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

07 Aug 2019

The date of last modification

Oct 14, 2019



Application Summary


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


Trial Details


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.

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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.

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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



State of Ethics Review Approval


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 & Sponsor Information


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


Primary study sponsor/organization







Secondary study sponsor (If any)







Trial Completion details


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