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CTRI Number  CTRI/2023/05/053294 [Registered on: 31/05/2023] Trial Registered Prospectively
Last Modified On: 30/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Impact of smartphone use on mental health among Young adults. 
Scientific Title of Study   Impact of smartphone use on Cognition among Young adults. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Krati khandelwal 
Designation  M.P.T 
Affiliation  Dr. D.Y. Patil College of Physiotherapy, Pimpri, Pune 
Address  Dr. D.Y. Patil College of Physiotherapy, Dr D.Y Patil Vidyapeeth, Sant Tukaram Nagar, Pimpri, Pune

Pune
MAHARASHTRA
411018
India 
Phone  7030609060  
Fax    
Email  kratikhandelwal24@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Preeti Gazbare 
Designation  Professor 
Affiliation  Dr. D.Y. Patil College of Physiotherapy, Pimpri, Pune 
Address  Dr. D.Y. Patil College of Physiotherapy, Dr D.Y Patil Vidyapeeth, Sant Tukaram Nagar, Pimpri, Pune

Pune
MAHARASHTRA
411018
India 
Phone  9096116134  
Fax    
Email  Preeti.gazbare@dpu.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Preeti Gazbare 
Designation  Professor 
Affiliation  Dr. D.Y. Patil College of Physiotherapy, Pimpri, Pune 
Address  Dr. D.Y. Patil College of Physiotherapy, Dr D.Y Patil Vidyapeeth, Sant Tukaram Nagar, Pimpri, Pune

Pune
MAHARASHTRA
411018
India 
Phone  9096116134  
Fax    
Email  Preeti.gazbare@dpu.edu.in  
 
Source of Monetary or Material Support  
Dr. D.Y.Patil College of Physiotherapy,Pimpri , Pune 
 
Primary Sponsor  
Name  Krati Khandelwal 
Address  Dr. D.Y. Patil College of Physiotherapy, Dr D.Y Patil vidhyapeet,Sant Tukaram Nagar, Pimpri, Pune 
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 
Krati Khandelwal  Dr. D.Y. Patil College of Physiotherapy  Dr.D.Y.Patil College of Physiotherapy, Kinesiotherapy and Movement sciences Department 3rd floor,Dr D.Y Patil Vidyapeeth,Sant Tukaram nagar, Pimpri,Pune
Pune
MAHARASHTRA 
7030609060

kratikhandelwal24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Dr. D.Y. Patil College of Physiotherapy, Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  smartphone users 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1)Individuals who are voluntarily participating in the study
2)20-30 years old
3) Screen time ≥ 2 hours/day
 
 
ExclusionCriteria 
Details  1)Any neurological disorders like SCI,TBI,
2)Any diagnosed psychiatric disorders like depression, anxiety, ADHD 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)Smart phone addiction scale
2)Self-made questionnaire
3) Computerized neurocognitive test battery
4)DAAS-21 scale
 
ONCE (Baseline) 
 
Secondary Outcome  
Outcome  TimePoints 
1)Epworth sleep scale
2)General procrastination scale
 
ONCE (Baseline) 
 
Target Sample Size   Total Sample Size="511"
Sample Size from India="511" 
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)   12/06/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Smartphones has become a more integral part of everyday life, holding more capabilities of enhancing critical cognitive processes, if not entirely replacing them. With the ability to act as a telephone directory, appointment scheduler, tip calculator, navigator, and gaming device, smartphones appear capable of doing an unlimited number of cognitive activities and satisfying a significant number of our affective demands on our behalf.Cognitive failures are frequently characterized by attentional gaps and are thought to be common in daily living. These attentional deficits may be caused by endogenous processes like ruminations or daydreaming or exogenous factors like distracting stimuli. 

Smartphones have a tendency to immediately capture the attention of those engaged in an activity that is unrelated to the smartphone. A three-second distraction such as reaching for a cell phone is sufficient to divert attention away from a cognitive task, and it has been demonstrated that the mere possession of a smartphone has a detrimental effect on working memory capacity, fluid intelligence, and attentional processes.Excessive use of smartphones has been associated with several negative consequences for individuals, such as limitations in decision-making skills, problem-solving, attention, memory, executive controls, and reaction time.

Therefore, there is a need to find the impact of smartphone use on cognition in young adults, to understand how smartphones impact us to take the required precautions to avoid harmful outcomes.

 
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