Efficacy of Music Therapy Protocols for Burn Debridement

Study Overview
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Brief Summary
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The purpose of this prospective, crossover randomized study is to explore the efficacy of two music therapy protocols on pain, anxiety, and muscle tension levels throughout the debridement process in individuals hospitalized with moderate to severe burns.

Detailed Description
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The study is a prospective, randomized crossover clinical trial conducted on a 14-bed inpatient comprehensive burn care center. The purpose of this study is to investigate the efficacy of Music-Based Imagery (MBI) and Music Alternate Engagement (MAE) for pain and anxiety management for burn patients throughout the debridement process.

Official Title
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The Efficacy of Music Therapy Protocols for Decreasing Pain, Anxiety, and Muscle Tension Levels During Burn Debridement: A Prospective Randomized Crossover Trial

Conditions
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Pain Management

Intervention / Treatment
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* Behavioral: Music-Based Imagery (MBI)
* Behavioral: Music Alternate Engagement (MAE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is admitted for at least three days (excluding day of admission) Patient is at least seven years old Patient is able to communicate, i.e. awake and alert Patient is oriented Exclusion Criteria: Patient admitted for/less than three days Patient under seven years of age Patient not able to communicate, i.e. sedated and/or intubated Patient is not oriented, i.e. active psychosis, hallucinations, delusions, late-stage Alzheimer's or dementia diagnoses

Ages Eligible for Study
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Minimum Age: 7 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Music-Based Imagery | Behavioral: Music-Based Imagery (MBI)<br>* MBI is form of music-assisted relaxation with imagery. This protocol is used at the patients' bedside before and after the debridement process.<br>* Other names: Music & Imagery;|
| Experimental: 2<br>Music Alternate Engagement | Behavioral: Music Alternate Engagement (MAE)<br>* MAE consisted of a menu of music therapy interventions aimed at engaging the patients in music and diverting them away from the debridement process.<br>* Other names: Distraction Technique;|
| No Intervention: Control<br>Debridement under standard care with no music therapy interventions | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain, Anxiety, Muscle Tension levels |  | 7 data points before, during, after debridement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Narcotics & Anxiolytics (dosage) |  | Throughout debridement process | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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music therapy, pain, anxiety, muscle tension