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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

January 13, 2009
July 22, 2010
October 2004
July 2010   (final data collection date for primary outcome measure)
Pain, Anxiety, Muscle Tension levels [ Time Frame: 7 data points before, during, after debridement ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00822497 on ClinicalTrials.gov Archive Site
Narcotics & Anxiolytics (dosage) [ Time Frame: Throughout debridement process ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy of Music Therapy Protocols for Burn Debridement
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Pain Management
  • 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
  • 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
  • Experimental: 1
    Music-Based Imagery
    Intervention: Behavioral: Music-Based Imagery (MBI)
  • Experimental: 2
    Music Alternate Engagement
    Intervention: Behavioral: Music Alternate Engagement (MAE)
  • No Intervention: Control
    Debridement under standard care with no music therapy interventions

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
July 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
7 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00822497
99-00147
No
Xueli Tan, MM, MT-BC, The Cleveland Music School Settlement
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
MetroHealth Medical Center
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP