Expired Study
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Cleveland, Ohio 44109


Purpose:

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.


Study summary:

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.


Criteria:

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


Study is Available At:


Original ID:

06-00891


NCT ID:

NCT00824681


Secondary ID:


Study Acronym:

MTS3


Brief Title:

Effect of Music Therapy on Families of Burn Patients


Official Title:

Sound Of Family Together (S.O.F.T.) Music Program: A Randomized-Controlled Study to Investigate the Effect of Music Therapy on the Coping and Adjustment of Children of Adults With Major Burns


Overall Status:

Terminated


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

6 Years


Maximum Age:

14 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

MetroHealth Medical Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Music therapist left position.


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

30


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Xueli Tan, MM, MT-BC
Study Chair
The Cleveland Music School Settlement

Study Dates

Start Date:September 2007
Completion Date:July 2010
Completion Type:Actual
Primary Completion Date:July 2010
Primary Completion Type:Actual
Verification Date:July 2010
Last Changed Date:July 22, 2010
First Received Date:January 15, 2009

Study Outcomes

Outcome Type:Primary Outcome
Measure:Anxiety level
Time Frame:1 year
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Sound Of Family Together (S.O.F.T.) Music Program
Description:Audio compact disk containing songs, music, special messages, poems from children of adults with major burns
Arm Name:1
Intervention Type:Other
Name:Non-Therapy Related Activities (NTRA)
Description: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.
Arm Name:2

Study Arms

Study Arm Type:Active Comparator
Arm Name:2
Description:Non-Therapy Related Activities (NTRA)
Study Arm Type:Experimental
Arm Name:1
Description:Sound Of Family Together (S.O.F.T.) Music Program

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:MetroHealth Medical Center
Agency Class:Other
Agency Type:Collaborator
Agency Name:The Cleveland Music School Settlement

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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