Effect of Music Therapy on Families of Burn Patients - Full Text View

Sponsors and Collaborators:	MetroHealth Medical Center The Cleveland Music School Settlement Kulas Foundation
Information provided by:	MetroHealth Medical Center
ClinicalTrials.gov Identifier:	NCT00824681

Purpose

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.

Condition	Intervention	Phase
Burns	Behavioral: Sound Of Family Together (S.O.F.T.) Music Program Other: Non-Therapy Related Activities (NTRA)	Phase I

MedlinePlus related topics: Anxiety Burns

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Crossover Assignment, Efficacy Study
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

Further study details as provided by MetroHealth Medical Center:

Primary Outcome Measures:

Anxiety level [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Sound Of Family Together (S.O.F.T.) Music Program	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
2: Active Comparator Non-Therapy Related Activities (NTRA)	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.

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

Ages Eligible for Study:	6 Years to 14 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00824681

Contacts

Contact: Xueli Tan, MM,MT-BC	(216) 778-4683	xtan@metrohealth.org
Contact: Charles J Yowler, MD, FACS	(216) 778-5627	cyowler@metrohealth.org

Locations

United States, Ohio
MetroHealth Medical Center	Recruiting
Cleveland, Ohio, United States, 44109
Contact: Xueli Tan, MM,MT-BC 216-778-4683 xtan@metrohealth.org
Contact: Charles J Yowler, MD, FACS (216) 778-5627 cyowler@metrohealth.org
Principal Investigator: Charles J Yowler, MD, FACS
Sub-Investigator: Xueli Tan, MM, MT-BC
Sub-Investigator: Richard B Fratianne, MD, FACS
Sub-Investigator: Trisha Remark, BA, CCLS
Sub-Investigator: Thomas Swales, PhD

Sponsors and Collaborators

MetroHealth Medical Center

The Cleveland Music School Settlement

Kulas Foundation

Investigators

Study Chair:	Xueli Tan, MM, MT-BC	The Cleveland Music School Settlement
Principal Investigator:	Charles J Yowler, MD, FACS	MetroHealth Medical Center

More Information

No publications provided

Responsible Party:	The Cleveland Music School Settlement ( Xueli Tan )
Study ID Numbers:	06-00891
Study First Received:	January 15, 2009
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00824681 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by MetroHealth Medical Center:

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

Study placed in the following topic categories:

Burns
Wounds and Injuries
Disorders of Environmental Origin

Additional relevant MeSH terms:

Burns
Wounds and Injuries
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on May 07, 2009