| CTRI Number |
CTRI/2026/03/106071 [Registered on: 12/03/2026] Trial Registered Prospectively |
| Last Modified On: |
11/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Yoga Practice on Stress, Anxiety, and Sleep Quality among Adolescents (16–19 years) in a University. |
|
Scientific Title of Study
|
Effect of Common Yoga Protocol on Stress, Anxiety, and Sleep Quality among Adolescent students (16-19 Years) in a University of Haryana: An Interventional Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Alok |
| Designation |
Assistant Professor |
| Affiliation |
SGT University Gurugram |
| Address |
B Block, Room no 207
Department of Community Medicine FMHS SGT University Budhera Gurugram haryana
B Block, Room no 207
Department of Community Medicine FMHS SGT University Budhera Gurugram haryana
Gurgaon
HARYANA
122505
India |
| Phone |
8858425866 |
| Fax |
|
| Email |
alokiiphd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nandini Sharma |
| Designation |
Professor & HOD |
| Affiliation |
SGT University Gurugram |
| Address |
B Block, Room no 208
Department of Community Medicine FMHS SGT University Budhera Gurugram haryana
B Block, Room no 208
Department of Community Medicine FMHS SGT University Budhera Gurugram haryana
Gurgaon
HARYANA
122505
India |
| Phone |
9968604245 |
| Fax |
|
| Email |
hod.community@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
Alok |
| Designation |
Assistant Professor |
| Affiliation |
SGT University Gurugram |
| Address |
B Block, Room no 207
Department of Community Medicine FMHS SGT University Budhera Gurugram haryana
B Block, Room no 207
Department of Community Medicine FMHS SGT University Budhera Gurugram haryana
Gurgaon
HARYANA
122505
India |
| Phone |
8858425866 |
| Fax |
|
| Email |
alokiiphd@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SGT University |
| Address |
B Block, Room no 207
SGT University Budhera Gurugram Haryana India 122505 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Alok |
SGT University |
Yoga Lab Room no 302
Department of Physiology FMHS SGT University
Gurgaon
HARYANA |
8858425866
alokiiphd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| FACULTY OF MEDICINE & HEALTH SCIENCES, SGT UNIVERSITY INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Apparently Healthy Adolescents |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Common Yoga Protocol |
Common Yoga Protocol (CYP) is a standardised yoga protocol released by the Ministry of AYUSH, India, for International Yoga Day. (Figure I ) It consists of sets of structured invocations, loosening exercises, Yoga Asanas, Pranayamas, Meditation, and affirmations for a duration of 45 minutes. A 1-day sensitisation session was conducted before the intervention began, during which the protocol was explained in depth to the participants. Two certified yoga trainers from the faculty of Naturopathy and Yogic Science of the University conducted the CYP sessions between 9 am to 10 am in the morning. The duration of the supervised intervention, i.e. the CYP, was 40–45 minutes three times per week for 12 weeks If any official holiday fell on the intervention day, it was held on the subsequent working day. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Both |
| Details |
All medical and paramedical Adolescent students enrolled in the institute during the specified period ( April 2026- May 2027) were willing to participate. |
|
| ExclusionCriteria |
| Details |
a. Adolescent students who were absent for more than three consecutive days during the data collection period.
b. Adolescent students on psychiatric treatment or psychotherapy for Mental Disorders like PTSD and addiction.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Anxiety
Stress
Sleep Quality
Serum Cortisol |
at Week 12 and 24 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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)
|
01/04/2026 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Title: Effect of Common Yoga Protocol on Stress, Anxiety, and Sleep Quality among Adolescent students (16-19 Years) in a University of Haryana: An Interventional Study
Background and Rationale
Adolescence is a critical developmental stage characterized by rapid physical, psychological, and social changes. Increasing academic pressure, lifestyle changes, and psychosocial stressors have contributed to a rising prevalence of stress, anxiety, and sleep disturbances among adolescents. Poor mental health during this period can negatively affect academic performance, emotional well-being, and long-term health outcomes.
Yoga is a holistic mind–body practice that combines physical postures, breathing techniques, relaxation, and meditation. The Common Yoga Protocol (CYP) developed by the Ministry of AYUSH, Government of India, provides a standardized yoga module designed to promote physical and mental well-being. Previous studies have suggested that yoga may help reduce stress, improve emotional regulation, and enhance sleep quality. However, limited prospective research has evaluated the impact of a structured yoga protocol among adolescent students.
Therefore, this study aims to assess the effectiveness of the Common Yoga Protocol in improving stress levels, anxiety symptoms, and sleep quality among adolescents aged 16–19 years.
Aim
To evaluate the effect of the Common Yoga Protocol on stress, anxiety, and sleep quality among adolescent students aged 16–19 years.
Objectives
Primary Objective
To determine the effect of the Common Yoga Protocol on stress, anxiety, and sleep quality among adolescents at baseline and after completion of the intervention.
Secondary Objective
To assess changes in physiological stress response through the measurement of serum cortisol levels among a subset of participants before and after the intervention.
Study Design
Prospective interventional study.
Study Setting
The study will be conducted among adolescent students aged 16–19 years in selected educational institutions.
Study Population
Adolescent students aged between 16–19 years who are enrolled in the selected institutions and are willing to participate in the study.
Sample Size
A total of 220 participants will be included in the study. The sample size has been calculated using statistical power analysis considering an expected moderate effect size, 95% confidence level, and adequate statistical power.
Inclusion Criteria
* Students aged 16–19 years.
* Students willing to participate in the study.
* Students who provide written informed consent (and parental consent where applicable).
Exclusion Criteria
* Students undergoing treatment for severe psychiatric disorders.
* Students with medical conditions that contraindicate participation in yoga practice.
* Students unwilling to participate or unable to attend the intervention sessions.
Study Intervention
Participants will undergo the Common Yoga Protocol (CYP), a standardized yoga module developed by the Ministry of AYUSH.
The intervention will include:
* Loosening exercises
* Yoga asanas (postures)
* Pranayama (breathing practices)
* Meditation and relaxation techniques
Each session will last approximately 40–45 minutes and will be conducted three times per week for 12 weeks under the supervision of certified yoga instructors.
Data Collection
Data will be collected using validated standardized questionnaires and biological assessment.
Psychological Assessment Tools
* Perceived Stress Scale (PSS-10) – to assess stress levels
* Generalized Anxiety Disorder Scale (GAD-7) – to assess anxiety symptoms
* Pittsburgh Sleep Quality Index (PSQI) – to assess sleep quality
Assessments will be conducted at:
* Baseline (before intervention)
* Post-intervention (12 weeks)
* Follow-up (24 weeks)
Physiological Assessment
Serum cortisol levels will be measured in a subset of participants to evaluate biological stress response.
Data Analysis
Data will be entered into Microsoft Excel and analyzed using statistical software (SPSS). Descriptive statistics and appropriate statistical tests will be used to compare baseline and post-intervention outcomes. A p-value of less than 0.05 will be considered statistically significant.
Ethical Considerations
* Ethical approval will be obtained from the Institutional Ethics Committee before initiation of the study.
* Written informed consent will be obtained from all participants. For participants below 18 years, parental consent will also be obtained.
* Participation will be entirely voluntary, and participants may withdraw from the study at any time without consequences.
* Confidentiality and privacy of all participants will be strictly maintained.
* The yoga intervention is non-invasive and poses minimal risk to participants.
Expected Outcome
The study is expected to demonstrate that regular practice of the Common Yoga Protocol can significantly reduce stress and anxiety levels while improving sleep quality among adolescents. The findings may support the integration of structured yoga-based wellness programs in educational institutions to promote adolescent mental health.
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