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

MetroHealth Medical Center logo

MetroHealth Medical Center

Status and phase

Terminated
Phase 1

Conditions

Burns

Treatments

Other: Non-Therapy Related Activities (NTRA)
Behavioral: Sound Of Family Together (S.O.F.T.) Music Program

Study type

Interventional

Funder types

Other

Identifiers

NCT00824681
06-00891

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

6 to 14 years old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

30 participants in 2 patient groups

1
Experimental group
Description:
Sound Of Family Together (S.O.F.T.) Music Program
Treatment:
Behavioral: Sound Of Family Together (S.O.F.T.) Music Program
2
Active Comparator group
Description:
Non-Therapy Related Activities (NTRA)
Treatment:
Other: Non-Therapy Related Activities (NTRA)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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