Slctr

A randomized controlled trial of the customized music therapies (MTs) in the reduction of morbidities on non-communicable diseases, at both clinical levels (improving glycemic control and blood pressure control) and molecular biological or pathogenetic level (transcriptomics).

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SLCTR Registration Number

SLCTR/2021/012

Date of Registration

22 Apr 2021

The date of last modification

Apr 24, 2021

Application Summary

Scientific Title of Trial

A randomized controlled trial of the customized music therapies (MTs) in the reduction of morbidities on non-communicable diseases, at both clinical levels (improving glycemic control and blood pressure control) and molecular biological or pathogenetic level (transcriptomics).

Public Title of Trial

Effects of music therapy with standard care, in contrast to standards care only, in improving diabetes in adults with diabetes mellitus attending clinic at National Hospital of Sri Lanka

Disease or Health Condition(s) Studied

Type 2 diabetes mellitus

Scientific Acronym

None

Public Acronym

None.

Brief title

Effect of customized music therapies in diabetes

Universal Trial Number

U1111-1264-4602

Any other number(s) assigned to the trial and issuing authority

EC 20-010

Trial Details

What is the research question being addressed?

What is the effect of customized music therapy on glycemic control, blood pressure control and underlying transcriptomics in patients with established diabetes mellitus?

Type of study

Interventional

Study design

Allocation

Randomized controlled trial

Masking

Masking not used : Participants

Control

Standard therapy/practice

Assignment

Parallel

Purpose

Treatment

Study Phase

Not Applicable

Intervention(s) planned

Study setting: NHSL Colombo, General Medicine Clinic. Method of randomization: Stratified block randomization will be used to divide the participants in to the music therapy intervention group and the control group and stratification will be conducted considering age groups, as 40% from the age category of patients who are less than 60 years of age and 60% from the age category of patients who are more than 60 years of age. Intervention: The patients selected for the music therapy intervention will be asked to listen to each of the customized music therapy tracks for three minutes each, and mark in a visual analogue scale how relaxed they felt while listening to each type of music. The tracks identified as having a high relaxation effect will be prescribed as his/her treatment. The intervention group patients will be provided with a MP3 player each with headphones free of charge. They will be requested to listen to the prescribed music, uninterrupted for 30 minutes, every day. They will be provided a diary to mark the duration they spent listening as well as keep a note of the days they failed to do so. Research assistants would telephone the patients once a week and attend the clinic on the days the patient would come and record the clinical observations and biochemical test results. The control group will have ‘usual care’ with no request to spend any amount of time seated in a place. Duration of intervention: The intervention will continue for one year.

Inclusion criteria

• Adults (Age range from 18 years to 75 years) • both genders • with type 2 diabetes attending a general medicine clinic, • HbA1c value 7.5% or higher

Exclusion criteria

• Hearing impairment • Cognitive impairment

Primary outcome(s)

Number of participants with a reduction of HbA1c by at least 0.5 from baseline levels.

[
0 months, 3 months, 6 months, 9 months, 12 months following Music Therapy (MT)
]

Secondary outcome(s)

1. Change in mean scores of PHQ9 questionnaire which measures perceived stress and depression. .	[ 0 months, 3 months, 6 months, 9 months, 12 months following MT ]
2. Change in mean blood pressure.	[ 0 months, 3 months, 6 months, 9 months, 12 months following MT ]
3. Significant changes in relative expressions of miRNAs related to type 2 diabetes mellitus	[ 0 months, 6 months, 12 months following MT ]
4. Identify miRNA markers related to type 2 diabetes mellitus.	[ 0 months,6 months,12 months following MT ]
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Target number/sample size

320 (160 in each arm)

Countries of recruitment

Sri Lanka

Anticipated start date

2021-04-26

Anticipated end date

2022-05-27

Date of first enrollment

Date of study completion

Recruitment status

Pending

Funding source

The World Bank funded research grant, AHEAD/DOR/STEM+HEMS No.78 under the “Development-Oriented Research” scheme of the “Accelerating Higher Education and Expansion (AHEAD)” project.

Regulatory approvals

State of Ethics Review Approval

Status

Approved

Date of Approval

2020-08-20

Approval number

EC-20-010

Details of Ethics Review Committee

Name:	Ethics review Committee, Faculty of Medicine, University of Colombo.
Institutional Address:	P O Box 271, Kynsey Road, Colombo 8, Sri Lanka
Telephone:	+94112695300
Email:	ethicscommitteemfc@gmail.com

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Dr.W.K.R.R Dias
Senior Lecturer
Department of North Indian Music, Faculty of Music, University of Visual and Performing Arts.
0812395833
+9475-3544320
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rangeethdias@gmail.com
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Contact Person for Public Queries

Dr. P Karunanayake
Specialist physician for the Professorial Unit in Medicine, National Hospital of Sri Lanka
Office: 4th floor, Clinical Medicine Academic and Research Centre (ClinMARC), National Hospital of Sri Lanka, Colombo 8
+94 112 695 300
+94 772 787 754
+94 112 689 188
panduka@clinmed.cmb.ac.lk
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Primary study sponsor/organization

AHEAD Operations, World Bank
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6th Floor, Hilton Colombo 2, Chittampalam A. Gardiner Mawatha Colombo 2, Sri Lanka
+94-11 5561300

infosrilanka@worldbank.org
https://ahead.lk/

Secondary study sponsor (If any)

Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

IPD sharing plan description

Study protocol available

Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available

Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results