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CTRI Number  CTRI/2025/08/092849 [Registered on: 12/08/2025] Trial Registered Prospectively
Last Modified On: 11/08/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Mixed method study 
Study Design  Other 
Public Title of Study   Designing and validation of a trauma team training simulation module 
Scientific Title of Study   Desgining and validation of an interprofessional trauma team training simulation module in a tertiary care teaching 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 Sanjan Asanaru kunju 
Designation  Associate Professor 
Affiliation  KMC Mangalore 
Address  Department of Emergency Medicine, Kasturba Medical college, Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  09447978877  
Fax    
Email  sanjan.asanar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjan Asanaru kunju 
Designation  Associate Professor 
Affiliation  KMC Mangalore 
Address  Department of Emergency Medicine, Kasturba Medical college, Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  09447978877  
Fax    
Email  sanjan.asanar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sanjan Asanaru kunju 
Designation  Associate Professor 
Affiliation  KMC Mangalore 
Address  Department of Emergency Medicine, Kasturba Medical college, Mangalore

Dakshina Kannada
KARNATAKA
575001
India 
Phone  09447978877  
Fax    
Email  sanjan.asanar@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Dr Sanjan Asanaru Kunju 
Address  Department of Emergency Medicine, Kasturba Medical college, Mangalore, Dakshina Kannada, Karnataka Pin 575001 
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 Sanjan Asanaru kunju  KMC Mangalore  Dept of Emergency Medicine, KMC Mangalore
Dakshina Kannada
KARNATAKA 		 09447978877

sanjan.asanar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical college Mangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Experts from Emergency Medicine, Orthopedics, surgery, anesthesia, allied health, nurses, and interns  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Participants (excluding interns) should be experienced healthcare professionals, educators, or faculty members from fields relevant to trauma care (e.g., emergency medicine, surgery, Orthopedician, anesthesiologist, clinical forensic medical unit, nursing, respiratory therapy, and emergency medicine technology) to provide informed input on content and structure.

Healthcare professionals should have at least 3 years of experience in their respective fields to ensure they have sufficient background knowledge and practical expertise in trauma care and resuscitation.

Interns from different interprofessional backgrounds who are willing to participate in focus group discussions and survey questionnaires

Participants must be willing to engage actively in the module’s development process, providing feedback on content and assessing module components.

Participants should be available for all planned validation activities, including consensus-building sessions 
 
ExclusionCriteria 
Details  Individuals from specialties who are not directly involved in trauma care may lack the specific expertise needed to inform module content.

Individuals who are unable to commit to all scheduled development and feedback sessions, as their consistent input is crucial for the module’s consensus-building process. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary goal of this module is to improve the patient outcome with the design and validation of an interprofessional simulation-based trauma training module. Specific objectives include developing a simulation-based IP trauma resuscitation module that fosters effective team coordination between doctors, nurses, respiratory therapists, and emergency medicine technicians.  6 months from the date of approval of IEC 
 
Secondary Outcome  
Outcome  TimePoints 
To validate the developed module  3 months 
 
Target Sample Size   Total Sample Size="289"
Sample Size from India="289" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   22/08/2025 
Date of Study Completion (India) 26/12/2025 
Date of First Enrollment (Global)  22/08/2025 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="9"
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   This study aims to design, validate, and refine a simulation-based Interprofessional Trauma Resuscitation Training Module for interns in a tertiary care teaching hospital. The primary purpose is to enhance interprofessional collaboration, team coordination, and clinical decision-making skills in trauma scenarios through structured simulation-based education. The module will be developed using a mixed-methods approach, incorporating focus group discussions, needs assessment surveys, and content validation by trauma care experts. The hypothesis is that a simulation-based, interprofessional trauma resuscitation training module—developed through expert consensus and learner input—will be perceived as valid, relevant, and feasible by both experts and interns, and will address existing gaps in trauma training at the undergraduate level. Ultimately, the module aims to strengthen interprofessional training and improve patient outcomes in real-world trauma care. 
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