Efficacy of Music Therapy Protocols for Burn Debridement

NCT00822497 | Completed Phase 1

• 1 other identifier: 99-00147
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Management

Keywords

music therapy; pain; anxiety; muscle tension

Outcome Measures

Primary Outcomes (1)

• Pain, Anxiety, Muscle Tension levels

  7 data points before, during, after debridement

Secondary Outcomes (1)

• Narcotics & Anxiolytics (dosage)

  Throughout debridement process

Study Arms (3)

1

EXPERIMENTAL

Music-Based Imagery

Behavioral: Music-Based Imagery (MBI)

2

EXPERIMENTAL

Music Alternate Engagement

Behavioral: Music Alternate Engagement (MAE)

Control

NO INTERVENTION

Debridement under standard care with no music therapy interventions

Interventions

Music-Based Imagery (MBI) BEHAVIORAL

MBI is form of music-assisted relaxation with imagery. This protocol is used at the patients' bedside before and after the debridement process.

Also known as: Music & Imagery

1

Music Alternate Engagement (MAE) BEHAVIORAL

MAE consisted of a menu of music therapy interventions aimed at engaging the patients in music and diverting them away from the debridement process.

Also known as: Distraction Technique

2

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MetroHealth Medical Center: lead
• The Cleveland Music School Settlement: collaborator
• Kulas Foundation: collaborator

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Related Publications (2)

• 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. doi: 10.1097/00004630-200101000-00019.

  PMID: 11227691 BACKGROUND

• 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. doi: 10.1097/00004630-200101000-00010.

  PMID: 11227684 BACKGROUND

MeSH Terms

Conditions

Agnosia; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Xueli Tan, MM, MT-BC

  The Cleveland Music School Settlement

  STUDY CHAIR

• Richard B. Fratianne, MD, FACS

  MetroHealth Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 13, 2009
• First Posted: January 14, 2009
• Study Start: October 1, 2004
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: July 23, 2010

Record last verified: 2010-07

Locations

US (1)