| CTRI Number |
CTRI/2024/02/063144 [Registered on: 26/02/2024] Trial Registered Prospectively |
| Last Modified On: |
24/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
This study is being done to compare the stress and workload among nurses working in ICU and non ICU ( Operation theatre, wards ) |
|
Scientific Title of Study
|
A comparative observational study to assess burnout and stress among nursing officers in ICU and non-ICU settings in a tertiary care hospital. |
| 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 Prashant Kumar |
| Designation |
Professor |
| Affiliation |
Pt B D Sharma postgraduate institute of medical sciences, Rohtak |
| Address |
Department of Anaesthesiology & Critical Care Pt B D Sharma postgraduate institute of medical sciences, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9416336901 |
| Fax |
|
| Email |
Pk.pgims@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha |
| Designation |
Junior resident |
| Affiliation |
Pt B D Sharma PGIMS, Rohtak |
| Address |
Department of Anaesthesiology & Critical Care Pt B D Sharma PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9467802605 |
| Fax |
|
| Email |
nehagoyal314@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha |
| Designation |
Junior resident |
| Affiliation |
Pt B D Sharma PGIMS, Rohtak |
| Address |
Department of Anaesthesiology & Critical Care Pt B D Sharma PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9467802605 |
| Fax |
|
| Email |
nehagoyal314@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional, Pt B D Sharma PGIMS, Rohtak |
|
|
Primary Sponsor
|
| Name |
Pt BD Sharma University of Health and Sciences PGIMS Rohtak Haryana |
| Address |
Pt BD Sharma University of Health and Sciences PGIMS,Rohtak,Haryana |
| 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 |
| Dr Neha |
Pt B D Sharma postgraduate institute of medical sciences, Rohtak |
Department of anaesthesiology and critical care
Rohtak
HARYANA |
9467802605
nehagoyal314@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical research ethics committee Pt B D Sharma PGIMS/ UHS, Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
MEDICAL |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All nursing officers working in ICU and non-ICU settings for 6 months or more and willing to participate in the study will be included in study |
|
| ExclusionCriteria |
| Details |
1.All nursing officers not willing to participate
2.Healthcare professionals with history of psychiatric illness or mood disorder. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of burnout and stress in nursing officers working in ICU |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Degree of burnout & stress by using PSS-10 & MBI & their impact on efficiency.
2.Level of stress & burnout in ICU & non ICU healthcare professionals. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/03/2024 |
| Date of Study Completion (India) |
23/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Healthcare institute have a high prevalence of occupational stress.Healthcare workers are exposed to numerous stress provoking situations in their work environment which leads to utmost level of stress and burnout affecting their daily activities also.My purpose of study is to assess stress level prevalence among ICU and non icu nurses.To assess which group is more exposed to stress. |