Effect of Music Therapy on Families of Burn Patients

Study Overview
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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.

Official Title
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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

Conditions
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Burns

Intervention / Treatment
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* Behavioral: Sound Of Family Together (S.O.F.T.) Music Program
* Other: Non-Therapy Related Activities (NTRA)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Sound Of Family Together (S.O.F.T.) Music Program | Behavioral: Sound Of Family Together (S.O.F.T.) Music Program<br>* Audio compact disk containing songs, music, special messages, poems from children of adults with major burns<br>|
| Active Comparator: 2<br>Non-Therapy Related Activities (NTRA) | Other: Non-Therapy Related Activities (NTRA)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety level |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychological adjustment of family, family of patients, children of patients, intensive care unit, burn, music therapy, music, music program, anxiety, coping, adjustment, psychological stressor, emotional stressor