited data focusing specifically on music therapy and post- operative pain and whether or not music therapy is an effective treatment for pain

13

reduction in children experiencing post-operative pain. Music therapy, however, has shown therapeutic qualities and has enhanced coping and provided physical and emotional comfort. To further explore pain in children and reduction of pain with the

use of music therapy, we will perform a prospective controlled study comparing music therapy intervention with standard medical analgesia as a control. The specific aims

found below will be used to answer the following questions.

222 Research Questions

1. Is music therapy beneficial in the post-operative period to reduce the level of pain

pediatric patients experience?

2. Will the frequency or the total dosage of analgesics decrease with the use of music therapy to control post-operative pain?

223 Specific Aims

AIM 1: Identify pediatric patients between the ages of 5-10 years, who are undergoing general surgery with the intent to remain hospitalized for approximately five days. AIM 2: Randomly assign subjects to either the control group or the experimental

group.

AIM 3: Compare post-operative pain in the experimental group before and after the

use of analgesics, measured by the visual analog scale. AIM 4: Compare post-operative pain in the experimental group before and after

engaging in music therapy, measured by the visual analog scale.

AIM 5: Compare and analyze the data measured with the visual analog scale using the

Mann-Whitney U test to determine if music therapy is beneficial and if the use of

analgesics was reduced.

14

2.2.4 Hypothesis Children in the experimental group engaging in music therapy in addition to the use of analgesic medications will be more likely to have less and better controlled post-operative pain compared to those using analgesics alone. Administration of both analgesics and music therapy will show the greater amount of pain reduction when

comparing the two groups. This theory directly relates to mind-distracting activities, like music therapy, as these activities will alter the perception of pain, and ultimately

lower their experienced pain when the subjects' focus is elsewhere.

23 BACKGROUND AND SIGNIFICANCE

23.1

Background Music therapy has been in existence and used a therapeutic tool for centuries

across numerous cultures; however, it was not applied clinically until approximately

fifty years ago. In the early 20th century, higher education began to develop medical

education focused around music therapy, although it was yet to be accepted by physicians and music therapists developed this aspect of healing independently. The focus of music therapy is based on a holistic approach to the patient and not merely the chief complaint or the illness and has been defined as "a systematic process of

intervention wherein the therapist helps the client to promote health, using music experiences and the relationships that develop through them as dynamic forces of

change."21 Music as therapy has been known to treat mental health problems even in

notable figures from history and through experimental data it has been suggested the physiological response to music includes enhanced circulation, alterations in blood pressure depending on pitch, intensity and timbre of the music.22

15

Music therapy is included in many departments of integrative medicine, offering mind-body techniques designed to introduce positive thoughts, familiar images, pleasant associations, cheerful memories, peaceful mood, and enjoyable feelings. Listening to music may alone bring about an automatic change in mood. A pleasant memory or association may come to mind immediately and flood the listener

with wonderful thoughts.21,23

"Music therapy is a systematic process of intervention wherein the therapist

helps the client to achieve health, using musical experiences and the relationships that

develop through them as dynamic forces of change.24

Pain is defined as an unpleasant sensory or emotional experience associated with actual or potential tissue damage, or described in terms of such damage, and can

be divided into acute and chronic pain.19 Acute pain is commonly known as "the normal, predicted physiological response to an adverse chemical, thermal or

mechanical stimulus

associated with surgery, trauma and acute illness".25 Although

chronic pain is not addressed in this study it is important to differentiate acute and

chronic pain. Chronic pain is commonly understood as "an unpleasant sense of discomfort that persists or progresses over a long period of time and is often resistant

to medical treatments".26

232 Project Significance There is a great deal of research regarding music therapy as a method to reduce

pain in children. The benefits of music therapy alone remain well documented and proven to stimulate and enhance a child's mood. Mood enhancement is suggestive of reducing the negative experiences, thus aiding in the reduction of pain. Music therapy not only reduces negative experiences, previous studies also conclude and support

hypotheses that music therapy decreases the level of pain in children when compared

to the control group, non-participants of music therapy.

