Home » Trials » SLCTR/2018/002
Effectiveness of a yoga based intervention package on behavior problems among grade eight school children in Jaffna district, Sri Lanka.
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SLCTR Registration Number
SLCTR/2018/002
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
Effectiveness of a yoga based intervention package on behavior problems among grade eight school children in Jaffna district, Sri Lanka.
Public Title of Trial
Student behavior intervention study
Disease or Health Condition(s) Studied
Student behavior change with yoga based intervention
Scientific Acronym
None
Public Acronym
None
Brief title
The effectiveness of yoga based intervention on the behavior of grade 8 school children
Universal Trial Number
U 1111 - 1205 - 0415
Any other number(s) assigned to the trial and issuing authority
P/127/08/2017 (ERC: Kelaniya)
What is the research question being addressed?
Is yoga-based intervention effective in changing the behavior of grade 8 school children?
Type of study
Interventional
Study design
Allocation
Non-randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Prevention
Study Phase
Not Applicable
Intervention(s) planned
Study settings: Class 1AB, 1C, Class 11 Government schools in the Jaffna district, Sri Lanka.
This is a Quasi experimental study. Out of 5 education zones in Jaffna, 2 will be selected (non random) for trial and 2 will be selected as control zones. Within the zones selection of schools will be population proportion to size by random number allocation online software applied to the online list of schools by Northern education ministry. Trial is not randomised, but sample (schools) is randomly selected. Interventions:
The intervention will be carried out in the first 15 minutes during the keep fit time from Monday to Thursday each week for 2 terms (24 weeks).
The intervention will be delivered by certified YOGA instructors for the first 2 weeks, and by student leaders under the supervision of the class teacher/physical education teacher for a total of 24 weeks.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Improvement in student behavior as determined by 1. Strength and difficulty questionnaire (SDQ) student form 2. SDQ teacher form 3. SDQ parent form |
[ At baseline and 24 weeks after the commencement of the intervention. ] |
Secondary outcome(s)
|
1.
Improvement in school subject marks |
[ At baseline and 24 weeks after the commencement of the intervention. ] |
Target number/sample size
1500 (750 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2018-02-01
Anticipated end date
2018-08-02
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None (Investigator funded)
Regulatory approvals
Status
Approved
Date of Approval
2017-09-12
Approval number
P/127/08/2017
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 J.T. Sivashankar
Registrar, Community Medicine
Dept. Community Medicine, University of Jaffna under the Postgraduate Institute of Medicine
University of Colombo, Sri Lanka
tel: 0212218178
Mob: 0771547590
Fax: 0212222073
dcfmjaffna@gmail.com
www.med.jfn.ac.lk
Contact Person for Public Queries
Dr Rajendra Surenthirakumaran,
Consultant Community Physician and Senior Lecturer
Dept. Community and Family Medicine,
University of Jaffna,
Aadiyapatham Road
Kokuvil, Jaffna
Sri Lanka
0212218178
Mob: 0777448080
0212222073
surenthirakumaran@gmail.com
www.med.jfn.ac.lk
Primary study sponsor/organization
Dept. Community and Family Medicine, University of Jaffna
Aadiyapatham Road
Kokuvil, Jaffna
Sri Lanka
Tel: 0212218178
Fax: 0212222073
dcfmjaffna@gmail.com
http://www.med.jfn.ac.lk/index.php/community-medicine/
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
