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CTRI Number  CTRI/2025/11/097124 [Registered on: 10/11/2025] Trial Registered Prospectively
Last Modified On: 26/06/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of a short session of guided mindfulness meditation on mental focus and memory in young adults using mobile phones for extended hours. 
Scientific Title of Study   Immediate effect of guided mindful meditation on attention and working memory in young adults with extended duration mobile phones use: A Randomized Comparative Study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MGMCRI/Res/01/2024/8/IHEC/68   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nisha Afreen 
Designation  Postgraduate Department of Physiology 
Affiliation  Mahatma Gandhi Medical College and Research Institute 
Address  Department of Physiology Mahatma Gandhi Medical College and Research Institute Pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  9585256560  
Fax    
Email  nisha.fayaz8na@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nikhilesh Singh 
Designation  Professor Department of Physiolgy 
Affiliation  Mahatma Gandhi Medical College and Research Institute 
Address  Department of Physiology Mahatma Gandhi Medical College and Research Institute Pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  9787314046  
Fax    
Email  nikhileshsingh@mgmcri.ac.in   
 
Details of Contact Person
Public Query  
Name  Dr Nikhilesh Singh 
Designation  Professor Department of Physiolgy 
Affiliation  Mahatma Gandhi Medical College and Research Institute 
Address  Department of Physiology Mahatma Gandhi Medical College and Research Institute Pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  9787314046  
Fax    
Email  nikhileshsingh@mgmcri.ac.in   
 
Source of Monetary or Material Support  
Department of Physiology Mahatma Gandhi Medical College and Research Institute Pillaiyarkuppam, Pondicherry- 607402  
 
Primary Sponsor  
Name  Dr Nisha Afreen 
Address  Department of Physiology Mahatma Gandhi Medical College and Research Institute, Pillaiyarkuppam, Pondicherry- 607402 
Type of Sponsor  Other [Self] 
 
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 
Dr Nisha Afreen  Mahatma Gandhi Medical College and Research Institute  Ground Floor Room no 5 in Research Lab Department of Physiology Mahatma Gandhi Medical College Block
Pondicherry
PONDICHERRY 		 9585256560

nisha.fayaz8na@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  No diseased individual will be included 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Controlgroup Relaxing Music  Relaxing background music with without meditation instruction using the same smiling mind app. Duration 10 minutes 
Intervention  Mindful mediation   Mindful meditation with background music using smiling mind app. Duration: 10 minutes 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1 Age 19 to 25 years.
2 Screen time : Regular mobile phone users(more than 2hours per day)
3 Be proficient in English, to understand instructions and perform cognitive tasks.
4 Be available to complete the full study protocol without scheduling conflicts.
5 Have no self-reported cognitive or neurological impairments 
 
ExclusionCriteria 
Details  1 Are regular practitioners of mindfulness or meditation (e.g., more than
once per week over the past 6 months).
2 Have a history of neurological, psychiatric, or cognitive disorders.
3 Are currently on medications/substances affecting cognitive functions.
4 Have diagnosed sleep disorders not caused by mobile phone use (e.g., clinical insomnia, sleep apnea).
5 Have uncorrected visual or auditory impairments that interfere with app use or task performance.
6 Those who are not using smart phones. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Stroop task - Accuracy,
Interference and response time
mSpan test - Accuracy, maximum
chain length response time
and response time 		 At single point of time 
 
Secondary Outcome  
Outcome  TimePoints 
To explore whether the effect of brief meditation is more prominent in either attention or working memory.   At single point of time 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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)   01/12/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  		 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-identiļ¬cation.

  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 who provide a methodologically sound proposal.

  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 [nisha.fayaz8na@gmail.com].

  6. For how long will this data be available start date provided 08-01-2027 and end date provided 01-01-0001?
    Response - Immediately following publication. No end date.

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

This study is a randomized single blinded parallel group design conducted in the Department of Physiology, MGMC and RI. Participants were recruited according to predefined inclusion and exclusion criteria, and written informed consent was obtained. Mobile phone screen time was recorded using Apple Screen Time for iOS users or Digital Wellbeing for Android users to ensure eligibility of more than two hours of mobile use per day.

On Day 1 (baseline assessment), participants underwent a ten minute session of their preferred mobile activity such as social media, gaming, or video streaming, followed by cognitive testing using the Color Based Stroop Task and mSpan Test administered through the PEBL software to assess attention, executive function, and working memory.

On Day 2 (intervention phase), participants were randomly assigned to either the Mindfulness Intervention Group, which practiced a ten minute guided Body Scan Meditation using the Smiling Mind application, or the Relaxation Control Group (placebo), which rested quietly with relaxing music using the same application.

After the mindfulness session, participants in the intervention group were asked to rate their experience using the Body Scan Meditation Rating Scale. If the score was equal to or greater than seven, they proceeded to perform the post intervention cognitive tasks. If the score was less than seven, participants were asked to return the next day to repeat the meditation session before undergoing cognitive testing.

Post intervention performance data from both groups were compared with their respective baseline scores to evaluate the immediate effects of mindfulness meditation on cognitive function in individuals with extended mobile phone use.

Current status (jun2 2026): The trial is ongoing and recruitment is continuing as per the approval protocol. A total of 40 participants have been enrolled out of the planned sample size of 56 participants. No major protocol deviations or safety concerns have been reported.

 
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