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Efficacy of Music Therapy Protocols for Burn Debridement (MTS1)

This study has been completed.
Sponsor:
Collaborators:
The Cleveland Music School Settlement
Kulas Foundation
Information provided by:
MetroHealth Medical Center
ClinicalTrials.gov Identifier:
NCT00822497
First received: January 13, 2009
Last updated: July 22, 2010
Last verified: July 2010
History of Changes
  Purpose

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 Intervention Phase
Pain Management
 Behavioral: Music-Based Imagery (MBI)
Behavioral: Music Alternate Engagement (MAE)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:

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

Further study details as provided by MetroHealth Medical Center:

Primary Outcome Measures:
  • Pain, Anxiety, Muscle Tension levels [ Time Frame: 7 data points before, during, after debridement ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Narcotics & Anxiolytics (dosage) [ Time Frame: Throughout debridement process ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2004
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00822497

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

Publications:

Responsible Party: Xueli Tan, MM, MT-BC, The Cleveland Music School Settlement
ClinicalTrials.gov Identifier: NCT00822497     History of Changes
Other Study ID Numbers: 99-00147
Study First Received: January 13, 2009
Last Updated: July 22, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by MetroHealth Medical Center:
music therapy
pain
anxiety
muscle tension

ClinicalTrials.gov processed this record on May 21, 2013