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CTRI Number  CTRI/2025/04/084170 [Registered on: 04/04/2025] Trial Registered Prospectively
Last Modified On: 03/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Cluster Randomized Trial 
Public Title of Study   Study on the Hello Bundle Intervention to Reduce Burnout in ICU Healthcare Workers. 
Scientific Title of Study   Protocol for a Cluster Randomized Controlled Trial Evaluating the Effectiveness of the Hello Bundle Intervention in Reducing Burnout among ICU Healthcare Professionals. 
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 Ashish Bindra 
Designation  Professor 
Affiliation  AIIMS, NEW DELHI 
Address  Room No 118, Office Block, JPNA Trauma Centre, AIIMS
Jai Prakash Narayan Apex Trauma Centre
South
DELHI
110029
India 
Phone  8826417127  
Fax    
Email  dr_ashi2208@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashish Bindra 
Designation  Professor 
Affiliation  AIIMS, NEW DELHI 
Address  Room No 118, Office Block, JPNA Trauma Centre, AIIMS
Jai Prakash Narayan Apex Trauma Centre
South
DELHI
110029
India 
Phone  8826417127  
Fax    
Email  dr_ashi2208@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Ashish Bindra 
Designation  Professor 
Affiliation  AIIMS, NEW DELHI 
Address  Room No 118, Office Block, JPNA Trauma Centre, AIIMS
Jai Prakash Narayan Apex Trauma Centre
South
DELHI
110029
India 
Phone  8826417127  
Fax    
Email  dr_ashi2208@yahoo.com  
 
Source of Monetary or Material Support  
Jai Prakash Narayan Apex Trauma Centre (JPNATC) ,All India Institute of Medical Sciences (AIIMS), New Delhi-110029, Delhi,India  
 
Primary Sponsor  
Name  Elie Azoulay 
Address  Professor Elie Azoulay Head of the Intensive Care Medicine and Resuscitation Department, Saint-Louis Hospital, APHP, University of Paris President of the European Society of Intensive Care Medicine European Society of Intensive Care medicine (ESICM)- 19 Rue Belliard, BE-1040 Brussels  
Type of Sponsor  Other [N/A] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Ashish Bindra  Room No. 118, First Floor, Faculty Block, JPNA Trauma Centre, AIIMS, New Delhi 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashish Bindra  Jai Prakash Narayan Apex Trauma Center   Room No 118, Office Block, Jai Prakash Narain Apex Trauma Centre Jai Prakash Narain Apex Trauma Centre
South
DELHI 		 8826417127

dr_ashi2208@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE AIIMS DELHI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Nil 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hello Bundle  The intervention comprises of various components aimed at fostering a positive and supportive work environment, including the distribution of Hello Campaign Posters, Email Reminders, Morning Huddles, Hello Jars, and Lead by Example initiatives. A hello board updated daily will be made available in each ICU. This will be done in 4 weeks 
Comparator Agent  Standard Practice  No hello intervention will be done 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  Consenting ICUs participating in the Hello trial, each including 50 Healthcare Providers. 
 
ExclusionCriteria 
Details  Non consenting participant
ICUs with less than 50 healthcare providers 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Symptoms of burnout will be measured using the validated version of the 22-item Maslach Burnout Inventory (MBI, Human Services version),which includes three subscales: emotional exhaustion (9 items), depersonalization(5 items),and personal accomplishment(8 items).Each item is scored from 0(never)to 6(every day).Respondents with high emotional exhaustion(greater than or equal to 27)and/or high depersonalization(greater than or equal to 10)scores will be considered to have symptoms of burnout.  Baseline 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
satisfaction with work, HCPs intent to leave the ICU, & ethical climate rank.  4 weeks 
 
Target Sample Size   Total Sample Size="7300"
Sample Size from India="2450" 
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)   14/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  14/04/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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   Professional burnout among intensive care healthcare professionals is a major concern with implications both at the individual level and at the level of the quality of care delivered to patients. This protocol describes a cluster randomized controlled trial designed to evaluate the effectiveness of an intervention consisting of encouraging healthcare professionals in intensive care to say “hello” to each other. The intervention includes several components aimed at fostering a positive and supportive work environment, including the distribution of Hello campaign posters, email reminders, morning meetings, message boxes and leadership initiatives by the example set by department heads and nursing executives. Finally, a board on which caregivers can exchange messages of sympathy will be available. The trial will involve 146 participating centers affiliated with ESICM, randomly allocated between intervention and control groups. French centers will be part of the study. Each center must include on average 50 (between 25 and 100) health professionals (doctors, nurses, caregivers, physiotherapists, psychologists, dietitians, etc.). The professional burnout score (MBI) will be collected one month before and one month after the intervention. Data on caregiver satisfaction, professionals’ intention to leave intensive care and perceptions of the ethical climate will also be collected. No patient or family data will be collected. The statistical analysis will compare the results between the intervention and control groups, aiming to demonstrate a reduction in the prevalence of burnout from 40% to 30% with an intra-class coefficient of 0.3 and statistical power by 90%. This trial has the potential to provide valuable information on effective strategies to prevent burnout in intensive care, ultimately benefiting both healthcare professionals and patients. 
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