| CTRI Number |
CTRI/2021/02/031543 [Registered on: 25/02/2021] Trial Registered Prospectively |
| Last Modified On: |
11/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
COVID-19 Pandemic- Impact of online yoga on mental health and quality of life in adolescents |
|
Scientific Title of Study
|
COVID-19 Pandemic- Impact of tele yoga on mental health and quality of life in adolescents |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vikas Rawat |
| Designation |
Associate Professor |
| Affiliation |
Swami Vivekananda Yoga Anusandhana Samsthana |
| Address |
Division of Yoga & Humanities,
SVYASA Yoga University,
Swami Vivekananda Road, Kalluballu Post,
Anekal, Jigani,
Karnataka
Bangalore
KARNATAKA
560105
India |
| Phone |
6362805583 |
| Fax |
|
| Email |
vikasrawat.svyasa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vikas Rawat |
| Designation |
Associate Professor |
| Affiliation |
Swami Vivekananda Yoga Anusandhana Samsthana |
| Address |
Division of Yoga & Humanities,
SVYASA Yoga University,
Swami Vivekananda Road, Kalluballu Post,
Anekal, Jigani,
Karnataka
Bangalore
KARNATAKA
560105
India |
| Phone |
6362805583 |
| Fax |
|
| Email |
vikasrawat.svyasa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vikas Rawat |
| Designation |
Associate Professor |
| Affiliation |
Swami Vivekananda Yoga Anusandhana Samsthana |
| Address |
Division of Yoga & Humanities,
SVYASA Yoga University,
Swami Vivekananda Road, Kalluballu Post,
Anekal, Jigani,
Karnataka
Bangalore
KARNATAKA
560105
India |
| Phone |
6362805583 |
| Fax |
|
| Email |
vikasrawat.svyasa@gmail.com |
|
|
Source of Monetary or Material Support
|
| SVYASA Yoga University, Bengaluru |
|
|
Primary Sponsor
|
| Name |
Arun Thulasi |
| Address |
Vadakkethil House,
Kumplampoika P.O.,
Pathanamthtitta, Kerala- 689661 |
| Type of Sponsor |
Other [Self-Funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Arun Thulasi |
Secondary & Higher secondary schools, Kerala |
Government Secondary School, Kumplampoika, Pathanamthtitta, Kerala
Pathanamthitta
KERALA |
9497762866
arunthulli@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee, SVYASA, Bengaluru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mental Health and Quality of Life |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Online Physical Exercises |
Standard physical exercises will be provided to the control group comprising of routine exercises and games that can be done at home. |
| Intervention |
Tele Yoga |
Online yoga would be taught to school children in the intervention group that would consist of practices like loosening practices, Surya Namaskara, Asanas, Pranayama and relaxation. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. School children between the age group of 12-18 years
2. Children fluent in English or Malayalam languages
3. Both males and females
4. Children & parents consenting to participate in the study
5. Children having access to a smartphone or electronic device with internet connectivity
|
|
| ExclusionCriteria |
| Details |
1.Children with ongoing acute illness or those with a history of chronic illness in the preceding six months
2.Children with visual, hearing & speech disabilities
3.Children practicing yoga or any other similar practices while staying at home during the last 3 months
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To conduct a survey to assess the mental health and Health related Quality Of Life (HRQOL) in school children and its implications on parents in Kerala due to the current COVID-19 home confinement
2.To assess the efficacy of tele yoga for mental health and Health Related Quality Of Life (HRQOL) in school children during home confinement |
Strengths and Difficulties Questionnaire Time-point: 8 and 12 weeks
WHOQOL-BREF Time-point: 8 and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess the efficacy of self-practice of tele yoga for mental health and Health related Quality Of Life (HRQOL) in school children during home confinement
2.To assess the efficacy of self-practice of tele yoga for mental health and Health related Quality Of Life (HRQOL) in school children soon after joining school
3.To assess parental response of implication of tele yoga on school children |
Well-being of Children in Lockdown Scale (WCLS) Time Point: 8 weeks and 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/03/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is to assess the mental health and health-related quality of life in schoolchildren from secondary and senior secondary schools in Kerala during the COVID-19 pandemic through an online survey. Selected school children from the survey would be randomly assigned into the intervention group (tele yoga) and control group (online physical practices) for a period of 2 months and 1 month follow-up period. The primary outcome measures will be Mental Health and Quality of life measured using the Strengths & Difficulties questionnaire & WHOQOL-BREF respectively at 3-time points: before the intervention, 2 months after the intervention & 1 month after follow-up. The secondary outcome measures will be the assessment of the efficacy of the tele yoga program on school children (questionnaire) and parental response (using Well-being of School Children in Lockdown Scale). |