| CTRI Number |
CTRI/2025/03/083586 [Registered on: 27/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Yoga on Cognition, cardiac autonomic function and mental health parameters among female students with elevated stress |
|
Scientific Title of Study
|
Effect of Yoga on cognitive functions, mental health and Heart rate variability (HRV) among female students with elevated stress: A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kashinath G Metri |
| Designation |
Assistant Professor |
| Affiliation |
central university of rajasthan |
| Address |
Department of yoga, Central university of Rajasthan, NH-8 Bandarsindari
Ajmer
RAJASTHAN
305817
India |
| Phone |
9035257626 |
| Fax |
|
| Email |
kashinath@curaj.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Juhi Kumawat |
| Designation |
Research scholar |
| Affiliation |
central university of rajasthan |
| Address |
Department of yoga, Central university of Rajasthan, NH-8 Bandarsindari
19, Hari nagar 5, swej farm sodala, jaipur- 302019
Ajmer
RAJASTHAN
305817
India |
| Phone |
9782809445 |
| Fax |
|
| Email |
juhii.16kumawat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kashinath G Metri |
| Designation |
Assistant Professor |
| Affiliation |
central university of rajasthan |
| Address |
Department of yoga, Central university of Rajasthan, NH-8 Bandarsindari
Ajmer
RAJASTHAN
305817
India |
| Phone |
9035257626 |
| Fax |
|
| Email |
kashinath@curaj.ac.in |
|
|
Source of Monetary or Material Support
|
| Central University of Rajasthan, NH 8, Bandarsindari, Ajmer, Rajasthan, India-305817 |
|
|
Primary Sponsor
|
| Name |
Kashinath G Metri |
| Address |
Department of yoga, Central university of Rajasthan, NH-8, Bandarsindari, Ajmer-305817, Rajasthan |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Kashinath G Metri |
Central University of Rajasthan |
Faculty room no. 1 (Sri Aurobindo kaksa), Department of Yoga, Central university of Rajasthan, NH-8, Bandarsindari, Ajmer, Rajasthan -305817
Ajmer
RAJASTHAN |
9035257626
kashinath@curaj.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Institutional Ethics Committee, Central University of Rajasthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Elevated stress |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Waitlist Control |
Participants in this group will follow there daily routine activities. |
| Intervention |
Yoga Therapy |
A validated yoga module will be utilized as the core treatment protocol. This module is already standardized and published. a 60-minute yoga module, 4 times in a week for 8 weeks will be given; the yoga module consists of asanas, pranayama, meditation, and relaxation techniques. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
(1) Consented female student having PSS score more than 14,
(2) Who have basic computer knowledge
(3) age between 18-25 years
(4) who can read and write in English language
|
|
| ExclusionCriteria |
| Details |
(1) Females who are having physical or mental chronic health issues
(2) previous exposure to yoga in the last 3 months
(3) any form of addiction
(4) married
(5) on long term medication for any reason or on sleep medication
(6) recently undergone major surgery in the last one year
(7) involved in any form of regular physical activity/sports/yoga/ meditation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
(1) Cognitive Functions: working memory, selective attention and response inhibition, sustained attention, problem solving and planning, processing speed and cognitive flexibility. All cognitive assessment will be taken through a free and open software PEBL.
(2) Mental Health:
Perceived stress: Perceived Stress Scale (PSS10)
Anxiety and depression: Hospital Anxiety and Depression Scale (HADS)
Sleep quality: Pittsburgh Sleep Quality Index (PSQI)
Fatigue: Fatigue Assessment Scale (FAS)
Coping: Brief COPE
Test anxiety: Westside Test Anxiety Scale
(3) Heart Rate Variability: HRV will be derived using BIOPAC Student Lab. Participant’s ECG will be taken.
|
All assessments will be performed at baseline and after 8 weeks.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood Pressure, Body mass index |
All assessments will be performed at baseline (0 week) and after 8 weeks.
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/04/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study examines the effects of yoga on cognitive functions, mental health, and heart rate variability (HRV) among female university students experiencing elevated stress. Stress is prevalent in this demographic, with significant adverse effects on academic performance, cognitive abilities, and overall well-being. Yoga, as a holistic practice involving physical postures, breathing exercises, and meditation, is recognized for its stress-reducing and cognitive-enhancing benefits.
The randomized controlled trial involves 60 participants divided into an intervention group receiving yoga sessions and a control group. The intervention includes 60-minute yoga sessions conducted four times weekly for eight weeks. Outcomes will be measured using validated tests for working memory, attention, stress, anxiety, sleep quality, and HRV.
The study aims to provide evidence-based insights into yoga’s role in managing stress and enhancing mental health and cognitive performance. Its findings could inform non-pharmacological interventions to support female students in coping with academic and daily life challenges, ultimately improving their quality of life and academic success. By addressing the unique stressors faced by this group, the research highlights yoga’s potential as a practical tool for stress management and holistic wellness. |