| CTRI Number |
CTRI/2023/08/056434 [Registered on: 11/08/2023] Trial Registered Prospectively |
| Last Modified On: |
10/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Multiplayer Online Battle Arena Games(MOBAs) on the mental health of adolescent population after the pandemic |
|
Scientific Title of Study
|
Multiplayer Online Battle Arena Games (MOBAs) and Mental Health of Adolescents in the Post Pandemic World: A Cross-Sectional Survey |
| 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 Sarnava Hazra |
| Designation |
Junior Resident |
| Affiliation |
Central Institute Of Psychiatry |
| Address |
Central Institute of Psychiatry, Kanke, Ranchi, Jharkhand.
Ranchi
JHARKHAND
834006
India |
| Phone |
9474026235 |
| Fax |
|
| Email |
sarnava.hazra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varun S Mehta |
| Designation |
Associate Professor of Psychiatry |
| Affiliation |
Central Institute of Psychiatry |
| Address |
Central Institute of Psychiatry(CIP), Kanke, Ranchi, Jharkhand
Ranchi
JHARKHAND
834006
India |
| Phone |
9204858189 |
| Fax |
|
| Email |
vs_mehta@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varun S Mehta |
| Designation |
Associate Professor of Psychiatry |
| Affiliation |
Central Institute of Psychiatry |
| Address |
Central Institute of Psychiatry(CIP), Kanke, Ranchi, Jharkhand
Ranchi
JHARKHAND
834006
India |
| Phone |
9204858189 |
| Fax |
|
| Email |
vs_mehta@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Central Institute of Psychiatry, Kanke, Ranchi-834006, India |
|
|
Primary Sponsor
|
| Name |
Central Institute of Psychiatry |
| Address |
Central Institute of Psychiatry |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Varun S Mehta |
Central Institute of Psychiatry |
Kanke, Ranchi, Jharkhand-834006
Ranchi
JHARKHAND |
9204858189
vs_mehta@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, CIP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adolescent populations playing Multiplayer Online Battle Arena(MOBA) games, Non-Multiplayer Online Battle Arena(MOBA) games and not playing any games |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA FOR GAMERS (MOBA & NON MOBA)
1. Adolescents of either gender aged 11 years to less than 18 years.
2. Adolescents who can read and understand English.
3. Adolescents having access to any electronic devices like mobile phones, laptops, personal computers, or gaming consoles.
4. Adolescents who are spending at least 30 minutes of his time every day playing games.
5. Parent of the adolescent giving a written informed consent for participation in the study and the adolescent providing an assent for participation.
INCLUSION CRITERIA FOR NON GAMERS (MOBA & NON MOBA)
1. Adolescents of either gender aged 11 years to less than 18 years.
2. Adolescents who can read and understand English.
3. Adolescents having access to any electronic devices like mobile phones, laptops, personal computers, or gaming consoles.
4. Adolescents who are spending less than 30 minutes per day of his time playing games.
5. Parent of the adolescent giving a written informed consent for participation in the study and the adolescent providing an assent for participation. |
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA FOR GAMERS (MOBA & NON-MOBA)
1. Adolescents with any physical condition or disability that interferes with their participation in the study.
EXCLUSION CRITERIA FOR NON GAMERS (MOBA & NON-MOBA)
1. Adolescents with any physical condition or disability that interferes with their participation in the study. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the prevalence of Internet Gaming Disorder (IGD) among the MOBA adolescent gamers. |
At baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the motivations to play & social connectedness among the Multiplayer Online Battle Arena (MOBA) adolescent gamers & the non MOBA adolescent gamers. |
Baseline |
| To compare the levels of anxiety, depression & loneliness among the Multiplayer Online Battle Arena (MOBA) adolescent gamers & the non MOBA adolescent gamers. |
Baseline |
| To assess the association of gaming & clinical characteristics with the levels of depression & anxiety among the Multiplayer Online Battle Arena (MOBA) adolescent gamers. |
4 weeks
|
| To compare the levels of anxiety, depression & loneliness among the adolescent gamers & non-gamers. |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="1500"
Sample Size from India="1500"
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)
|
21/08/2023 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Internet games are one of the leading forms of entertainment. The patients of Internet Gaming Disorder are associated with psychological distress and poor sleep quality. After the COVID pandemic, adolescents were found to be more affected than adults and it showed more impact on youth mental health. The exact psychological effects of long term playing of Multiplayer Online Battle Arena(MOBA) games is not known. Some studies associate it with increasing risk of mental disorders while some studies link this to leadership developmental qualities. Hence, this study aims to estimate the prevalence of Internet Gaming Disorder among the adolescent gamers playing Multiplayer Online Battle Arena(MOBA) games, recognize their motives to play and understand the impact on their mental health. This study will also compare the motivations to play and social connectedness among MOBA adolescent games, the non-MOBA adolescent gamers, to compare the levels of anxiety, depression, loneliness among the two groups, and to assess the levels of anxiety, depression and loneliness among adolescent gamers and non-gamers. |