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CTRI Number  CTRI/2025/03/083584 [Registered on: 27/03/2025] Trial Registered Prospectively
Last Modified On: 26/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Other 
Public Title of Study   Exploring the Mind-Body Connection: How Yoga Affects Smartphone Use and Well-being in Undergraduate Healthcare Students 
Scientific Title of Study   Biopsychosocial effects of yoga on smart phone usage among undergraduate health care students 
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. Ananda Balayogi Bhavanani 
Designation  Professor & Director 
Affiliation  Sri Balaji Vidyapeeth deemed-to be University 
Address  Institute of Salutogenesis and Complementary Medicine, Sri Balaji Vidyapeeth, pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  9842311433  
Fax    
Email  abbhavanani@mgmcri.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Sumitra Sudharkodhy S 
Designation  Ph.D. Scholar 
Affiliation  Sri Balaji Vidyapeeth deemed-to be University 
Address  Institute of Salutogenesis, &Complementary Medicine, Sri Balaji Vidyapeeth deemed-to be University, Pondicherry
Department of Physiology,Karpaga vinayaga institute of medical sciences and research Center, GST Road, Chinnakolambakkam, palayanoor post , chengalpet
Pondicherry
PONDICHERRY
607402
India 
Phone  8675686668  
Fax    
Email  sumitradoctor@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sumitra Sudharkodhy S  
Designation  Ph.D. Scholar  
Affiliation  Sri Balaji Vidyapeeth deemed-to be University 
Address  Institute of Salutogenesis, &Complementary Medicine, Sri Balaji Vidyapeeth deemed-to be University, Pondicherry, India

Pondicherry
PONDICHERRY
607402
India 
Phone  8675686668  
Fax    
Email  sumitradoctor@gmail.com  
 
Source of Monetary or Material Support  
Karpaga Vinayaga Medical college,GST ROAD,CHINNAKOLAMBAKAM, CHENGALPET, TAMILNADU 603308. INDIA 
 
Primary Sponsor  
Name  Karpaga Vinayaga Medical college 
Address  GST road chinnakolambakam palayanoor post chengalpet 603308 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrSumitra  karpaga vinayaga medical college and hospital, Tamilnadu, India  Department of Physiology, first floor, college building
Kancheepuram
TAMIL NADU 		 8675686668

sumitradoctor@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Karpaga Vinayaga Institute of Medical Sciences & Research Centre, India.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  normal 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  no intervention  not tom practice yoga or sports for three months 
Intervention  yoga   yoga asanas and meditation for 3 months five days a wk for 45 min/day 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  23.00 Year(s)
Gender  Both 
Details  Healthy undergraduate health care students including MBBS, BDS and AHS .
Age group between 18-23 years.
Subjects with normal visual acuity or corrected by the glasses.
 
 
ExclusionCriteria 
Details  Known history of major illness which interferes with visual evoked potentials like diabetic retinopathy, optic atrophy, glaucoma, etc.
Known history of major illness which interferes with Heart rate variability like coronary heart disease, heart failure, congenital heart disease, a history of arrhythmia, neurological disease and endocrine disorder.
Known history of major illness which interferes with cognition like Neurocognitive disorders etc.
Any physical and mental illness that affect yoga practice.
Those who were practicing yoga for minimum of 6 months duration.
Those using other gadgets like computer, television , tablet for more than 3hours
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Giving Perspective of yoga as a variable solution to control the symptoms that occurs due to smartphone overuse
 		 2 YEARS 
 
Secondary Outcome  
Outcome  TimePoints 
mobile phone overuse will reduce  2 YEARS 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   05/05/2025 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sumitradoctor@gmail.com].

  6. For how long will this data be available start date provided 14-03-2024 and end date provided 14-01-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Undergraduate heath care students in the courses like MBBS, BDS, AHS under the age group of 18-23 years will be included in the study from Karpaga Vinayaga Medical sciences and research institute. Based on their smart phone usage found by standardised questionnaire, they will be grouped into Group I and Group II . Group I are those using smart phone for less than 3 hrs/day and Group II are those using smart phone for more than 3 hrsday. For both the groups baseline parameters will be taken. and for Group II yoga intervention will be given for 3 months duration by trained yoga instructor. Then again all the parameters will be recorded and the values obtained will be analysed statistically.

 
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