Effect of Music Therapy on Families of Burn Patients

Phase 1

Terminated

• Conditions: Burns
• Interventions: Behavioral: Sound Of Family Together (S.O.F.T.) Music Program; Other: Non-Therapy Related Activities (NTRA)

• Registration Number: NCT00824681
• Lead Sponsor: MetroHealth Medical Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2009-01-15
• Study First Submitted QC: 2009-01-15
• Study First Posted: 2009-01-19
• Status Verified: 2010-07
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Last Update Submitted: 2010-07-22
• Last Update Posted: 2010-07-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Sound Of Family Together (S.O.F.T.) Music Program	Sound Of Family Together (S.O.F.T.) Music Program
2	Non-Therapy Related Activities (NTRA)	Non-Therapy Related Activities (NTRA)

Primary Outcome Measures

Name	Time	Method
Anxiety level	1 year

Trial Locations

Locations (1)

MetroHealth Medical Center; 🇺🇸 Cleveland, Ohio, United States