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Completed

NCT Number: NCT00822497

Efficacy of Music Therapy Protocols for Burn Debridement

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.

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Key information

Age range

7 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Music & Imagery

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.

Other names: Distraction Technique

Primary outcomes

  1. Pain, Anxiety, Muscle Tension levels

    Time frame: 7 data points before, during, after debridement

Secondary outcomes

  1. Narcotics & Anxiolytics (dosage)

    Time frame: Throughout debridement process

Sponsors and collaborators

Lead sponsor

MetroHealth Medical Center

Other

Collaborators

  • Kulas Foundation
  • The Cleveland Music School Settlement

Registry information

Official study title

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

Acronym: MTS1

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Jan 14, 2009
Registry last updated
Jul 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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