Efficacy of Music Therapy Protocols for Burn Debridement

NCT ID: NCT00822497

Last Updated: 2010-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2010-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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1

Music-Based Imagery

Group Type EXPERIMENTAL

Music-Based Imagery (MBI)

Intervention Type BEHAVIORAL

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

2

Music Alternate Engagement

Group Type EXPERIMENTAL

Music Alternate Engagement (MAE)

Intervention Type 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.

Control

Debridement under standard care with no music therapy interventions

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Music & Imagery Distraction Technique

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Music School Settlement

OTHER

Sponsor Role collaborator

Kulas Foundation

OTHER

Sponsor Role collaborator

MetroHealth Medical Center

OTHER

Sponsor Role lead

Responsible Party

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The Cleveland Music School Settlement

Principal Investigators

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Xueli Tan, MM, MT-BC

Role: STUDY_CHAIR

The Cleveland Music School Settlement

Richard B. Fratianne, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

MetroHealth Medical Center

Locations

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MetroHealth Medical Center

Cleveland, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 11227691 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11227684 (View on PubMed)

Other Identifiers

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99-00147

Identifier Type: -

Identifier Source: org_study_id

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