Efficacy of Music Therapy Protocols for Burn Debridement (MTS1)

July 22, 2010 updated by: MetroHealth Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Distraction Technique
No Intervention: Control
Debridement under standard care with no music therapy interventions

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Narcotics & Anxiolytics (dosage)
Time Frame: Throughout debridement process
Throughout debridement process

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MetroHealth Medical Center

Collaborators

The Cleveland Music School Settlement
Kulas Foundation

Investigators

  • Principal Investigator: Richard B. Fratianne, MD, FACS, MetroHealth Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

January 13, 2009

First Submitted That Met QC Criteria

January 13, 2009

First Posted (Estimate)

January 14, 2009

Study Record Updates

Last Update Posted (Estimate)

July 23, 2010

Last Update Submitted That Met QC Criteria

July 22, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 99-00147

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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