| CTRI Number |
CTRI/2023/08/056354 [Registered on: 10/08/2023] Trial Registered Prospectively |
| Last Modified On: |
16/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effects of Action and Puzzle Mobile games on Health |
|
Scientific Title of Study
|
Comparison of Cognition, Personality and Psychological Health parameters between Action and Puzzle mobile-gamers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sushant Shekhar Katiyar |
| Designation |
Junior Resident (PG) |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Physiology,
Maulana Azad Medical College,
Bahadur shah zafar marg,
New Delhi - 110002
Central
DELHI
110002
India |
| Phone |
8004612381 |
| Fax |
|
| Email |
sushant.katiyar6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preeti Jain |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Physiology,
Maulana Azad Medical College,
Bahadur shah zafar marg,
New Delhi - 110002
Central
DELHI
110002
India |
| Phone |
9968604354 |
| Fax |
|
| Email |
drpreetijain@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preeti Jain |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Physiology,
Maulana Azad Medical College,
Bahadur shah zafar marg,
New Delhi - 110002
Central
DELHI
110002
India |
| Phone |
9968604354 |
| Fax |
|
| Email |
drpreetijain@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College, New Delhi |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College,
Bahadur shah zafar marg,
New Delhi - 110002 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Sushant Shekhar Katiyar |
Maulana azad medical college |
Department of Physiology,
Maulana azad medical college,
Bahadur shah zafar marg,
New Delhi - 110002
Central
DELHI |
8004612381
sushant.katiyar6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee , Maulana Azad medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mobile gaming ( activity on hand held electronic device) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who play either action or puzzle genre of mobile-games for at least past 6 months. |
|
| ExclusionCriteria |
| Details |
1. Subjects who play other genres of mobile-games like role-playing, racing, strategy, arcade and esports.
2. Subjects with history of any auditory or visual ailment, neurological disorder, psychological disorder, musculoskeletal disorder or sleep related disorder.
3.Subjects who are on any medication which is likely to affect cognition |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Psychological Health
2. Cognition
3. Personality traits |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gaming Addiction |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/08/2023 |
| Date of Study Completion (India) |
01/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
In the proposed study we aim to assess and compare the influence of playing action and puzzle genre of Mobile games on Cognition,Personality and psychological health parameters in young adults. The study will be conducted in the Maulana Azad medical college and associated LNJP hospital and GIPMER, New Delhi |