Effect of Music Therapy on Families of Burn Patients

NCT ID: NCT00824681

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

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2010-07-31

Brief Summary

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The purpose of this study is to investigate the efficacy of music therapy in assisting with the coping and adjustment of children of adults with major burns. The investigators hypothesized that there will be a significant decrease in anxiety levels between those children who participated in music therapy compared to non-participants.

Detailed Description

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The Sound Of Family Together (S.O.F.T.) Music Program was introduced on a 14-bed burn intensive care unit to provide an avenue for communication between adults with major burns and their children. In adherence with unit policies, children under the age of 16 are only allowed onto the unit under very special circumstances, e.g. patient is under DNR status. This restriction may translate into a prolong absence between the patients and their young children; which may result in emotional and psychological stress factors such as separation anxiety, feelings of abandonment, and rejection of the parent when the patient is being discharged to home. Children who participate in the S.O.F.T. Music Program will record and produce an audio CD for their hospitalized parent/grandparent. The contents of the CD might include original songs, poems, and special messages created by the children. Pre and post tests results will determine the efficacy of the program to decrease anxiety levels in the children.

Conditions

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Burns

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

Sound Of Family Together (S.O.F.T.) Music Program

Group Type EXPERIMENTAL

Sound Of Family Together (S.O.F.T.) Music Program

Intervention Type BEHAVIORAL

Audio compact disk containing songs, music, special messages, poems from children of adults with major burns

2

Non-Therapy Related Activities (NTRA)

Group Type ACTIVE_COMPARATOR

Non-Therapy Related Activities (NTRA)

Intervention Type OTHER

NTRA includes non-directed activities e.g. reading books/magazines, watching TV/movie in family lounge off the BICU, playing with toys, listening to music CDs/radio.

Interventions

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Sound Of Family Together (S.O.F.T.) Music Program

Audio compact disk containing songs, music, special messages, poems from children of adults with major burns

Intervention Type BEHAVIORAL

Non-Therapy Related Activities (NTRA)

NTRA includes non-directed activities e.g. reading books/magazines, watching TV/movie in family lounge off the BICU, playing with toys, listening to music CDs/radio.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Child's age between 6 - 14 years
* Child or grandchild of patient
* Child with limited visitation
* Adequate hearing, with correction
* Consenting non-hospitalized adult family member (NHAFM) speak/read English
* Child speak/read English
* Major physical or mental illness or disability does not interfere with ability to communicate for both consenting NHAFM and child

Exclusion Criteria

* Child's age below 6 years and above 14 years
* Not the child or grandchild of patient
* Child with unlimited visitation
* Hearing loss that interferes with ability to communicate
* NHAFM does not speak/read English
* Child does not speak/read English
* Major physical or mental illness or disability interferes with ability to communicate for both consenting NHAFM and child
* Patient on observation status, i.e. only one overnight stay
Minimum Eligible Age

6 Years

Maximum Eligible Age

14 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

Charles J Yowler, 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

Other Identifiers

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06-00891

Identifier Type: -

Identifier Source: org_study_id

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