| CTRI Number |
CTRI/2025/07/090397 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Impact Of Digital Devices Usage On Mental Health and And Academic Performance Of College Students - A Survey Study |
|
Scientific Title of Study
|
Impact Of Digital Device Usage On Mental Health And Academic Performance Of College Students: A Survey Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pawan Kumar |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
Galgotias University Plot No.2 Yamuna Expressway Opposite Buddha International Circuit, Sector 17A, Greater Noida Uttar Pradesh 203201
Galgotias University Plot No.2 Yamuna Expressway Opposite Buddha International Circuit, Sector 17A, Greater Noida Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
7982233136 |
| Fax |
|
| Email |
pk7210585418@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aksh Chahal |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
Galgotias University Plot No.2 Yamuna Expressway Opposite Buddha International Circuit, Sector 17A, Greater Noida Uttar Pradesh 203201
Galgotias University Plot No.2 Yamuna Expressway Opposite Buddha International Circuit, Sector 17A, Greater Noida Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9711774174 |
| Fax |
|
| Email |
drakshchahal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aksh Chahal |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
Galgotias University Plot No.2 Yamuna Expressway Opposite Buddha International Circuit, Sector 17A, Greater Noida Uttar Pradesh 203201
Galgotias University Plot No.2 Yamuna Expressway Opposite Buddha International Circuit, Sector 17A, Greater Noida Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
7982233136 |
| Fax |
|
| Email |
drakshchahal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of physiotherapy Galgotias university plot no 2 Yamuna Expressway opposite buddh international Circuit sector 17A Greater Noida Uttar Pradesh India 203201 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 Aksh Chahal |
Galgotias University |
Galgotias University Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH |
9711774174
drakshchahal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Research Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mental health |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
College students currently enrolled at Galgotias University. Students who use digital devices like smartphones, laptops, tablets for academic and /or personal purposes. Individuals who are willing to participate and provide informed consent. |
|
| ExclusionCriteria |
| Details |
Students diagnosed with pre-existing psychiatric or neurological disorders. Individuals. Students with physical disabilities affecting their ability to use digital devices. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Perceived stress scale |
4weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Generalized anxiety disorder-7 item scale |
4weeks |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
20/07/2025 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
The present study followed a structured, cross-sectional survey-based methodology to assess the relationship between digital device usage and its impact on mental health and academic performance among college students. Initially, the research problem was formulated based on observed trends in increasing screen time and the rising incidence of mental health issues and academic challenges among university students. A thorough review of existing literature was conducted to identify validated tools and appropriate frameworks for data collection, ensuring the study was grounded in established psychological and educational research paradigms.
Following the literature review, the researchers selected two widely used, validated instruments to assess mental health outcomes—namely, the Perceived Stress Scale (PSS) and the Generalized Anxiety Disorder 7-item Scale (GAD-7). Additionally, a self-designed questionnaire was developed to capture details on academic engagement, digital usage habits, memory retention, productivity, and academic satisfaction. The complete survey instrument was then compiled into a structured form suitable for both digital (Google Forms) and physical administration.
After preparation of the tools, the study protocol and questionnaire were submitted to the institutional ethics committee for review and approval. |