Music therapy appears to be

16

a well-studied entity; however, many institutions continue to use traditional methods

of controlling pain, such as analgesic use. Traditional methods appear inadequate at times for the treatment of pain in children, which can be attributed to improper dosing

regimens, insufficient and ineffective medications based on the individual. Side

effects to medication use may also have a negative impact, and although music therapy alone does not change side effects of medications, it may, however, reduce the use of medications and in turn reduce side effects, and supply additional pain relief. Although the evidence discussed supports music therapy as a benefit, unfortunately, the research is lacking in areas specifically relating to pain in children postoperatively and there is minimal research focusing on reducing the use of analgesics for pain when using music therapy as an adjunct to pain management. Future studies examining the use of music therapy as an adjunct to analgesics to

reduce postoperative pain in children are needed to further demonstrate and determine

if music therapy can sufficiently control and reduce pain and the use of analgesics.

2.4 PRELIMINARY STUDIES

Not applicable

2.5 RESEARCH DESIGN AND METHODS

25.1

Design

It has been well documented that pain in post-operative children is an

inevitable occurrence which influences children's views of the complete operative experience as well as lengthens healing time. Pain traditionally has been treated with

analgesics; however, pain is not always adequately treated. In order to control pain

17

and possibly reduce pain more sufficiently, music therapy has been long studied and implemented in adults. However, there are limited studies showing the efficacy of

music therapy in the post-operative period in children. First, this study will attempt to determine if music therapy in addition to analgesic use will provide adequate pain control in the post-operative period in children between the ages of 5-10 years

undergoing general surgery performed in an open fashion, rather than

laparoscopically. The implementation of music therapy is expected to reduce

analgesic use, thus reducing possible and numerous side effects; according to previous

literature reviews, music therapy has very few side effects.

2.5.2

Methods

Two hundred patients, both male and female, between the ages of 5-10 years who underwent a general surgical procedure will be included in the study. After internal review board approval , children will be selected from the New York metropolitan area. The length of the study will include four days in the post-operative period, as the average length according to the Center for Disease Control in children of this age is

4.5 days27. Exclusion criteria include patients with a history of chronic pain, central

nervous system, open heart or cancer related surgeries, to reduce contamination from cognitive deficits and coping with imminent loss of life. Sex, race, income or socioeconomic status will not be used to select participants. Patients will be randomly

assigned to the control group, analgesic use only, or to the experimental group,

analgesic use plus music therapy; there will be one hundred patients in each group. Consent and instructions will be handed out to parents to sign as all of the actual participants are under the age of eighteen. Consent will explain the voluntary study

and the procedures including medication dosing, which will be used throughout the study. Confidentiality will not be broken, and each participant has the option of withdrawing from the study at any time. Upon completion, debriefing will take place,

18

explaining the reasoning of the study. Contact information for the primary investigator will be provided in case of any problems or questions participants and

consenting parents may have.

Pain will be rated using numerous types of pain rating scales. One in particular is

the Visual Analog Scale, Figure 1.1. The visual analog scale will be used as a self- reported measure of pain, as individual reports are the single most reliable indicator of pain and should be obtained whenever possible. Visual analog scale is based on

rating the pain on a scale of 1-10, ten being the worst pain correlating with smiling

faces to frowning faces.

