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CTRI Number  CTRI/2025/02/080169 [Registered on: 10/02/2025] Trial Registered Prospectively
Last Modified On: 05/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Simulation based teaching of crisis Resource Management (CRM) among Pediatric Residents 
Scientific Title of Study   Impact of teaching simulation based crisis resource management (CRM) A prospective randomized pilot study among pediatric residents 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shivansh Raj Sharma 
Designation  Junior resident 
Affiliation  Department of Pediatrics 
Address  Department of Pediatrics 3rd floor, Himalayan Institute of Medical Sciences
SRHU, Jolly Grant, Swami Ram Nagar
Dehradun
UTTARANCHAL
248016
India 
Phone  8171134300  
Fax    
Email  shivanshraj123@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ashok K Deorari 
Designation  Principal 
Affiliation  Himalayan Institute of Medical Sciences 
Address  Principal Office, University Building, 1st Floor SRHU, Jolly Grant, Swami Ram Nagar

Dehradun
UTTARANCHAL
248016
India 
Phone  9818131391  
Fax    
Email  ashokdeorari@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shivansh Raj Sharma 
Designation  Junior resident 
Affiliation  Himalayan Institute of Medical Sciences 
Address  Department of Pediatrics Library Building, 3rd Floor, SRHU, Jolly Grant, Swami Ram Nagar

Dehradun
UTTARANCHAL
248016
India 
Phone  8171134300  
Fax    
Email  shivanshraj123@gmail.com  
 
Source of Monetary or Material Support  
Himalayan Institute of Medical Sciences, SRHU, Jolly Grant, Swami Ram Nagar, Dehradun 248016, Uttarakhand, India 
 
Primary Sponsor  
Name  Himalayan Institute of Medical Sciences 
Address  Jolly Grant, Dehradun, Uttarakhand 248140 
Type of Sponsor  Private medical college 
 
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 
Dr Shivansh Raj Sharma  Himalayan Institute of Medical Sciences  Department of Pediatrics, 3rd Floor, SRHU, Jolly Grant, Swami Ram Nagar
Dehradun
UTTARANCHAL 
8171134300

shivanshraj123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Himalayan Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  None 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Simulation-based CRM Principles teaching  Structured debriefing on CRM principles one time for seven minutes 
Comparator Agent  Unstructured Feedback  Feedback on CRM Principles one time for five minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  1. Pediatric residents with minimum exposure to Paediatric emergency for at least 8 weeks.
2. Residents who have had at least 8weeks of PICU posting.
3. Emergency room and PICU staff nurses.
 
 
ExclusionCriteria 
Details  1. 2nd year residents who have had their PICU posting in last 8 weeks.
2. Those who refuse to give consent
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary Outcome will be measured by time to intervention and scenario outcome   At baseline immediately after the scenario 
 
Secondary Outcome  
Outcome  TimePoints 
Team Leader performance, team performance using ottawa Global rating score & MAYO high perfmance score  8 weeks after the initial assessment 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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)   17/02/2025 
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="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  

Around 27% of medical errors occur due to communication errors in medical field. Simulation based training allows users at all levels, from novice to expert, to practice and develop skills with their knowledge, and provides a safe, supportive educational environment where mistakes carry no penalties or fear of harm to patients or learners. Crisis resource management, in simple terms are non-technical skills needed for effective teamwork in crisis, ability to translate medical knowledge to real world actions and predicting what all things could happen in immediate future in the setting of an emergency.

Though there are multiple studies looking into effects of teaching crisis resource management skills in medical field, there is a paucity of literature in India. Also there are very few studies examining the retention ability of these skills in healthcare professional. Hence, we would like to conduct this first of its kind experimental study in the country. to determine if including crisis resource management principles during training followed by reflective debriefing would better prepare pediatric residents in managing various crisis situation.

 
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