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CTRI Number  CTRI/2024/07/071394 [Registered on: 26/07/2024] Trial Registered Prospectively
Last Modified On: 25/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   How Mindfulness and Dual-Tasking Can Help Social Media Users Think Better and Feel Less Stressed 
Scientific Title of Study   Combined Effect Of Dual-Task Training And Mindfulness Exercises On Cognition And Stress In Social Media Addicts 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mansi Deole 
Designation  Post Graduate Student 
Affiliation  KAHER Institute Of Physiotherapy 
Address  KLE Institute Of Physiotherapy JNMC Campus Nehru Nagar Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  8469039593  
Fax    
Email  mansi.deole11@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Raghavendrasingh Dharwadkar 
Designation  Assistant Professor 
Affiliation  KAHER Institute Of Physiotherapy 
Address  KLE Institute Of Physiotherapy JNMC Campus Nehru Nagar Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9886288225  
Fax    
Email  raghavendrasingh@klekipt.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Raghavendrasingh Dharwadkar 
Designation  Assistant Professor 
Affiliation  KAHER Institute Of Physiotherapy 
Address  KLE Institute Of Physiotherapy JNMC Campus Nehru Nagar Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9886288225  
Fax    
Email  raghavendrasingh@klekipt.edu.in  
 
Source of Monetary or Material Support  
KLE Academy Of Higher Education And Research, JNMC Campus, Nehru Nagar, Belagavi, Karnataka-590010, India 
 
Primary Sponsor  
Name  KLE Academy Of Higher Education And Research 
Address  JNMC Campus, Nehru Nagar, Belagavi, Karnataka-590010, India 
Type of Sponsor  Private medical college 
 
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 Mansi Deole  KLEs Dr. Prabhakar Kore Hospital and Medical Research Center  Department no. 39, Physiotherapy OPD, Nehru Nagar Belagavi, Karnataka-590010
Belgaum
KARNATAKA 
8469039593

mansi.deole11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KLE Academy of Higher Education  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Social Media Addicts 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dual Task Training Exercises And Mindfulness Exercises  Dual-Task Training will be given for 5 days per week for 30 minutes for 2 weeks and Mindfulness Exercises will be given for 5 days per week for 90 minutes for 2 weeks 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Subjects willing to participate in the study
Male and female participants in the age group of 18-25 years
Subjects with a score between 107-205 (moderate to high addiction) on the Social Media Addiction Scale
Subjects with moderate to high levels of stress (score of 14-40) as per the Perceived Stress Scale 
 
ExclusionCriteria 
Details  Participants diagnosed with any neurological, musculoskeletal conditions that restrict participation in dual-task training and mindfulness exercises

Contraindications for dual-task training and mindfulness exercises 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Cognition scores
Stress levels 
the cognition scores and stress levels will be assessed during the initial visit i.e. at the baseline(t0) and the cognition scores and stress levels will be reassessed after the intervention is completed after 4 weeks (t1)
so t0 will be at baseline and t1 will be at the 4th week 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/08/2024 
Date of Study Completion (India) 01/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
Introduction and need of the study-
Social media refers to third-party internet-based platforms that prioritize user-generated content, community-based contributions, and social interactions within their user base.
As seen by the rising number of everyday users, social media consumers have made online social communication an indispensable part of their daily lives.
There is a growing body of evidence suggesting social media use can negatively affect one’s psychological well-being.
Excessive use of social media due to higher Fear of Missing Out (FoMO) can cause cognitive failures and reduce focus on daily activities due to distraction.
Although research has shown that mindfulness exercises are effective in reducing stress and that dual-task training has an impact on cognition in different conditions, there is a dearth of literature regarding the effects of combining these two interventions for stress and cognition, particularly in the context of people who are addicted to social media.
The purpose of this study is to find out the potential effects of dual-task training and mindfulness exercises on the cognitive abilities and stress levels of social media addicts in light of the growing prevalence of social media addiction and the cognitive deficits associated with it in young people.

AIM
To evaluate the combined effect of dual-task training and mindfulness exercises on cognition and stress in social media addicts
OBJECTIVES
To evaluate the combined effect of dual-task training and mindfulness exercises on:
Cognition using Lumosity (Lumos Labs, Inc.)
Stress using Perceived Stress Scale

HYPOTHESIS
Null hypothesis: There will be no effect of combined dual-task training and mindfulness exercises on cognition and stress in social media addicts
Alternative hypothesis: There will be an effect of combined dual-task training and mindfulness exercises on cognition and stress in social media addicts

PROCEDURE
The participants will be screened for moderate to high social media addiction (scores between 107 and 205) using the Social Media Addiction Scale and moderate to high perceived stress (scoring 14-40 on the PSS).
From those screened, participants will be recruited as per the inclusion and exclusion criteria.
The purpose and procedure of the study will be explained to the participants and written informed consent will be obtained for the same.
The baseline cognition levels will be assessed for different domains.
The initial perceived stress levels will be documented.
Dual-task training will be given: 5 days/week X 30 minutes X 2 weeks
Mindfulness exercises: 5 days/week X 90 minutes X 2 weeks
All the participants will receive the above interventions.
Post treatment the scores on different domains for cognitive abilities and perceived stress levels will be documented on the last day of intervention.
The collected data will be tabulated, interpreted and further analysis will be done.

Intervention-
Dual-task training
Training frequency- 5 days per week
Training duration- 30 minutes
Number of weeks- 2 weeks
Activity duration- 3 minutes each
Dual-task exercises
Mathematical subtraction while walking
Reciting a sentence backwards while walking
Holding of glass of water without spilling during backward walking
Balancing on BOSU ball while reciting a category of words
Treadmill walking while calculating mathematical equations
Specific set of motor tasks for a specific sound stimulus
Tandem walking while listening to a story and recollecting it after interruption
A song will be played and interrupted and the participant is encouraged to continue without getting distracted while balancing
Cycling while solving puzzles
Obstacle walking while answering general knowledge issues

Mindfulness exercises
Count 10 breaths and brief breathing meditation
Raisin meditation
Sitting meditation
Guided sitting meditation
Body scan meditation
Loving-kindness meditation
Mindful walking meditation
Silent meditation
 
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