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Efficacy of Music Therapy Protocols for Burn Debridement (MTS1)

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ClinicalTrials.gov Identifier: NCT00822497
Recruitment Status : Completed
First Posted : January 14, 2009
Last Update Posted : July 23, 2010
The Cleveland Music School Settlement
Kulas Foundation
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Pain Management Behavioral: Music-Based Imagery (MBI) Behavioral: Music Alternate Engagement (MAE) Phase 1

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Efficacy of Music Therapy Protocols for Decreasing Pain, Anxiety, and Muscle Tension Levels During Burn Debridement: A Prospective Randomized Crossover Trial
Study Start Date : October 2004
Primary Completion Date : July 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Burns
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Music-Based Imagery
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.
Other Name: Music & Imagery
Experimental: 2
Music Alternate Engagement
Behavioral: 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.
Other Name: Distraction Technique
No Intervention: Control
Debridement under standard care with no music therapy interventions

Primary Outcome Measures :
  1. Pain, Anxiety, Muscle Tension levels [ Time Frame: 7 data points before, during, after debridement ]

Secondary Outcome Measures :
  1. Narcotics & Anxiolytics (dosage) [ Time Frame: Throughout debridement process ]

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00822497

United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Sponsors and Collaborators
MetroHealth Medical Center
The Cleveland Music School Settlement
Kulas Foundation
Study Chair: Xueli Tan, MM, MT-BC The Cleveland Music School Settlement
Principal Investigator: Richard B. Fratianne, MD, FACS MetroHealth Medical Center