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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 15, 2009
First Posted Date  ICMJE January 19, 2009
Last Update Posted Date July 23, 2010
Study Start Date  ICMJE September 2007
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2009)
Anxiety level [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Music Therapy on Families of Burn Patients
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Burns
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • Experimental: 1
    Sound Of Family Together (S.O.F.T.) Music Program
    Intervention: Behavioral: Sound Of Family Together (S.O.F.T.) Music Program
  • Active Comparator: 2
    Non-Therapy Related Activities (NTRA)
    Intervention: Other: Non-Therapy Related Activities (NTRA)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: January 15, 2009)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00824681
Other Study ID Numbers  ICMJE 06-00891
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xueli Tan, The Cleveland Music School Settlement
Study Sponsor  ICMJE MetroHealth Medical Center
Collaborators  ICMJE
  • The Cleveland Music School Settlement
  • Kulas Foundation
Investigators  ICMJE
Study Chair: Xueli Tan, MM, MT-BC The Cleveland Music School Settlement
Principal Investigator: Charles J Yowler, MD, FACS MetroHealth Medical Center
PRS Account MetroHealth Medical Center
Verification Date July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP