BurnsPhase 1MTS3NCT00824681
Effect of Music Therapy on Families of Burn Patients
A Phase 1 study testing Sound Of Family Together (S.O.F.T.) Music Program and Non-Therapy Related Activities (NTRA) in people with Burns, run by MetroHealth Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Burns
- What is being tested?
- Sound Of Family Together (S.O.F.T.) Music Program and Non-Therapy Related Activities (NTRA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Jul 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Burns
- Being tested
- Sound Of Family Together (S.O.F.T.) Music Program, Non-Therapy Related Activities (NTRA)
- 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
- Medical subject headings
- Burns, Anxiety Disorders, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sound Of Family Together (S.O.F.T.) Music ProgramBehavioural
Audio compact disk containing songs, music, special messages, poems from children of adults with major burns
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Sound Of Family Together (S.O.F.T.) Music Program Receives: Behavioral: Sound Of Family Together (S.O.F.T.) Music Program |
| 2 | Active comparator | Non-Therapy Related Activities (NTRA) Receives: Other: Non-Therapy Related Activities (NTRA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety level
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2009 (estimated)
- Study startSep 2007
- Primary completionJul 2010
- Study completionJul 2010
Why it stopped: Music therapist left position.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Music School Settlement, Kulas Foundation
- Investigators
- Xueli Tan, MM, MT-BC, Study chair, The Cleveland Music School SettlementCharles J Yowler, MD, FACS, Principal investigator, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824681
- Sponsor's protocol ID
- 06-00891
- Acronym
- MTS3
- Status last verified
- Jul 2010
- First submitted
- 15 Jan 2009
- Last updated
- 23 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00824681
- Acronym / sponsor ID
- MTS3 / 06-00891
- Conditions
- Burns
- Keywords
- Psychological adjustment of family, family of patients, children of patients, intensive care unit, burn, music therapy, music, music program
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Music therapist left position.
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Collaborators
- The Cleveland Music School Settlement, Kulas Foundation
- Study start
- Sep 2007
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 19 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Sound Of Family Together (S.O.F.T.) Music ProgramSound Of Family Together (S.O.F.T.) Music Program |
| 2 | Active comparator | Other: Non-Therapy Related Activities (NTRA)Non-Therapy Related Activities (NTRA) |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sound Of Family Together (S.O.F.T.) Music ProgramAudio compact disk containing songs, music, special messages, poems from children of adults with major burns | Behavioural | 1 |
| 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. | Other | 2 |
Primary outcome
Anxiety level
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Music therapist left position.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xueli Tan, MM, MT-BC study chair
The Cleveland Music School Settlement
Charles J Yowler, MD, FACS principal investigator
MetroHealth Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sound Of Family Together (S.O.F.T.) Music Program and Non-Therapy Related Activities (NTRA) in people with Burns, run by MetroHealth Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Music therapist left position.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety level (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2010.