Effect of Music Therapy on Families of Burn Patients

Burns Clinical Trial

— MTS3  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00824681
• Other study ID #: 06-00891
• Status: Terminated
• Phase: Phase 1
• First received: January 15, 2009
• Last updated: July 22, 2010
• Start date: September 2007
• Est. completion date: July 2010

Study information

• Verified date: July 2010
• Source: MetroHealth Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 14 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Burns

Intervention

Behavioral:
• 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

Other:
• 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.

Locations

Country	Name	City	State
United States	MetroHealth Medical Center	Cleveland	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
MetroHealth Medical Center	Kulas Foundation, The Cleveland Music School Settlement

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety level		1 year	No