| CTRI Number |
CTRI/2025/06/089156 [Registered on: 19/06/2025] Trial Registered Prospectively |
| Last Modified On: |
17/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Yoga Intervention ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Yoga protocol for Improving Phubbing, Impulsiveness, Mindfulness, and Lifestyle in School Students |
|
Scientific Title of Study
|
Integral Yoga Intervention for Managing Phubbing, Mindfulness, Impulsiveness, and Health Behaviours in Secondary School Students: A Randomized Control 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 |
Dr Rudra Bhandari |
| Designation |
Associate Professor |
| Affiliation |
University of Patanjali |
| Address |
University of Patanjali, Haridwar-249405, UK, India
Department of yoga, room no. 1, ground floor, University of Patanjali,Haridwar-249405, Uttarakhand
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9634510540 |
| Fax |
|
| Email |
yogidrrudra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rudra Bhandari |
| Designation |
Associate Professor |
| Affiliation |
University of Patanjali |
| Address |
Department of Yoga Science, Cabin No 1, Oriental Studies Block
Department of Yoga Science, Cabin No 1, Oriental Studies Block
Hardwar
UTTARANCHAL
249405
India |
| Phone |
09634510540 |
| Fax |
|
| Email |
yogidrrudra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yancy |
| Designation |
Research Scholar |
| Affiliation |
University of Patanjali |
| Address |
University of Patanjali, Haridwar-249405, UK, India
Department of Yoga Science, Ground Floor, University of Patanjali, Haridwar, Uttarakhand -249405
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9205225208 |
| Fax |
|
| Email |
sharmayancy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of yoga science, University of Patanjali, Haridwar, Uttarakhand -249405, India |
|
|
Primary Sponsor
|
| Name |
University of Patanjali |
| Address |
Delhi-Haridwar Highway, Patanjali Yogpeeth-I, Haridwar-249405, Uttarakhand |
| Type of Sponsor |
Other [Private University ] |
|
|
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 Rudra Bhandari |
Raghubir Singh Modern School |
Hall number 1, first floor, L 2, Mohan Garden, Uttam Nagar, New Delhi-110059
West
DELHI |
9205225208
YOGIDRRUDRA@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of University of Patanjali |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
1.Participants must be between 12 and 18 years old and attend secondary school, enrolled in a secondary school, and willing to attend the sessions. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Integral yoga intervention |
Participants will receive a 45-minute Integral Yoga session, conducted once daily, five days a week, for 3 months (12 weeks). The protocol includes asana, pranayama, mudra, bandha, meditation, and mantra |
| Comparator Agent |
Pratyahara (Sensory withdrawal) |
3 months, 45 min-5 days/week (12 weeks) Yoga Nidra |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Participants must be between 12 to 18 years old and attend secondary school and willing to engage in the integral yoga intervention and attend all scheduled sessions.
|
|
| ExclusionCriteria |
| Details |
Participants diagnosed with chronic/infectious illnesses, mental health, recent surgery, mental health disorders (e.g., depression, anxiety), or physical health conditions that could impede participation in yoga (e.g., severe asthma, epilepsy) will be excluded.
2.Participants who have practised yoga regularly (more than once a week) for at least six months will be excluded to avoid confounding effects.
3.Participants who report substance use (e.g., drugs, alcohol) that may affect their ability to engage in the study will be excluded.
4.Participants who cannot commit to attending the scheduled sessions and completing the follow-up assessments will be excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Phubbing of Secondary School Students |
At baseline (T0) and at 3 months (T1) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mindfulness, impulsiveness & lifestyle behaviors of Secondary School Students |
At baseline (T0) & at 3 months (T1) |
|
|
Target Sample Size
|
Total Sample Size="259"
Sample Size from India="259"
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)
|
01/07/2025 |
| 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="3"
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
|
In contemporary society, phubbing, characterized by diverting attention towards smartphones or digital devices during face-to-face interactions, has created a concerning trend among secondary school students. Coupled with impulsiveness, mindfulness, and health behaviour, these factors collectively contribute to a growing issue within this demographic. However, the educational setting’s attempts to cultivate learning environments conducive to holistic development, phubbing, impulsiveness, mindfulness, and healthy behaviour undermine these efforts significantly. The detrimental effects of phubbing, impulsiveness, mindfulness, and health behaviour on secondary school student’s academic performance, social interactions, emotional well-being, and overall mental health are increasingly evident. Furthermore, habitual engagement in these behaviours compromises cognitive abilities, emotional resilience, and social skills as a profound concern. Thus, a comprehensive understanding of the interplay between phubbing, impulsiveness, mindfulness, and health behaviour and their impact on secondary school students is critical to developing effective intervention strategies and fostering a healthier and more productive educational environment.
Yoga is increasingly popular due to its numerous physical and mental health benefits. In India, where yoga therapy is regulated by the Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homeopathy (AYUSH), Yoga is recognized for its holistic approach to health (Khemka et al., 2011). This study explores the integral yoga intervention for managing phubbing, impulsiveness, mindfulness, and healthy behaviour among secondary school students, examining how these factors intersect and manifest within the educational context of integral yoga intervention. Integral yoga, with its comprehensive approach to physical, mental, and spiritual well-being, can offer significant benefits for managing contemporary issues such as phubbing, impulsiveness, and health behaviours among secondary school students. |