Effect of Music Therapy on Families of Burn Patients

NCT00824681 | Terminated Phase 1

• 1 other identifier: 06-00891
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Anxiety level

  1 year

Study Arms (2)

1

EXPERIMENTAL

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

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

2

ACTIVE COMPARATOR

Non-Therapy Related Activities (NTRA)

Other: Non-Therapy Related Activities (NTRA)

Interventions

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

Audio compact disk containing songs, music, special messages, poems from children of adults with major burns

1

Non-Therapy Related Activities (NTRA) OTHER

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.

2

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MetroHealth Medical Center: lead
• The Cleveland Music School Settlement: collaborator
• Kulas Foundation: collaborator

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

MeSH Terms

Conditions

Burns; Anxiety Disorders; Stress, Psychological

Condition Hierarchy (Ancestors)

Wounds and Injuries; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Xueli Tan, MM, MT-BC

  The Cleveland Music School Settlement

  STUDY CHAIR

• Charles J Yowler, MD, FACS

  MetroHealth Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 15, 2009
• First Posted: January 19, 2009
• Study Start: September 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: July 23, 2010

Record last verified: 2010-07

Locations

US (1)