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

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ClinicalTrials.gov Identifier: NCT00824681
Recruitment Status : Terminated (Music therapist left position.)
First Posted : January 19, 2009
Last Update Posted : July 23, 2010
Sponsor:
Collaborators:
The Cleveland Music School Settlement
Kulas Foundation
Information provided by:
MetroHealth Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Burns Behavioral: Sound Of Family Together (S.O.F.T.) Music Program Other: Non-Therapy Related Activities (NTRA) Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : September 2007
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Burns

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Anxiety level [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00824681


Locations
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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
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Study Chair: Xueli Tan, MM, MT-BC The Cleveland Music School Settlement
Principal Investigator: Charles J Yowler, MD, FACS MetroHealth Medical Center
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Xueli Tan, The Cleveland Music School Settlement
ClinicalTrials.gov Identifier: NCT00824681    
Other Study ID Numbers: 06-00891
First Posted: January 19, 2009    Key Record Dates
Last Update Posted: July 23, 2010
Last Verified: July 2010
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:
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Burns
Wounds and Injuries