search
Back to results

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

Primary Purpose

Burns

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sound Of Family Together (S.O.F.T.) Music Program
Non-Therapy Related Activities (NTRA)
Sponsored by
MetroHealth Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Burns focused on measuring 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

Eligibility Criteria

6 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MetroHealth Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Sound Of Family Together (S.O.F.T.) Music Program

Non-Therapy Related Activities (NTRA)

Outcomes

Primary Outcome Measures

Anxiety level

Secondary Outcome Measures

Full Information

First Posted
January 15, 2009
Last Updated
July 22, 2010
Sponsor
MetroHealth Medical Center
Collaborators
The Cleveland Music School Settlement, Kulas Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT00824681
Brief Title
Effect of Music Therapy on Families of Burn Patients
Acronym
MTS3
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 Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Terminated
Why Stopped
Music therapist left position.
Study Start Date
September 2007 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
MetroHealth Medical Center
Collaborators
The Cleveland Music School Settlement, Kulas Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Sound Of Family Together (S.O.F.T.) Music Program
Arm Title
2
Arm Type
Active Comparator
Arm Description
Non-Therapy Related Activities (NTRA)
Intervention Type
Behavioral
Intervention Name(s)
Sound Of Family Together (S.O.F.T.) Music Program
Intervention Description
Audio compact disk containing songs, music, special messages, poems from children of adults with major burns
Intervention Type
Other
Intervention Name(s)
Non-Therapy Related Activities (NTRA)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Anxiety level
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xueli Tan, MM, MT-BC
Organizational Affiliation
The Cleveland Music School Settlement
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Charles J Yowler, MD, FACS
Organizational Affiliation
MetroHealth Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Effect of Music Therapy on Families of Burn Patients

We'll reach out to this number within 24 hrs