| CTRI Number |
CTRI/2025/09/094118 [Registered on: 02/09/2025] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Digital Strain, Sleep, and Stress: Academic Impacts on AIIMS Healthcare Students |
|
Scientific Title of Study
|
Digital Eye Strain, Sleep Quality, Psychological Stress, and Their Impact on Academic Performance Among Healthcare Students at AIIMS Delhi |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjay Kumar Mishra |
| Designation |
Scientist |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No. 145, Dr. R. P. Centre for Ophthalmic Sciences, All India Institute of Medical Sciences (AIIMS), New Delhi
South
DELHI
110029
India |
| Phone |
8802105456 |
| Fax |
|
| Email |
sanjaymishraknp@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjay Kumar Mishra |
| Designation |
Scientist |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No. 145, Dr. R. P. Centre for Ophthalmic Sciences, All India Institute of Medical Sciences (AIIMS), New Delhi
DELHI
110029
India |
| Phone |
8802105456 |
| Fax |
|
| Email |
sanjaymishraknp@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjay Kumar Mishra |
| Designation |
Scientist |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No. 145, Dr. R. P. Centre for Ophthalmic Sciences, All India Institute of Medical Sciences (AIIMS), New Delhi
DELHI
110029
India |
| Phone |
8802105456 |
| Fax |
|
| Email |
sanjaymishraknp@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS, New Delhi |
| Address |
Dr. R. P. Centre for Ophthalmic Sciences, All India Institute of Medical Sciences (AIIMS), New Delhi 110029 |
| 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 |
| Sanjay Kumar Mishra |
AIIMS, Delhi |
Room No. 145, Dr. R. P. Centre for Ophthalmic Sciences, All India Institute of Medical Sciences (AIIMS), New Delhi 110029
South
DELHI |
8802105456
sanjaymishraknp@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institue Ethics Committee, All India Institute of Medical Sciences (AIIMS), New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H359||Unspecified retinal disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Participants must...
1.Be enrolled healthcare students (B.Optom., MBBS, B.Sc. Nursing, M.Sc., MD, DM, MCh, or PhD) at AIIMS Delhi.
2.Have a total digital screen time (academic + non-academic) of more than 2 hours/day.
3.Regularly use digital screens for academic purposes (e.g., online lectures, research, note-taking, assignments).
4.Be willing to provide informed consent and complete the study questionnaire. |
|
| ExclusionCriteria |
| Details |
Participants will be excluded if they-
Have a diagnosed sleep disorder (e.g., insomnia, sleep apnea) or are on medications affecting sleep.
Have a history of significant psychological disor-ders (e.g., severe anxiety, depression) requiring on-going medical treatment.
Have any known ocular pathology (e.g., kerato-conus, retinal disorders) that may affect visual function.
Have undergone refractive surgery or any ocular surgery in the past 6 months.
Use medications affecting vision, sleep, or stress (e.g., antidepressants, sedatives).
Have any neurological conditions that may impact digital screen use or academic performance. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Prevalence and severity of Digital Eye Strain (DES) (CVS-Q score)
Sleep quality (PSQI score)
Psychological stress level (PSS score)
Association of DES, sleep, and stress with academic performance (GPA/self-reported) |
Single cross-sectional assessment at baseline (enrolment, one timepoint) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Prevalence & Severity of Digital Eye Strain Measured through self reported symptoms from the validated questionnaire
Sleep Quality Disturbances Evaluated using self-reported responses on sleep patterns their academic impact
Psychological Stress Key Stressors Assessed based on questionnaire responses identifying academic nonacademic stress factors
Correlations Between Factors Analysis of relationships among digital eye strain sleep disturbances psychological stress & academic performance |
1. All secondary outcomes will be assessed at a single time point during the survey administration (baseline) among participating healthcare students at AIIMS Delhi |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
22/09/2025 |
| 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="1"
Months="0"
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
|
With the increasing reliance on digital devices in academic settings, healthcare students are at heightened risk of digital eye strain (DES), poor sleep quality, and psychological stress. Prolonged screen exposure, demanding coursework, and stress from academic pressures may collectively impact academic performance and overall well-being. This study aims to evaluate the prevalence and severity of digital eye strain, sleep disturbances, and psychological stress among healthcare students at AIIMS Delhi. It will also analyze their combined and independent effects on academic performance using a structured, validated questionnaire. The findings will provide insights into potential interventions to improve student well-being and academic outcomes.
|