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CTRI Number  CTRI/2024/10/075724 [Registered on: 23/10/2024] Trial Registered Prospectively
Last Modified On: 26/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Prevalence and stressors of Burnout Syndrome in ICU Nurses: A Study at AIIMS Bhubaneswar  
Scientific Title of Study   A study to assess the prevalence of Burnout Syndrome and its stressors among ICU nurses of AIIMS Bhubaneswar 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mrs Nadiya Krishnan 
Designation  Assistant Professor  
Affiliation  AIIMS, Bhubaneswar  
Address  Room No:- 106 Department:- College of Nursing Devision:- Critical Care Nursing AIIMS Bhubaneshwar, Sijua, Patrapada.

Khordha
ORISSA
751019
India 
Phone  9780472371  
Fax    
Email  con_nadiya@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Raksha Meghwal 
Designation  MSc. Nursing Student 
Affiliation  AIIMS, Bhubaneswar 
Address  Room No:- 205 Department:- College of Nursing Division:- Critical Care Nursing AIIMS Bhubaneswar, Sijua, Patrapada.

Khordha
ORISSA
751019
India 
Phone  8290864007  
Fax    
Email  rakshameghwal99@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Raksha Meghwal 
Designation  Assistant Professor  
Affiliation  AIIMS, Bhubaneswar 
Address  Room No:- 205 Department:- College of Nursing Division:- Critical Care Nursing AIIMS Bhubaneswar, Sijua, Patrapada.

Khordha
ORISSA
751019
India 
Phone  8290864007  
Fax    
Email  rakshameghwal99@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Raksha Meghwal 
Address  Pg1B AIIMS Residential complex, Sijua, Patrapada, Bhubaneswar, Odisha 751019 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Raksha Meghwal  Intensive Care Units of AIIMS Bhubaneswar  Department: Intensive Care Units Division: Critical Care 1st, 3rd, and 4th floor of Hospital Block, Sijua, Patrapada, Bhubaneswar.
Khordha
ORISSA 
08290864007

rakshameghwal99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS Bhubaneshwar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  NA 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Nurses working in the intensive care unit with work experience ≥ 1 year.
2. Nurses who are willing to participate in the survey.

 
 
ExclusionCriteria 
Details  1. Nurses who are on long leave.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Identify the prevalence of Burnout Syndrome among ICU nurses in AIIMS Bhubaneswar.
2. what are the stressors of burnout syndrome that affect ICU nurses.
 
3 Months
 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
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)   11/11/2024 
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="3"
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 titled "A Study to Assess the Prevalence of Burnout Syndrome and Its Stressors Among ICU Nurses of AIIMS Bhubaneswar" aims to evaluate the prevalence of Burnout Syndrome among ICU nurses and identify contributing stressors. Burnout syndrome is defined as chronic physical and emotional exhaustion, detachment, and reduced personal accomplishment, measurable by scores greater than 2.59 on a Burnout Assessment Tool. The research employs a mixed-method approach, consisting of a quantitative phase using total enumerative sampling of all 323 ICU nurses and a qualitative phase utilizing purposive sampling of those scoring between 3.02 and 5.00 to ensure a comprehensive understanding of burnout experiences. Inclusion criteria for the quantitative phase include ICU nurses with at least one year of experience, while qualitative participants must fall into the high burnout category. The findings aim to illuminate the extent of burnout and the specific stressors affecting ICU nurses, contributing valuable insights for improving their well-being and job performance. 
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