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CTRI Number  CTRI/2026/03/106250 [Registered on: 16/03/2026] Trial Registered Prospectively
Last Modified On: 16/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Educational]  
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Comparative Effectiveness of Simulation-Based Learning Versus Traditional Bedside Teaching in Orthopedic Training for Interns in terms of Knowledge gain, skill acquisition and learners confidence. 
Scientific Title of Study   Comparative analysis of Simulation-Based Learning versus Bedside Learning in Orthopaedics Among Undergraduate Intern Medical Students 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Govind Kumar Gupta 
Designation  Professor, Head, Department of Orthopaedics 
Affiliation  Rajendra Institute of Medical Sciences 
Address  Department of Orthopaedics, in front of Prisoners Ward, Basement, Rajendra Institute of Medical Sciences, Bariatu, Ranchi

Ranchi
JHARKHAND
834009
India 
Phone  7979014287  
Fax    
Email  gkgupta1975@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Govind Kumar Gupta 
Designation  Professor, Head, Department of Orthopaedics 
Affiliation  Rajendra Institute of Medical Sciences 
Address  Department of Orthopaedics, Basement, In front of Prisoners ward, Rajendra Institute of Medical Sciences, Bariatu, Ranchi

Ranchi
JHARKHAND
834009
India 
Phone  7979014287  
Fax    
Email  gkgupta1975@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Govind Kumar Gupta 
Designation  Professor, Head, Department of Orthopaedics 
Affiliation  Rajendra Institute of Medical Sciences 
Address  Department of Orthopaedics, Basement, in front of Prisoners Ward, Rajendra Institute of Medical Sciences, Bariatu, Ranchi

Ranchi
JHARKHAND
834009
India 
Phone  7979014287  
Fax    
Email  gkgupta1975@yahoo.co.in  
 
Source of Monetary or Material Support  
Rajendra Institute of Medical Sciences, Ranchi, Jharkhand, PIN:834009, India,  
 
Primary Sponsor  
Name  Govind Kumar Gupta 
Address  Principal Investigator, Professor, Head, Department of Orthopaedics, RIMS, Ranchi, Jharkhand,PIN: 834009, India 
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 
Govind Kumar Gupta  Rajendra Institute of Medical Sciences  Ortho OPD, OPD building, First floor, Rajendra Institute of Medical Sciences, Bariatu, Ranchi
Ranchi
JHARKHAND 		 7979014287

gkgupta1975@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee, Ranchi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Medical interns 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Bedside teaching   Will be conducted in orthopaedic wards/OPD.Same topics covered through traditional bedside methods. Case-based teaching with real patients having fractures or joint pathologies. Demonstration of knee examination, clinical reasoning, and discussion of management.Limited supervised practice of examination/procedural steps as ethically and practically feasible on real patients. (2–3 sessions/week of 1–2 hours each)  
Intervention  Simulation based learning (SBL)   Conducted in skills/lab or designated area. Skills covered will be- Clinical examination of the knee joint on models. Application of above elbow plaster for upper limb immobilisation using synthetic bone models. Application of lower limb skin traction and basic traction principles (e.g. skin traction on model). (2–3 sessions/week of 1–2 hours each)  
 
Inclusion Criteria  
Age From  18.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  MBBS interns currently posted in orthopaedics during the study period.
Students who provide written informed consent
 
 
ExclusionCriteria 
Details  •MBBS interns with prior formal exposure to structured orthopaedic simulation ourses/workshops (beyond routine posting) to avoid bias from previous SBL training.
•MBBS interns who are absent for any of the planned teaching or assessment sessions.
•MBBS interns unwilling to participate or refusing consent.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Knowledge Gain   Baseline, 16 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
Skill Acquisition  Baseline, 16 weeks. 
Learner Satisfaction/Confidence   post 4 months teaching intervention  
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   30/03/2026 
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="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

This prospective, quasi-experimental educational intervention study aims to compare Simulation-Based Learning (SBL) with traditional Bedside Teaching (BT) in orthopaedics among undergraduate medical interns. The study will be conducted at the Department of Orthopaedics, Rajendra Institute of Medical Sciences (RIMS), Ranchi, over four months. A total of 72 MBBS interns posted in orthopaedics will be included and allocated into two groups (36 each) using batch-wise convenience sampling.

Both groups will initially undergo a baseline pre-test assessing knowledge, skill, and self-reported confidence. Group 1 will receive structured SBL sessions using synthetic bone models and Peyton’s four-step approach for key orthopaedic procedures (knee examination, upper-limb plaster application, and lower-limb skin traction). Group 2 will receive conventional bedside teaching on similar topics with real patients in wards/OPD. Post-intervention, both groups will be reassessed using identical MCQs, OSCE-based skill checklists, and satisfaction scales.

Primary outcome: Knowledge gain (based on pre- and post-test MCQ scores).
Secondary outcomes: Skill acquisition and learner confidence/satisfaction (checklist and Likert-scale ratings).

The study anticipates that simulation-based learning will produce greater improvement in knowledge, skill performance, and learner confidence compared to bedside teaching alone. 

 
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