Home » Trials » SLCTR/2019/026
Effectiveness of receptive music medicine on short term symptomatic relief of Sri Lankan patients with mild to moderate depression.
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SLCTR Registration Number
SLCTR/2019/026
Date of Registration
The date of last modification
Sep 15, 2020
Scientific Title of Trial
Effectiveness of receptive music medicine on short term symptomatic relief of Sri Lankan patients with mild to moderate depression.
Public Title of Trial
Randomized controlled trial on the effectiveness of receptive music on short term symptomatic relief of Sri Lankan patients with mild to moderate depression
Disease or Health Condition(s) Studied
Mild to moderate depression
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1230-7148
Any other number(s) assigned to the trial and issuing authority
What is the research question being addressed?
Is receptive music medicine and standard care more effective than standard care alone on short term symptomatic relief of depression in Sri Lankan patients with mild to moderate depression
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded : Investigators, Healthcare providers
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 3
Intervention(s) planned
Study will be done in the out-patient psychiatry clinic at National Hospital Sri Lanka. Patients will be randomized using “online research randomizer” by an outsider. The intervention group will receive locally developed music in addition to the standard treatment. This music is created within a multi-disciplinary core group including professional musicians and medical professionals. The trial will be conducted for four weeks. Participants will be informed to listen to the given music twice a day; 15 minutes in the morning and 15 minutes in the evening, for three days a week. Music will be delivered using compact disks, tape records or through mobile phones according to the patient preference. The control group will receive only the standard treatment which includes pharmacological treatment and counselling
Inclusion criteria
1.Male and female patients aged 18-65 years 2.Sri Lankan by nationality 3.Patients newly diagnosed with mild to moderate depression using ICD-10 criteria on the first visit
Exclusion criteria
1.Patients with severe depression and several other psychiatric co-morbidities. 2. Patients with amusia or tone deafness tested using tone deaf test at the time of sample collection. 3.Known patients with complete deafness. 4.Patients with hearing problems tested using whisper test. 5.Patients attending clinic for the follow up visits. 6.Patients who do not have any devices such as mobile phones, CD players, computers etc., to listen to the music medicine. 7.Patients with severe depression and other psychiatric co-morbidities
Primary outcome(s)
|
1.
Improvement in Beck Depression Inventory (available in three languages) will be used to assess. Score will be marked pre and post interventional, in both arms. |
[ At the beginning of the intervention and end of 4 weeks (after the intervention). ] |
Secondary outcome(s)
|
1.
To compose a locally developed music medicine which is cross cultural and motivational using a core group of medical and music professionals. |
[ 2 months after the intervention ] |
Target number/sample size
60 (30 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2019-08-19
Anticipated end date
2019-09-18
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2019-01-23
Approval number
CSRP/19/021
Details of Ethics Review Committee
| Name: | Ethics review committee of faculty of medicine, university of Colombo |
| Institutional Address: | Ethics review committee, Faculty of medicine, University of Colombo, Kynsey Road, Colombo 08. |
| Telephone: | +94112695300 ext 240 |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
H.M.S.A. Herath
Undergraduate student
Faculty of medicine,
University of Colombo,
Kynsey Road,
Colombo 08
+94714654960
sanjayaherathg@gmail.com
Contact Person for Public Queries
Professor Saroj Jayasinghe
Chair Professor of Medicine
Faculty of medicine, University of Colombo, Kynsey Road, Colombo 08
0718619331
sarojoffice@yahoo.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
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
