| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
smartphone users |
|
|
Intervention / Comparator Agent
|
|
|
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)Â 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. |