- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00824681
Effect of Music Therapy on Families of Burn Patients (MTS3)
July 22, 2010 updated by: MetroHealth Medical Center
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
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 Overview
Status
Terminated
Conditions
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 Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44109
- MetroHealth Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 14 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
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
|
ACTIVE_COMPARATOR: 2
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Anxiety level
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Charles J Yowler, MD, FACS, MetroHealth Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (ACTUAL)
July 1, 2010
Study Completion (ACTUAL)
July 1, 2010
Study Registration Dates
First Submitted
January 15, 2009
First Submitted That Met QC Criteria
January 15, 2009
First Posted (ESTIMATE)
January 19, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
July 23, 2010
Last Update Submitted That Met QC Criteria
July 22, 2010
Last Verified
July 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-00891
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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