FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/12/099535 [Registered on: 19/12/2025] Trial Registered Prospectively
Last Modified On: 10/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Educational/Surgical simulation training]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of traditional cadaveric temporal bone dissection with traditional method augmnted with virtual reality temporal bone dissection - Randomized controlled trial 
Scientific Title of Study   Integrating Virtual Reality Simulation in Otologic Surgical Training: Comparison of Traditional versus Augmented Training Methods for Temporal Bone Dissection – A Randomized Controlled Trial 
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 SUKRIT BINDAL 
Designation  Post graduation trainee 
Affiliation  ARMED FORCES MEDICAL COLLEGE 
Address  Department of ENT, ARMED FORCES MEDICAL COLLEGE, solapur Road, Wanawadi, PUNE, MAHARASHTRA, India

Pune
MAHARASHTRA
411040
India 
Phone  7082774424  
Fax    
Email  sukritbindal747@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Salil Kumar Gupta 
Designation  Associate Professor  
Affiliation  Armed forces medical college 
Address  Department of ENT, Armed forces medical college, Solapur road, Wanowrie, Pune

Pune
MAHARASHTRA
411040
India 
Phone  9049379534  
Fax    
Email  afmcitesalil@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sukrit Bindal 
Designation  Post graduation trainee 
Affiliation  Armed forces medical college 
Address  Department of ENT, Armed forces medical college, solapur road, wanowrie, pune

Pune
MAHARASHTRA
411040
India 
Phone  7082774424  
Fax    
Email  sukritbindal747@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Department of ENT, AFMC 
Address  Armed Forces Medical College, Pune, Maharashtra 
Type of Sponsor  Government 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 
SUKRIT BINDAL  Armed forces medical college  Department of ENT, solapur road, wanowrie, pune, maharashtra, india
Pune
MAHARASHTRA 
07082774424

sukritbindal747@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AFMC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Development of surgical skills in ENT PG residents 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Traditional cadaveric temporal bone dissection  Traditional cadaveric temporal bone dissection will be compared with VR temporal bone dissection as an adjunct in intervention arm. 
Intervention  Virtual reality temporal bone dissction  Virtual reality temporal bone dissection will be added with traditional cadaveric temporal bone dissection 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  ENT Residents with no prior formal temporal bone dissection experience. 
 
ExclusionCriteria 
Details  ENT Residents with prior formal temporal bone dissection experience. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the effectiveness of augmented training (VR + cadaveric temporal bone dissection) with traditional cadaveric temporal bone dissection training alone on performance of cortical mastoidectomy in live patients using a validated Task-based checklist for objective assessment.  Phase I Analysis:
Inter-group comparison: AT-CTB I vs TT-CTB I (Independent t-test or Mann–Whitney U)
 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare the cadaveric dissection skills between two groups following initial training using Modified Welling Score (MWS)
2. To correlate MWS score from cadaveric dissection in Phase I with Task based Checklist (TBC Score) from surgery on actual patient in phase II
 
Phase I Analysis:
Inter-group comparison: Phase I vs Phase II 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
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)   01/01/2026 
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="1"
Months="6"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sukritbindal747@gmail.com].

  6. For how long will this data be available start date provided 30-05-2027 and end date provided 30-05-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Temporal bone dissection is a cornerstone of otologic surgical training serving as the primary means for residents in otorhinolaryngology to acquire detailed knowledge of the complex three dimensional anatomy of the temporal bone and to develop the fine microsurgical skills necessary for safe and effective ear surgery. Traditionally cadaveric temporal bone dissection has been regarded as the gold standard for such training, offering realistic tactile feedback and anatomical fidelity unmatched by other modalities.

 Despite these strengths, reliance solely on cadaveric training presents several limitations scarcity of cadaveric specimens, high procurement and maintenance costs for dissection laboratories biohazard risks and constraints on faculty supervision time. Furthermore, cadaveric dissection lacks inherent mechanisms for objective performance assessment limiting structured feedback for trainees.

 Advances in educational technology have led to the development of virtual reality (VR) based temporal bone simulators which offer a standardized and reproducible environment for surgical training. These systems integrate three-dimensional visual rendering with haptic feedback to replicate the drilling and handling experience of temporal bone surgery. Unlike cadaveric training VR simulators allow repetitive practice without degradation of materials enable deliberate practice at the learner’s own pace, and provide automated, objective feedback metrics to monitor progress. Importantly VR simulation eliminates ethical and logistical issues associated with human tissue use while offering adjustable difficulty levels and scenarios to match the learner’s skill progressio.

 Multiple randomized controlled trials have demonstrated that VR simulation can significantly improve temporal bone dissection performance particularly in novice trainees. Andersen et al. found that residents who underwent self-directed VR mastoidectomy training demonstrated superior dissection skills compared to those trained traditionally with benefits persisting in subsequent cadaveric dissections. Zhao et al. reported that VR trained participants achieved higher scores in objective assessments highlighting the potential of simulation to shorten the learning curve and improve technical competence before live surgery. Furthermore VR training has been shown to reduce cognitive load, allowing trainees to focus on the acquisition of surgical strategy and precision.

 Despite these promising results, most training programs continue to rely heavily on cadaveric dissection with VR simulation serving as an adjunct rather than an integrated component of the curriculum. The optimal way to combine these modalities remains unclear. Specifically, there is a paucity of data on whether VR augmented training translates into improved operative performance in live patients beyond its effects on simulation and cadaveric tasks. As surgical education increasingly moves towards competency-based frameworks the need for structured, measurable and scalable training interventions becomes imperative.

This study seeks to address these gaps by conducting a randomized controlled trial comparing traditional cadaveric temporal bone dissection with an augmented program integrating VR simulation at multiple stages of training.

The primary objective is to evaluate whether VR augmented training improves cortical mastoidectomy performance in live patients assessed using validated task-based checklists. Secondary objectives include examining inter and intra group progression across training phases, correlating VR system scores with cadaveric performance (Modified Welling Scores) and assessing the impact of early VR exposure on the learning curve.

 By systematically integrating VR simulation into otologic surgical training and evaluating its real world impact, this research aims to contribute evidence based recommendations for modernizing temporal bone dissection curricula. Ultimately findings from this study could support a shift towards blended training models that maximize skill acquisition improve patient safety and optimize resource utilization in otologic surgical education.

 
Close