PDF of Trial CTRI Website URL - http://ctri.nic.in

Clinical Trial Details (PDF Generation Date :- Sat, 25 Sep 2021 01:05:26 GMT)

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 COVID-19 Pandemic- Impact of tele yoga on mental health and quality of life in adolescents Study Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Vikas Rawat Trial Coordinator (multi-center study) 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 Phone 6362805583 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Vikas Rawat Query) 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 [email protected] Details Contact Details Contact Person (Public Query) 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

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Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > SVYASA Yoga University, Bengaluru Primary Sponsor Primary Sponsor Details Name Arun Thulasi Address Vadakkethil House, Kumplampoika P.O., Pathanamthtitta, - 689661 Type of Sponsor Other [Self-Funded] Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Arun Thulasi Secondary & Higher Government Secondary 9497762866 secondary schools, School, Kumplampoika, Kerala Pathanamthtitta, Kerala [email protected] KERALA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Institution Ethics Approved 13/01/2021 No Committee, SVYASA, Bengaluru Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Healthy Human Volunteers Mental Health and Quality of Life Intervention / Type Name Details Comparator Agent 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. 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. Inclusion Criteria 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 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

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Exclusion Criteria Exclusion Criteria 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 Coin toss, Lottery, toss of dice, shuffling cards etc Random Sequence Method of Not Applicable Concealment Blinding/Masking Not Applicable Primary Outcome Outcome Timepoints 1.To conduct a survey to assess the mental Strengths and Difficulties Questionnaire health and Health related Quality Of Life Time-point: 8 and 12 weeks (HRQOL) in school children and its implications WHOQOL-BREF Time-point: 8 and 12 weeks 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 Secondary Outcome Outcome Timepoints 1.To assess the efficacy of self-practice of tele Well-being of Children in Lockdown Scale yoga for mental health and Health related Quality (WCLS) Time Point: 8 weeks and 12 weeks 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 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 11/03/2021 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 Trial Months=4 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Open to Recruitment Trial (India) Publication Details None 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

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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).

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