Pre-operative Stress Reduction With Music

Study Overview
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Brief Summary
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The purpose of this study is to assess the effect of music, played prior to a surgical procedure, on stress levels during induction of anesthesia. Hypothesis: playing calming music, pre-selected by the investigator and the patient, beginning just prior to induction and terminating after induction will positively reduce the patient's heart rate, blood pressure, and respiratory rate during this period. For this study, noise-cancelling headphones with the ability to play music via an iPod will be utilized.

Detailed Description
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Reduced stress and relaxation positively contribute to patient healing after surgery (1). Reduction of stress associated with surgery is even more important in children, for whom a traumatic experience can have even more damaging and long-lasting effects (2). One stress-reduction technique of current interest is music. In global studies outside of the surgical realm, music has been shown to reduce heart rate, blood pressure, respiratory rate, and stress hormone levels as well as alleviate anxiety (3). Evidence has also been found that listening to music pre-operatively in both adult and pediatric cases can reduce patients' stress and anxiety levels before surgery (3,7) Of the studies that have addressed the benefits of pre-operative music, however, none have assessed the impact of pre-operative music on stress levels during induction. In addition, almost all prior studies of the benefits of perioperative music have assessed the effect of only one style of music on each patient group. This set-up is beneficial in eliminating variables within the study design, but it fails to consider the individuality of each patient and what he/she might find to be relaxing. This study aims to assess the effect of music (selected by the pediatric patient from one of several pre-compiled playlists) played pre-operatively and during induction on patient stress levels.

Official Title
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The Effect of Music on Pre-operative Stress in Pediatric Orthopedic Patients

Conditions
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Pediatric Pre-operative Stress

Intervention / Treatment
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* Other: Relaxing Music
* Other: No Music


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 10 - 16 years Present to the OR for correction of an orthopedic complaint not involving the head or neck Consent to participate in the study obtained from both the guardian and child Patients and guardians are English-speaking Exclusion Criteria: Hearing impairments or ear abnormalities Pre-existing issues with substance abuse, anxiety, or depression Pre-existing psychiatric disorders

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Relaxing Music<br>Participants will listen to relaxing music through noise-cancelling headphones during induction. | Other: Relaxing Music<br>* Relaxing music, will be played through noise-cancelling headphones during induction of anesthesia. All of the songs used in this study will have <60 BPM, be instrumental rather than lyrical, and utilize predictable chord progressions. Music will be divided into several themed playlists which will be focused on the type of instruments involved including guitar, steel drum, and piano. The patient will listen to the music through noise-cancelling headphones beginning fifteen minutes prior to induction and ending one minute after intubation.<br>|
| Active Comparator: No Music<br>Participants will wear noise-cancelling headphones during induction but no music will be played through them. | Other: No Music<br>* The patient will wear noise-cancelling headphones beginning fifteen minutes prior to induction and ending one minute after intubation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Heart Rate from baseline recorded when the headphones are placed on the patient |  | 15 minutes after headphones are applied, at arrival in the operating room, during induction, during intubation, and one minute after intubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Blood Pressure from baseline recorded when the headphones are placed on the patient |  | 15 minutes after headphones are applied, at arrival in the operating room, during induction, during intubation, and one minute after intubation | 
| Change in Respiratory Rate from baseline recorded when the headphones are placed on the patient |  | 15 minutes after headphones are applied, at arrival in the operating room, during induction, during intubation, and one minute after intubation |