Clinical trial NCT00824681: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Burns
Keywords: 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
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
Collaborators: name: The Cleveland Music School Settlement
name: Kulas Foundation
First posted: 2009-01-19
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Anxiety level
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
Study officials:
affiliation: The Cleveland Music School Settlement
name: Xueli Tan, MM, MT-BC
role: STUDY_CHAIR
affiliation: MetroHealth Medical Center
name: Charles J Yowler, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: