| CTRI Number |
CTRI/2025/08/092982 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Yoga Module] |
| Study Design |
Other |
|
Public Title of Study
|
Effect of yoga on Mobile Phone Addiction, Sleep and Attention |
|
Scientific Title of Study
|
Effect of Yoga Module on Quality of Sleep, Attention and Mobile Phone Addiction in School Students |
| Trial Acronym |
No |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arti Yadav |
| Designation |
Assistance Professor |
| Affiliation |
University of Patanjali |
| Address |
Department of Yoga science, Ground floor, University Building, Patanjali Yogpeeth Phase 1,
Bahadrabad, Hardwar UTTARANCHAL 249405 India Department of Yoga science, Ground floor, University Building, Patanjali Yogpeeth Phase 1,
Bahadrabad, Hardwar UTTARANCHAL 249405 India Hardwar UTTARANCHAL 249405 India |
| Phone |
9557710802 |
| Fax |
|
| Email |
arti@uop.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Arti Yadav |
| Designation |
Assistance Professor |
| Affiliation |
University of Patanjali |
| Address |
Department of Yoga science, Ground floor, University Building, Patanjali Yogpeeth Phase 1,
Bahadrabad, Hardwar UTTARANCHAL 249405 India Department of Yoga science, Ground floor, University Building, Patanjali Yogpeeth Phase 1,
Bahadrabad, Hardwar UTTARANCHAL 249405 India Hardwar UTTARANCHAL 249405 India |
| Phone |
9557710802 |
| Fax |
|
| Email |
arti@uop.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Arti Yadav |
| Designation |
Assistance Professor |
| Affiliation |
University of Patanjali |
| Address |
Department of Yoga science, Ground floor, University Building, Patanjali Yogpeeth Phase 1,
Bahadrabad, Hardwar UTTARANCHAL 249405 India Department of Yoga science, Ground floor, University Building, Patanjali Yogpeeth Phase 1,
Bahadrabad, Hardwar UTTARANCHAL 249405 India Hardwar UTTARANCHAL 249405 India |
| Phone |
9557710802 |
| Fax |
|
| Email |
arti@uop.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
University of Patanjali |
| Address |
Patanjali Yogpeeth Phase 1 Bahadrabad Haridwar 249405 |
| Type of Sponsor |
Research institution |
|
|
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 Arti Yadav |
University of Patanjali |
Department of Yoga science, Ground floor, University Building, Patanjali Yogpeeth Phase 1,
Bahadrabad, Hardwar UTTARANCHAL 249405 India Hardwar UTTARANCHAL |
09557710802
arti@uop.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
both are Male/Female |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Yoga Module |
Pranayama 15min, Asana 40min, Sukshma vyayama 5min
Bhastrika 3 Manduka asana 3 Flexion, extension, rotation of
Shoulder 3
Kapalabhati 2 Shashkasana 3 Flexion, extension of elbow &
Fingers 2
Baahya 1 Vakrasana 3
Ujjayi 1 Gomukhasana 3
Anulomvilom 2 Bhujangasana 3
Bhramari 2 Shalbhasna 3
Udgeeth 2 Markatasana 3
Pranav 2 Dvi Chakrika (cycling) 3
Pavan Mukta asana 3
Paadavritta asana 3
Shavaasana (relax) 10
Total 60 min |
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1.1 Healthy participants both genders.
1.2 Those students who will be willing to follow study conditions
1.3 The age range will be between 11 and 16 years.
1.4 Those participants will be using mobile phone for at least more than 4 hours per day (using mobile phone check list).
|
|
| ExclusionCriteria |
| Details |
7.2.1 Students with a diagnosed mental disorder
7.2.2 Students will take any medication or use any other wellness strategy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome Variables:
Mobile Phone Addiction
Measurement: The severity of mobile phone addiction will be assessed using validated scales such as the Mobile Phone Dependence.
|
8 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Quality of Sleep
Measurement: Sleep quality will be assessed using standardized tools such as the Pittsburgh
Sleep Quality Index (PSQI) questionnaires.
|
At baseline (T0)and at Two months (T1) |
| Measurement: Attention will be measured using tools trail making test (TMT). |
At baseline (T0)and at Two months (T1) |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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)
|
18/08/2025 |
| 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="1" Months="0" 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
|
This study approach to
address three interrelated challenges faced by school-going adolescents—poor
sleep quality, reduced attention span and excessive mobile phone use—through a
structured yoga module. While previous studies have individually explored the
effects of yoga on sleep (Talwadkar et al., 2014), attention (Chhaya et al.,
2012) or technology addiction (Taneja et al., 2019), very few have examined
these outcomes together in the context of a single holistic intervention among
a school-aged population. This research involves the implementation of a
comprehensive yoga module designed specifically for adolescents, incorporating
asanas, pranayama, meditation to target behavioral and cognitive regulation.
Additionally, the growing public health concern among adolescents, involving
mobile phone addiction, adds a contemporary relevance to the study. The aim of
this study is not only to provide empirical evidence for the multidimensional
benefits of yoga but also to inform school-based wellness programs and national
mental health policies for students. |