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CTRI Number  CTRI/2025/07/091284 [Registered on: 21/07/2025] Trial Registered Prospectively
Last Modified On: 27/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy
Other (Specify) [Physical excercise]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   How yoga and physical exercise will help to High school students to reduce excessive use of smart phone and improve their emotional intelligence.  
Scientific Title of Study   A Comparative study of efficacy of yoga therapy and physical exercises in smartphone addicted high school students on their emotional intelligence 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Manjusha Sudhir Pawar 
Designation  PhD scholar 
Affiliation  Dr.D Y Patil ayurved college and research centre. Pune 
Address  Sumant bungalow,Wakte corner, Nandanvan nagar, Savedi ,Ahmednagar
Sant Tukaram nagar, Pimpari, Pune
Pune
MAHARASHTRA
414003
India 
Phone  9423766834  
Fax    
Email  manjushapawarswasth@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Urmila J.Shirke 
Designation  Professor and Head 
Affiliation   
Address  Department of Swasthavritta, Dr D Y Patil College of Ayurved and Research Center, Sant Tukaram Nagar , Pimpri , Pune , Maharashtra , India

Pune
MAHARASHTRA
411018
India 
Phone  9850769938  
Fax    
Email  drujshirke@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Manjusha Sudhir Pawar 
Designation  PhD scholar 
Affiliation  Dr.D Y Patil ayurved college and research centre. Pune 
Address  Sumant bungalow,Wakte corner, Nandanvan nagar, Savedi ,Ahmednagar
Sant Tukaram nagar, Pimpari, Pune
Pune
MAHARASHTRA
414003
India 
Phone  9423766834  
Fax    
Email  manjushapawarswasth@gmail.com  
 
Source of Monetary or Material Support
Modification(s)  
Dnyansampada School, Tapovan Road, Savedi, Ahmednagar – 414003, Maharashtra, India 
 
Primary Sponsor  
Name  Manjusha Sudhir Pawar 
Address  Sumant Bungalow,Nandanvan Nagar, Savedi, Ahmednagar , 414003 ,Maharashtra , India 
Type of Sponsor  Other [Self Sponsered] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manjusha Sudhir Pawar  Dnyansampada School  Tapovan Road, Savedi, Ahmadnagar, Maharashtra – 414003
Ahmadnagar
MAHARASHTRA 		 9423766834

manjushapawarswasth@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr. D. Y. Patil College of Ayurved & Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Smartphone addicted 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Physical excercise  A structured physical training (PT) session of 35 minutes daily for 60 days conducted by a qualified PT instructor. Counseling will be provided one day before the start of the intervention and twice a month thereafter, focusing on awareness of smartphone misuse and its impact on physical, mental, and social health. Sessions include fast exercises such as spot jogging, bending, body rotation, and coordinated hand and leg movements. Educational lectures will be provided on topics such as positive attitude, self-image, motivation, communication, goal setting, and leadership. Menstruating girls will be advised to avoid fast movements like spot jogging and instead perform slower, simple PT exercises. 
Intervention  Yoga Therapy  A structured yoga therapy session of 35 minutes per day for 60 consecutive days. Each session includes: - 5 minutes of warm-up (Sharir Sanchalan) - 20 minutes of asanas (yogic postures) - 5 minutes of pranayam (breathing techniques) - 5 minutes of dharana and dhyan (concentration and meditation) 
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  1. Smartphone addicted highschool students


2. Students ready to give written assent and able to attend yoga therapy or physical exercises training independently
 
 
ExclusionCriteria 
Details  1. Students with major physical illness 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in Emotional Intelligence score among smartphone-addicted high school students, assessed using a standardized Emotional Intelligence Scale.  Baseline (Day 0) and Post-intervention (Day 60)

 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in duration of smartphone usage, changes in behavior.  Baseline (Day 0) and Post-intervention (Day 60)
 
 
Target Sample Size
Modification(s)  		 Total Sample Size="136"
Sample Size from India="136" 
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   Phase 2 
Date of First Enrollment (India)   26/12/2025 
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="2"
Days="10" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 This is a Phase II, prospective, interventional clinical trial aimed at evaluating the comparative effectiveness of yoga therapy and physical exercises in improving emotional intelligence among high school students diagnosed with smartphone addiction. The study will enroll 68 participants who will be randomly allocated to two groups: one receiving structured yoga therapy and the other undergoing physical exercise sessions. The trial duration includes pre- and post-intervention assessments using standardized tools. The primary outcome is the improvement in emotional intelligence, while secondary outcomes include reduced screen time, behavioral improvements. The trial is being conducted exclusively in India and is currently in the ’Not Yet Recruiting’ phase. 
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