| CTRI Number |
CTRI/2025/12/099069 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
12/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Yoga as an Intervention for Smartphone Dependence among University Students |
|
Scientific Title of Study
|
Effect of eight week Yoga intervention on Executive function and Psychological well- being in smartphone dependent university students: 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 |
Prof Raghavendra Bhat |
| Designation |
Professor |
| Affiliation |
Central university of Rajasthan |
| Address |
Department of Yoga, Central University of Rajasthan NH-8, Bandersindari, Kishangarh Ajmer RAJASTHAN 305817 India |
| Phone |
8147226351 |
| Fax |
|
| Email |
raghavendra.bhat@curaj.ac.in |
|
Details of Contact Person Scientific Query
|
| Name |
Gautam Mishra |
| Designation |
Research Scholar |
| Affiliation |
Central university of Rajasthan |
| Address |
Department of Yoga, Central University of Rajasthan NH-8, Bandersindari, Kishangarh Ajmer RAJASTHAN 305817 India |
| Phone |
7086216560 |
| Fax |
|
| Email |
2023phdyg003@curaj.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Gautam Mishra |
| Designation |
Research Scholar |
| Affiliation |
Central university of Rajasthan |
| Address |
Department of Yoga, Central University of Rajasthan NH-8, Bandersindari, Kishangarh Ajmer RAJASTHAN 305817 India |
| Phone |
7086216560 |
| Fax |
|
| Email |
2023phdyg003@curaj.ac.in |
|
|
Source of Monetary or Material Support
|
| Department of Yoga, Central University of Rajasthan, NH-8, Bandersindari, Kishangarh, Ajmer District Rajasthan-305817, India |
|
|
Primary Sponsor
|
| Name |
Gautam Mishra |
| Address |
Department of Yoga, Central University of Rajasthan, NH-8, Bandersindari, Kishangarh, Ajmer District Rajasthan-305817, India |
| Type of Sponsor |
Other [Central 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 |
| Gautam Mishra |
Central University of Rajasthan |
Department of Yoga, Central University of Rajasthan, NH-8, Bandersindari, Kishangarh Ajmer RAJASTHAN |
7086216560
misragg1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Institutional Ethics Committee Central University of Rajasthan, Ajmer |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Smartphone Addiction |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Waitlist Control |
No intervention during study period |
| Intervention |
Yoga module for Smartphone Addiction |
Previously developed and validated yoga module for smartphone addiction, supervised sessions of 60 minutes, 3 times per week for 2 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
29.00 Year(s) |
| Gender |
Both |
| Details |
Screening, Potential participants will be screened with SAS-SV.
|
|
| ExclusionCriteria |
| Details |
Participants with serious medical illnesses affecting brain function, a history of head injury, substance or alcohol dependence, long-term medication use, pregnancy, or prior experience in yoga will be excluded from the study. |
|
|
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 |
Executive function test and Psychological measures
|
At Baseline, 8 weeks and 12 weeks |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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)
|
12/01/2026 |
| 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="6" 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
|
The
rising prevalence of smartphone addiction among university students has become
a growing concern due to its negative impact on executive functions and
psychological well-being. Persistent and compulsive smartphone use has been
linked to increased cognitive load, reduced working memory, cognitive
flexibility, and inhibition, along with elevated levels of stress, anxiety,
poor mindfulness, and disrupted sleep quality. This study aims to evaluate the
effectiveness of yoga, a holistic mind-body practice integrating postures,
breathing, and meditation, in enhancing executive function and psychological
well-being among university students with high smartphone dependency. It will
assess improvements across cognitive and psychological domains, as well as the
sustainability of these effects after the intervention, while also exploring
yoga’s influence on screen time and smartphone addiction. The present
randomized controlled trial aims to evaluate the effects of a structured yoga
intervention on executive functioning and psychological well-being among
smartphone-dependent university students. Participants will be screened for
eligibility using the Smartphone Addiction Scale Short Version. Eligible
students will then be randomized into two groups: an intervention group
receiving the Smartphone Yoga Module practice for two months (three sessions
per week, sixty minutes per session) and a control group with no intervention.
Both groups will complete pre- and post-assessments that include executive
function tasks, as well as psychological measures assessing stress,
mindfulness, and sleep quality. A follow-up assessment will be conducted one
month after the intervention period to evaluate the sustainability of
improvements. This study seeks to validate yoga as a practical, accessible, and
non-pharmacological approach to enhancing executive function and psychological
resilience among smartphone-dependent university students. |