Very

happy,

no hurt

Hurts just

a little bit

Figure 1.1 Visual Analog Scale

Faces Pain Scale

¦m-

Hurts a

little

more

8 10

Hurts even

Hurts a

Hurts as

more

whole lot

much as

you can

imagine

(don't have

to be crying

to feel Ulis

much pain)

19

2.53 Statistical Analysis A Mann-Whitney U Test with a U value of ? < 0.05 will be conducted. The

two groups, control and experimental group, will consist of one hundred patients randomly assigned to each group. The control group will receive only analgesics every 6 hours on an as-needed basis. The experimental group will receive analgesics every six hours, at the same dose of the control groups dose, as well as music therapy sessions under the supervision of trained music therapists which will occur twice daily

Monday through Friday at 10 am and 6 pm, sixty minutes in duration. Patients will

undergo therapy at the same time and in the same room on a daily basis to ensure reliability. Music therapy sessions will take place for four consecutive days following surgery. Therapy is intended to act as a mind-distracter throughout the day and a sleep aid at night. All 200 children will be given the same sleep schedule in order to ensure

that if sleep acts as a pain alleviator, both group are receiving equal amounts of sleep.

2.5.4

Limitations

Due to the nature of the study, there are limitations beyond control. A double- blinded study is not feasible in this study due to post-operative protocols such as

medication administration and mandatory documentation. Also, with every passing post-operative day, healing is also occurring. Healing is a naturally occurring process resulting in a decrease in pain with time. With a natural decrease in pain, it may be a false result of pain control through music therapy and/or analgesic use. In addition, attrition rate may be a limiting factor. Discharges from the hospital on a daily basis occur as progression in healing and length of stay increases.

Discharges from the hospital prevent further involvement in music therapy, adding an uncontrollable factor in the time each child in the experimental group participates as

an in-patient.

20

Controlling specific analgesie use is a limiting factor as not all children are able to tolerate the same medications. Allergies may also be a factor when

considering medications; however, in order to control for some variability, there will

be a list of medications and conversions in order to ensure dosages and medications are as similar as possible.

2.5.5

Timeline

Pain will be evaluated before analgesic administration and one hour after

analgesic administration as well as before and immediately after music therapy sessions. Each session will last one hour. Pain will be measured using pain measurement scales as discussed previously. Documentation and monitoring will take

place for four consecutive days immediately following surgical procedures.

Each participant and at least one parent or legal guardian must agree to abide

by and follow the assigned regimen throughout the duration of the study. All

medicine being administered will be administered by a licensed professional following pediatric drug dosage guidelines. All participants receiving analgesics will be required to take the same drug, the proper amount according to their weight, and at the

same time to ensure reliability. All dosing will be given on the set schedule for two weeks, pain evaluation done at the end of each week, as well as before and after the study, using the pain measurement scales. Upon completion of the study, pain will again be assessed in order to determine under which condition pain was alleviated most. Data will be recorded and

collected. A difference in the reduction of pain between the groups will measure

success rates.

2.5.6

Conclusion

This study conducted will evaluate 200 participants, 100 in the control group and 100 in the experimental group. Pain assessments will be conducted using the

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visual analog scale. The statistical analysis completed with the Mann-Whitney U test will demonstrate whether music therapy is an adequate form of pain control for

pediatric post-operative patients following general surgery.

2.6

SUMMARY

Children tend to be traumatized to a high degree by experiencing postoperative pain. They are affected both emotionally and physically by both the amount of

experienced pain and the perception of pain. Because analgesics are relied on heavily, it is important to focus and place more emphasis on holistic methods, such as music

therapy. Holistic methods are used as mind distracters and used to treat the whole

person, not just the illness or disease. By engaging in music therapy, children will reduce their intake of pain medication and learn to cope with and manage their own

pain. Pain medications can cause numerous side effects; however, if intake is reduced

or eliminated, side effects will also be reduced or eliminated.

Through this proposed experiment, we would be able to determine if music

therapy as an adjunct to analgesic use results in adequate pain control, and whether or not the use of analgesics will be decreased when engaging in music therapy. The pain would be self-reported and measured by the Visual Analog Scale, and documented.

The evaluated results would determine whether or not the experimental group was impacted by alternative therapy. If the impact was great enough, it will be suggestive that pediatric patients undergo music therapy in order to reduce postoperative pain more sufficiently. This would include training children's hospitals and caretakers how to implement the music therapy into the child's life in the post-operative setting.

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