| CTRI Number |
CTRI/2025/08/093171 [Registered on: 18/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A cross sectional study on Work Stress and Sleep Quality Among University Staff |
|
Scientific Title of Study
|
Work-related Stress and Sleep Quality among Teaching and Non-Teaching University Staff – 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 |
Dr D Nikitha Mary Nicoba |
| Designation |
Student |
| Affiliation |
K.S. Hegde Medical Academy |
| Address |
Department of Public Health,
K. S. Hegde Medical Academy, Nitte (Deemed to be university)
Dakshina Kannada
Karnataka
575018
India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
07899924127 |
| Fax |
|
| Email |
nikithanicoba@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Reni N |
| Designation |
Assistant Professor |
| Affiliation |
K.S. Hegde Medical Academy |
| Address |
Department of Public Health,
K. S. Hegde Medical Academy, Nitte (Deemed to be university)
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
09447394613 |
| Fax |
|
| Email |
drreni.n@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr D Nikitha Mary Nicoba |
| Designation |
Student |
| Affiliation |
K.S. Hegde Medical Academy |
| Address |
Department of Public Health,
K. S. Hegde Medical Academy, Nitte (Deemed to be university)
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
07899924127 |
| Fax |
|
| Email |
nikithanicoba@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Public Health, K. S. Hegde Medical Academy, Nitte (Deemed to be university) 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 Reni N |
K.S. Hegde Medical Academy |
Department of Public Health, K.S. Hegde Medical Academy, Derelakate
Dakshina Kannada
KARNATAKA |
09447394613
drreni.n@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 |
Stress and Sleep quality |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Individual working in the institution with a minimum of 1 year of working experience |
|
| ExclusionCriteria |
| Details |
Those who are not able to comprehend and those who are not available on the day of the data
collection are excluded from the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association between occupational stress levels and sleep quality |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • Sleep quality among university staff as measured by Pittsburgh Sleep Quality Index (PSQI) |
15 days |
| • Levels of occupational stress among university staff as measured by Occupational Stress Index |
15 days |
|
|
Target Sample Size
|
Total Sample Size="544"
Sample Size from India="544"
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)
|
10/09/2025 |
| 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="0"
Months="0"
Days="15" |
|
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
|
This cross-sectional study will aim to assess the levels of work-related stress and sleep quality among teaching and non-teaching staff. The objectives will include assessing occupational stress, measuring sleep quality, and analyzing the association between them. The study sample will consist of 544 participants aged 20 years or older, selected using a universal sampling method. Data will be collected using a structured questionnaire comprising socio-demographic information, the Occupational Stress Index (OSI), and the Pittsburgh Sleep Quality Index (PSQI). Descriptive statistics will be used to summarise socio-demographic variables, stress levels, and sleep quality scores. Inferential statistical tests, such as the Chi-square test, Pearson’s correlation, and independent t-tests (or the Mann-Whitney U test, as applicable), will be used to examine associations and differences between groups. The tools will be administered in English and Kannada. No intervention or drug use will be involved. The findings will help enhance understanding of how occupational stress influences sleep quality in academic settings, thereby guiding future workplace wellness initiatives |