| CTRI Number |
CTRI/2025/02/081014 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Occupational stress and Sleep quality among Nightshift Information Technology workers in Bengaluru |
|
Scientific Title of Study
|
Occupational stress and Sleep quality among Nightshift Information Technology workers in Bengaluru: A Cross-Sectional 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 |
Swathika S |
| Designation |
Postgraduate Student |
| Affiliation |
K. S. Hegde Medical Academy, Nitte (Deemed to be University) |
| Address |
Department of Public Health,
K.S. Hegde Medical Academy,
Nitte(Deemed to be University),
Nithyananda nagar, Derlakatte,
Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9499901160 |
| Fax |
|
| Email |
swamiswathika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mackwin Dmello |
| Designation |
Associate Professor |
| Affiliation |
K. S. Hegde Medical Academy, Nitte (Deemed to be University) |
| Address |
Department of Public Health,
K.S. Hegde Medical Academy,
Nitte(Deemed to be University),
Nithyananda nagar, Derlakatte,
Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9844460590 |
| Fax |
|
| Email |
mackwin@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mackwin Dmello |
| Designation |
Associate Professor |
| Affiliation |
K. S. Hegde Medical Academy, Nitte (Deemed to be University) |
| Address |
Department of Public Health,
K.S. Hegde Medical Academy,
Nitte(Deemed to be University),
Nithyananda nagar, Derlakatte,
Mangaluru
KARNATAKA
575018
India |
| Phone |
9844460590 |
| Fax |
|
| Email |
mackwin@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Public Health, K.S. Hegde Medical Academy, Nitte(Deemed to be University), Nithyananda nagar, Derlakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Mackwin Dmello |
K S Hegde Medical Academy |
Department of Public Health, K.S. Hegde Medical Academy, Nitte(Deemed to be University), Nithyananda nagar, Derlakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India
Dakshina Kannada
KARNATAKA |
9844460590
mackwin@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| K.S. Hegde Medical Academy, Nitte(Deemed to be University) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No specific condition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil
It is a observational study |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Night shift information technology workers aged 21- 60yrs working between 5 PM to 4 AM |
|
| ExclusionCriteria |
| Details |
Non information technology sector workers will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Occupational stress among night shift information technology workers
Sleep quality of night shift information technology workers
|
2 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Association between occupational stress & sleep quality among nightshift information technology workers
|
2 Months |
|
|
Target Sample Size
|
Total Sample Size="633"
Sample Size from India="633"
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)
|
03/03/2025 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 study aims to determine the prevalence of occupational stress, level of sleep quality and the association of occupational stress and sleep quality among nightshift information technology workers in Bengaluru. It is a cross sectional study. Night shift information technology workers aged 21 - 60yrs who were present at the time of conducting the data collection period. The data collection period will be from March 2025- April 2025. Questionnaires include occupational stress index(OSI) for assessing occupational stress and Pittsburg Sleep Quality Index(PSQI) for assessing the sleep quality . he questionnaires which were not completed will be rejected. Data entry will be done on Microsoft Excel which will be collected through Epicollect5 and for analysis it will be exported to Jamovi 2.3.28. Data will be expressed in frequency percentage. Chi square test will be used to find the association between occupational stress and sleep quality. P <0.05 will be considered statistically significant. The assessed results will be helpful for future studies too. |