| CTRI Number |
CTRI/2024/04/065388 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
05/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Prevalence of vision disturbance and psychological well-being caused by usage of computers among bank employees |
|
Scientific Title of Study
|
Prevalence of Computer Vision Syndrome and Psychological Wellbeing Among Bank Employees in Mangaluru |
| 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 Baliga Prerana Vineeth |
| Designation |
Post graduate Student |
| Affiliation |
K. S Hegde Medical Academay, Nitte |
| Address |
Department of Public Health
K. S. Hegde Medical Academy Nitte(Deemed to be University) Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9008745653 |
| Fax |
|
| Email |
prerana.baliga@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reni N |
| Designation |
Assistant Professor |
| Affiliation |
K. S Hegde Medical Academay, Nitte |
| Address |
Department of Public Health
K. S. Hegde Medical Academy Nitte(Deemed to be University) Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9447394613 |
| Fax |
|
| Email |
drreni.n@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Reni N |
| Designation |
Assistant Professor |
| Affiliation |
K. S Hegde Medical Academay, Nitte |
| Address |
Department of Public Health
K. S. Hegde Medical Academy Nitte(Deemed to be University) Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9447394613 |
| Fax |
|
| Email |
drreni.n@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| K. S. Hegde Medical Academy Nitte (Deemed to be University) Deralakatte, Mangaluru 575018 |
|
|
Primary Sponsor
|
| Name |
Dr Baliga Prerana Vineeth |
| Address |
Ananthpushp, Next to NMPT Colony, Madhya- Surathkal, Mangalore- 575030 |
| Type of Sponsor |
Other [Primary Investigator ] |
|
|
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 Baliga Prerana Vineeth |
K. S. HEGDE MEDICAL ACADEMY |
K. S. HEGDE
MEDICAL ACADEMY,
NITTE (DEEMED TO
BE UNIVERSITY),
DERALAKATTE,
MANGALURU
Dakshina Kannada 575018
KARNATAKA
Dakshina Kannada
KARNATAKA |
9008745653
prerana.baliga@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| K. S Hegde Medical Academy, Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Bank employees using computers, with work experience of more than 6 months. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Bank employees using computer for more than 6 months |
|
| ExclusionCriteria |
| Details |
Bank employees not using computers for their daily work, employees working less than 6 months, employees with any ocular disorders |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of Computer Vision Syndrome and Psychological well-being among bank employees |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Associated factors of CVS and psychological Well being |
2 months |
|
|
Target Sample Size
|
Total Sample Size="323"
Sample Size from India="323"
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)
|
20/04/2024 |
| 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="2"
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
|
Over the last few decades, the use of computers in our daily lives has increased manyfold. This leaves certain associated risks to us humans. Thus, this study aims to find out the prevalence of computer vision syndrome and psychological well-being among bank employees of urban Mangalore. The sample size calculated is 323, considering the non-response rate. Proportionate and convenient sampling will be done to collect data, in April and May. Categorical variables will be summarized as frequencies and percentages and continuous variables as median. Factors associated will be analysed using the Chi-square or Fisher exact test and multivariable regression analysis will be used to find the correlation. |