Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
30 participants
INTERVENTIONAL
2007-09-30
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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1
Sound Of Family Together (S.O.F.T.) Music Program
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
Non-Therapy Related Activities (NTRA)
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.
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Years
14 Years
ALL
No
Sponsors
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The Cleveland Music School Settlement
OTHER
Kulas Foundation
OTHER
MetroHealth Medical Center
OTHER
Responsible Party
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The Cleveland Music School Settlement
Principal Investigators
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Xueli Tan, MM, MT-BC
Role: STUDY_CHAIR
The Cleveland Music School Settlement
Charles J Yowler, MD, FACS
Role: PRINCIPAL_INVESTIGATOR
MetroHealth Medical Center
Locations
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MetroHealth Medical Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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06-00891
Identifier Type: -
Identifier Source: org_study_id
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