Home » Trials » SLCTR/2018/041
A randomized controlled trial on Impact of music therapy on the functional improvement of patients with traumatic brain injuries at the Rheumatology and Rehabilitation Hospital - Ragama
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SLCTR Registration Number
SLCTR/2018/041
Date of Registration
The date of last modification
Dec 01, 2021
Trial Status
Scientific Title of Trial
A randomized controlled trial on Impact of music therapy on the functional improvement of patients with traumatic brain injuries at the Rheumatology and Rehabilitation Hospital - Ragama
Public Title of Trial
Effect of music therapy for patients with brain damage due to accidents
Disease or Health Condition(s) Studied
Traumatic brain injury
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1223-0454
Any other number(s) assigned to the trial and issuing authority
ERC Ref. No: P/132/07/2018
What is the research question being addressed?
What is the impact of music therapy on the functional improvement of patients with traumatic brain injuries?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Supportive care
Study Phase
Not Applicable
Intervention(s) planned
This trial will be done at the Rheumatology and Rehabilitation Hospital (RRH)– Ragama Sri lanka
Patients will be divided into 2 groups using the Block Randomized design.
Patients will be taken to a quiet room along with the bystanders, with a maximum of four patients at one time. A recorded music track will be played and the patients will be allowed to listen while they would be encouraged to participate actively according to their disability either by singing, clapping, whistling, head nodding, or by moving his/her hands or feet. With the music, the investigator will be actively participating and motivating patient’s family members/ bystanders to encourage the patients to participate. This will be done on a one to one basis by four investigators daily under the supervision of the supervisor, ie 20 minutes during 12.00 noon to 2.00 pm and in the evening which are the other rehabilitation therapy free hours on week days. This will be done for 10 weeks for one patient.
Other standard care including medical management and rehabilitation therapies; physiotherapy, occupational therapy and speech therapy will be given to both the intervention group and the control group during routine therapy hours.
FIM score prior to therapy, during (at 5 weeks of therapy) and after completion (10 weeks of therapy) will be assessed by senior registrars in Rheumatology and Rehabilitation and they will be blinded to the intervention.
Inclusion criteria
Patients who are admitted with traumatic brain injuries to the Rheumatology and Rehabilitation Hospital – Ragama, during this study period.
Exclusion criteria
Patients who are admitted with a history of non- traumatic brain injuries to the Rheumatology and Rehabilitation Hospital – Ragama, during this study period will be excluded. Also patients who were diagnosed with hearing defects either before or after the head trauma will be excluded
Primary outcome(s)
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1.
Functional Independence Measurement score |
[ Before, in 5 weeks and the end of 10 weeks of music therapy. ] |
Secondary outcome(s)
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1.
None |
[ None ] |
Target number/sample size
30
Countries of recruitment
Sri Lanka
Anticipated start date
2019-01-01
Anticipated end date
2019-12-01
Date of first enrollment
2019-01-01
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
None (Investigator funded)
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2018-10-16
Approval number
P/132/07/2018
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. V.S.T. Nelunika
MO- Nutrition
Rheumatology and Rehabilitation Hospital- Ragama, Sri Lanka
Tel: 011-2958294
Mob: 071- 8098186
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thilanki.0830@gmail.com
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Contact Person for Public Queries
Dr. Duminda Munidasa
Consultant in Rheumatology & Rehabilitation
Rheumatology and Rehabilitation Hospital, Ragama, Sri Lanka
Tel: 011-2958212
Mob: 077- 7910369
Fax: 011-2959181
duminda.eresha@gmail.com
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Primary study sponsor/organization
Rheumatology and Rehabilitation Hospital- Ragama
Rheumatology and Rehabilitation Hospital- Ragama, Sri Lanka
011-2958294
011-2959181
info@rrh.health.gov.lk
www.rrh.health.gov.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
