| CTRI Number |
CTRI/2023/03/050353 [Registered on: 06/03/2023] Trial Registered Prospectively |
| Last Modified On: |
22/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Dependency of online technology in youth of Gohana, Haryana |
|
Scientific Title of Study
|
Digital technology addiction among school going adolescents in Gohana block of district Sonipat, Haryana |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Alka Kumari |
| Designation |
Postgraduate Resident |
| Affiliation |
Bhagat Phool Singh Government Medical College for Women |
| Address |
Department of Community Medicine, Khanpur Kalan, Sonipat, Haryana
Sonipat
HARYANA
131305
India |
| Phone |
9463702794 |
| Fax |
|
| Email |
alkasept95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anita Punia |
| Designation |
Professor |
| Affiliation |
Bhagat Phool Singh Government Medical College for Women |
| Address |
Department of Community Medicine, Khanpur Kalan, Sonipat, Haryana
Sonipat
HARYANA
131305
India |
| Phone |
7056737544 |
| Fax |
|
| Email |
dranitapunia15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anita Punia |
| Designation |
Professor |
| Affiliation |
Bhagat Phool Singh Government Medical College for Women |
| Address |
Department of Community Medicine, Khanpur Kalan, Sonipat, Haryana
Sonipat
HARYANA
131305
India |
| Phone |
7056737544 |
| Fax |
|
| Email |
dranitapunia15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bhagat Phool Singh Government Medical College for Women, Khanpur Kalan, Sonipat, Haryana |
|
|
Primary Sponsor
|
| Name |
Bhagat Phool Singh Government Medical College for Women |
| Address |
Khanpur Kalan, Sonipat, Haryana |
| 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 Alka Kumari |
BPS Government Medical College for Women, Khanpur Kalan, Sonipat, Haryana |
Department of Community Medicine
Sonipat
HARYANA |
9463702794
alkasept95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of Bhagat Phool Singh Government Medical College for Women |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Digital technology addiction |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Both |
| Details |
a. All students of 9th to 12th standard of senior secondary schools present on the day of data collection.
b. Those who will be willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
a. Those where not using internet from last 12 months.
b. Those who will not be able to comprehend.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of digital technology addiction by using Youngs Internet addiction test |
at one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Factors associated with digital technology addiction |
at one year |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= "510"
Final Enrollment numbers achieved (India)="510" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2023 |
| Date of Study Completion (India) |
Date Missing |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [alkasept95@gmail.com].
- For how long will this data be available start date provided 20-12-2024 and end date provided 20-12-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
A A school based cross sectional study will be conducted in 500 students of 13 to 19 years of age selected by multistage random sampling technique from senior secondary schools of Gohana block of district Sonipat, Haryana. This study aims to estimate the prevalence and to determine the factors influencing digital technology addiction among study participants. |