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CTRI Number  CTRI/2024/07/070879 [Registered on: 19/07/2024] Trial Registered Prospectively
Last Modified On: 08/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effects of Yoga Nidra on brain activity and stress levels in young people with excessive social media use. 
Scientific Title of Study   Effects of Yoga Nidra on prefrontal cortical activity and perceived stress levels in young individuals with problematic social media usage. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sakshi Sharma 
Designation  M.Sc. Student 
Affiliation  All India Institute of Medical Sciences, Nagpur 
Address  Department of Physiology, 1st floor, College Building ,AIIMS Nagpur

Nagpur
MAHARASHTRA
441108
India 
Phone  8130187501  
Fax    
Email  Sakshi.sharmak455@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jyotsna Gumashta 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, Nagpur 
Address  1st Floor, Department of Physiology, AIIMS Nagpur

Nagpur
MAHARASHTRA
441108
India 
Phone  9425005683  
Fax    
Email  jyotsnagumashta@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Jyotsna Gumashta 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, Nagpur 
Address  1st Floor, Department of Physiology, AIIMS Nagpur

Nagpur
MAHARASHTRA
441108
India 
Phone  9425005683  
Fax    
Email  jyotsnagumashta@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Nagpur, 441108, India 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, Nagpur 
Address  plot No 2 sectoe 20, Mihan , Maharashtra, 441108 
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 
Dr jyotsna gumashta  All India Institute of Medical Sciences  Department of Physiology, Room no.118,Neurophysiology Lab.
Nagpur
MAHARASHTRA 		 9425005683

jyotsnagumashta@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMs nagpur Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Volunteers with Problematic Social media usage (currently it is not classified as a disease under ICD) 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Supine Relaxation Technique  The supine relaxation technique is a method aimed at promoting physical and mental relaxation involving finding a quiet and peaceful environment to lie down, allowing the body to rest in a supine position. It starts when individuals may focus on deep, rhythmic breathing to help calm the nervous system and release tension. The goal of supine relaxation is to achieve a state of deep calmness, both physically and mentally, fostering a sense of improvement and well-being. This practice can be incorporated into various relaxation routines, meditation sessions, or as a way to unwind before sleep. Duration of comparator arm: 10 minutes for 9 days every day.  
Intervention  Yoga Nidra  : Intervention will be started by giving the brief introduction of yoga nidra, emphasising its purpose in inducing a state of deep relaxation. Each yoga nidra session will last for about 20-25 minutes. Yoga nidra sessions will be conducted in batches of 5-10 participants. Participants will be instructed to lie down in a comfortable position, preferably in supine position and instruct participants not to sleep during the intervention. Participants will be instructed to take a resolve(sankalpa) that resonates with their deepest aspirations. Instructors will instruct participants to direct attention to different parts of the body. The facilitator will guide participants through the relaxation process by instructing participants to bring attention to their natural breath, without altering its rhythm. After that participants will be guided to visualise serene landscapes. Instructor will instruct the participants to recite the chosen sankalpa three times. Time Duration of intervention arm: 26 minutes for 9 days everyday 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1.Age group from 18 Years - 25 years of both genders will be included in this study.
2.Normal or corrected to normal vision (6/6 according to Snellen chart), normal colour vision assessed by Ishihara chart.
3.Individuals scoring more than 19 in the Bergen social media addiction scale. 
 
ExclusionCriteria 
Details  Participants having cognitive impairment secondary to conditions like history of stroke, brain injury, exposure to toxins or neuroleptics, history of neurological disease, dementia, Alzheimer’s disease or any neurological illness with significant cognitive impairment).
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in Prefrontal cortical activity and reduction in stress.  9 days 
 
Secondary Outcome  
Outcome  TimePoints 
To study the correlation between prefrontal cortical activity & perceived stress level in individuals with problematic social media users at baseline & after intervention.
 		 on day 1 & on day 9 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
Final Enrollment numbers achieved (Total)= "64"
Final Enrollment numbers achieved (India)="64" 
Phase of Trial   N/A 
Date of First Enrollment (India)   29/07/2024 
Date of Study Completion (India) 14/02/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 14/02/2025 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  		 INTRODUCTION: Problematic social media use( PSMU) refers to excessive engagement with social media, leading to negative mental health effects, particularly among young adults. This behavioral addiction is linked to increase stress, anxiety, depression and lower self esteem. stress is a state of mental and emotional strain and triggers flight and fight response. Stress can be caused by variety of factors including work pressure, personal relationship, financial issues, health concerns and environmental factors. In Problematic social media use, it is often a coping strategy for affected children and adolescents.

Functional Near infra red spectroscopy (fNIRS) is a non invasive  neuroimaging Technique that measures changes in haemoglobin concentrations in the  brain as an indirect measure of brain activity. It utilises near infrared light to penetrate the scalp and skull, allowing the measurement of oxygenated and deoxygenated haemoglobin levels in the cortical regions of brain. fNIRS  works by emitting near infra red light(typically of wavelength of 650 to 950nm) into the tissue, while detectors absorbed the amount of light absorbed and scattered by the brain tissue. Optodes are the light emitting diodes that have specific scalp position assigned to them and data collected from this optodes helps the researchers to  reconstruct and analyse brain activity in different brain regions .It is a non invasive technique that don’t have harmful radiations exposure and can helps in recording brain activity in PSMU.

  1. OBJECTIVES: To study the effects of Yoga Nidra on Pre- frontal cortical activity  in individuals with Problematic social media use.
  2. To study the effects of Yoga Nidra on perceived stress levels in individuals with a problematic social media use.
RESEARCH HYPOTHESIS: Yoga Nidra will lead to significant change in resultant prefrontal cortical activity and decremental in perceived stress levels in Problematic social media users.

METHADOLOGIES:
PRE - RECRUITMENT ASSESSMENT ( 1st  Day): BERGEN SOCIAL MEDIA ADDICTION SCALE ( 6 items in the scale score range from 1 to 5) i.e, participants scoring more than and equal to 19 out of 30 will be recruited in the study). 
BASELINE ASSESSMENT:
  1. Demographic Details
  2. Baseline Prefrontal cortical activity 
  3. baseline perceived stress levels by PSS( There are 10 items in the scale )(  score range from 0-40 where as 0-13 for low stress , 14-26 for moderate stress and 26-30 for high stress.
From 2nd to 10th Day( 9 days Intervention)
INTERVENTION: Yoga Nidra
SHAM GROUP: Supine Relaxation Technique
Participants were randomly assigned to interventional group and sham group.

11th Day: Post Measurements
  1. Pre-frontal Cortical Activity
  2. Perceived Stress Levels
RESULTS: Yoga Nidra Interventions led to significant decremental in Perceived Stress levels in both groups but no significant difference in PSS Score in both groups and there is no significant change in pre frontal cortical activity except there is pre -post significant difference in Deoxy-Hb Stroop task parameter , in case of N-3back task there is significant change in oxy parameter and total Hb parameter from pre to post intervention and there is significant change in total Hb levels between the groups in young individuals with Problematic social media usage 

 
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