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CTRI Number  CTRI/2025/02/081010 [Registered on: 20/02/2025] Trial Registered Prospectively
Last Modified On: 18/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Behavioral 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Simulation based teaching for residents in anaesthesiology- study to assess the need and curriculum development 
Scientific Title of Study   Development, Implementation and Evaluation of a Simulation based curriculum for Residents in Anaesthesiology 
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 Divya VIncent 
Designation  Assistant Professor 
Affiliation  Father Muller Medical College 
Address  Department of Anaesthesiology Father Muller Medical College Kankanady Mangalore

Dakshina Kannada
KARNATAKA
575006
India 
Phone  8971023187  
Fax    
Email  djrexvin@fathermuller.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Divya VIncent 
Designation  Assistant Professor 
Affiliation  Father Muller Medical College 
Address  Department of Anaesthesiology Father Muller Medical College Kankanady Mangalore

Dakshina Kannada
KARNATAKA
575006
India 
Phone  8971023187  
Fax    
Email  djrexvin@fathermuller.in  
 
Details of Contact Person
Public Query  
Name  Dr Divya VIncent 
Designation  Assistant Professor 
Affiliation  Father Muller Medical College 
Address  Department of Anaesthesiology Father Muller Medical College Kankanady Mangalore

Dakshina Kannada
KARNATAKA
575006
India 
Phone  8971023187  
Fax    
Email  djrexvin@fathermuller.in  
 
Source of Monetary or Material Support  
Father Muller Medical College, Mangalore,karnataka, Mangalore, India 575002 
 
Primary Sponsor  
Name  Father Muller Medical College 
Address  Father Muller Medical College road Kankanady, Mangalore, India 575002 Mangalore 
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 Divya  Father Muller Medical College   Department of Anaesthesiology, Room number 2, basement 2,Kankanady main road, Mangalore 575002
Dakshina Kannada
KARNATAKA 		 8971023187

djrexvin@fathermuller.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Father Muller institutional ethics committee  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  Implementation of simulation curriculum   teaching simulation based curriculum in addition to traditional teaching 
Comparator Agent  Traditional teaching  assessing traditional way of managing an anesthetic scenario 
 
Inclusion Criteria  
Age From  22.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  All 27 residents from the department will be included 
 
ExclusionCriteria 
Details  Any resident absent for more than half the sessions will be excluded from the study.
any resident who doesnt complete each lesson will be excluded from the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Ensuring that all technical(procedural skills) and non technical skills(communication and decision making) will improve
 		 assessed every month through training based on simulation for two years 
 
Secondary Outcome  
Outcome  TimePoints 
To assess if the students are practice ready
 		 every month assessment for two years 
 
Target Sample Size   Total Sample Size="27"
Sample Size from India="27" 
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)   01/05/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Closed to Recruitment of Participants 
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 addresses the absence of a structured Simulation Based Training (SBT) curriculum for Anaesthesiology residents in India by developing, implementing, and evaluating such a curriculum. It aims to identify competencies best achieved through SBT, understand implementation barriers, and integrate SBT into the residency program. The curriculum will include E-Modules, Skill Sessions, and In-situ simulations. By enhancing resident readiness and patient safety in the operating room, the study aims to publish results in academic journals to aid program implementation and improve patient outcomes. 
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