Efficacy of Music Therapy Protocols for Burn Debridement

Phase 1

Completed

• Conditions: Pain Management
• Interventions: Behavioral: Music-Based Imagery (MBI); Behavioral: Music Alternate Engagement (MAE)

• Registration Number: NCT00822497
• Lead Sponsor: MetroHealth Medical Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2009-01-13
• Study First Submitted QC: 2009-01-13
• Study First Posted: 2009-01-14
• Status Verified: 2010-07
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Last Update Submitted: 2010-07-22
• Last Update Posted: 2010-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Music-Based Imagery (MBI)	Music-Based Imagery
2	Music Alternate Engagement (MAE)	Music Alternate Engagement

Primary Outcome Measures

Name	Time	Method
Pain, Anxiety, Muscle Tension levels	7 data points before, during, after debridement

Secondary Outcome Measures

Name	Time	Method
Narcotics & Anxiolytics (dosage)	Throughout debridement process

Trial Locations

Locations (1)

MetroHealth Medical Center; 🇺🇸 Cleveland, Ohio, United States