Efficacy of Music Therapy Protocols for Burn Debridement

Pain Management Clinical Trial

— MTS1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00822497
• Other study ID #: 99-00147
• Status: Completed
• Phase: Phase 1
• First received: January 13, 2009
• Last updated: July 22, 2010
• Start date: October 2004
• Est. completion date: July 2010

Study information

• Verified date: July 2010
• Source: MetroHealth Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain Management

Intervention

Behavioral:
• Music-Based Imagery (MBI)
MBI is form of music-assisted relaxation with imagery. This protocol is used at the patients' bedside before and after the debridement process.
• Music Alternate Engagement (MAE)
MAE consisted of a menu of music therapy interventions aimed at engaging the patients in music and diverting them away from the debridement process.

Locations

Country	Name	City	State
United States	MetroHealth Medical Center	Cleveland	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
MetroHealth Medical Center	Kulas Foundation, The Cleveland Music School Settlement

Country where clinical trial is conducted

United States, 

References & Publications (2)

Fratianne RB, Prensner JD, Huston MJ, Super DM, Yowler CJ, Standley JM. The effect of music-based imagery and musical alternate engagement on the burn debridement process. J Burn Care Rehabil. 2001 Jan-Feb;22(1):47-53. — View Citation

Prensner JD, Yowler CJ, Smith LF, Steele AL, Fratianne RB. Music therapy for assistance with pain and anxiety management in burn treatment. J Burn Care Rehabil. 2001 Jan-Feb;22(1):83-8; discussion 82-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain, Anxiety, Muscle Tension levels		7 data points before, during, after debridement	No
Secondary	Narcotics & Anxiolytics (dosage)		Throughout debridement process	No