| CTRI Number |
CTRI/2025/02/080530 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
05/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Resilience and Work-related Quality of Life among ISRO employees |
|
Scientific Title of Study
|
Resilience and Work-related Quality of Life among ISRO employees at Sriharikota: 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 |
Ashna Mathew |
| Designation |
Post Graduate 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)
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7358621524 |
| Fax |
|
| Email |
mathewashna.ph@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prajwal Jupiter Lobo |
| Designation |
Assistant Professor |
| Affiliation |
K S Hegde medical Academ, Nitte (Deemed to be University) |
| Address |
Department of Public Health,
K. S. Hegde Medical Academy, Nitte (Deemed to be University)
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8828224857 |
| Fax |
|
| Email |
prajwal.lobo@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Prajwal Jupiter Lobo |
| Designation |
Assistant Professor |
| Affiliation |
K S Hegde medical Academ, Nitte (Deemed to be University) |
| Address |
Department of Public Health,
K. S. Hegde Medical Academy, Nitte (Deemed to be University)
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8828224857 |
| Fax |
|
| Email |
prajwal.lobo@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Satish Dhawan Space Centre SHAR |
|
|
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 Binu Mathew |
Satish Dhawan Space Centre |
Satish dhawab memorial hospital, SDSC SHAR, Sriharikota, Andhra Pradesh, 524124
Nellore
ANDHRA PRADESH |
9490426142
binu@shar.gov.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 |
Not Applicable |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil, it is Observational study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Only employees currently employed full-time at SDSC, ISRO, will be eligible to ensure they are fully integrated into the organization’s work environment.
Both permanent and long-term contract (2-3 years) employees with at least 6 months of work
experience will be included to capture a broader perspective of work-related quality of life
among different employment types |
|
| ExclusionCriteria |
| Details |
All those other than scientists/engineers/technical officers under 6 main divisions
Interns and research scholars will be excluded because their temporary association with the organization does not provide sufficient experience or exposure to understand the long-term work-related challenges and benefits fully |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Resilience level among ISRO employees |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| work-related quality of life among ISRO employees |
2 months |
|
|
Target Sample Size
|
Total Sample Size="1450"
Sample Size from India="1450"
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
|
This is descriptive cross-sectional study will be conducted at SDSC, which employs approximately 2120 staff, including 1450 scientists, engineers, and technical officers. Using universal sampling, 90% of this group will be approached, aiming for a sample size of 1450 participants. For data collection, the study will utilize standardized tools—the Brief Resilience Scale (BRS) and the Work-Related Quality of Life (WRQoL) Scale. A mobile-based application (Epicollect5) and paper forms will gather data. Informed consent will be obtained before participation. Data analysis will be conducted using Jamovi version 2.3.28 (or an updated version). Categorical variables will be summarized as frequencies and percentages, while continuous variables will be presented as means (SD) or medians (IQR), depending on data normality. Bivariate logistic regression will assess associations, with statistical significance set at p < 0.05. |