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Effect of Music Therapy on Families of Burn Patients (MTS3)

This study has been terminated.
(Music therapist left position.)
Sponsor:
Collaborators:
The Cleveland Music School Settlement
Kulas Foundation
Information provided by:
MetroHealth Medical Center
ClinicalTrials.gov Identifier:
NCT00824681
First received: January 15, 2009
Last updated: July 22, 2010
Last verified: July 2010
History of Changes
  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 1

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

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Burns
U.S. FDA Resources

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
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
Active Comparator: 2
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

Locations
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
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: Xueli Tan, The Cleveland Music School Settlement
ClinicalTrials.gov Identifier: NCT00824681     History of Changes
Other Study ID Numbers: 06-00891
Study First Received: January 15, 2009
Last Updated: July 22, 2010
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

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013