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

27 Dec 2018

The date of last modification

Mar 03, 2019



Application Summary


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


Trial Details


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

  1. This trial will be done at the Rheumatology and Rehabilitation Hospital (RRH)– Ragama Sri lanka

  2. Patients will be divided into 2 groups using the Block Randomized design.

  3. 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.

  4. 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.

  5. 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)

1.

Functional Independence Measurement score

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Before, in 5 weeks and the end of 10 weeks of music therapy.

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Secondary outcome(s)

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

Recruiting


Funding source

None (Investigator funded)


Regulatory approvals

Not applicable



State of Ethics Review Approval


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 & Sponsor Information


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

Secondary study sponsor (If any)

None





Trial Completion details


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