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CTRI Number  CTRI/2025/11/098186 [Registered on: 28/11/2025] Trial Registered Prospectively
Last Modified On: 27/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Medical Education]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of traditional and Virtual Reality enhanced Temporal bone dissection methods in a cohort of postgraduate students in ENT : A prospective assessor blinded Randomized controlled trial 
Scientific Title of Study   Skill acquisition in temporal bone dissection: Comparing traditional and virtual reality enhanced methods in a postgraduate cohort - a prospective assessor blinded 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  Salil Kumar Gupta 
Designation  Associate Professor 
Affiliation  Govt of India 
Address  Dept of ENT 1st Floor Golden Jubilee Block Armed Forces Medical College Near Wanowadi Police Station

Pune
MAHARASHTRA
411040
India 
Phone  9049379534  
Fax    
Email  afmcitesalil@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Salil Kumar Gupta 
Designation  Associate Professor 
Affiliation  Govt of India 
Address  Dept of ENT 1st Floor Golden Jubilee Block Armed Forces Medical College Near Wanowadi Police Station


MAHARASHTRA
411040
India 
Phone  9049379534  
Fax    
Email  afmcitesalil@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Salil Kumar Gupta 
Designation  Associate Professor 
Affiliation  Govt of India 
Address  Dept of ENT 1st Floor Golden Jubilee Block Armed Forces Medical College Near Wanowadi Police Station


MAHARASHTRA
411040
India 
Phone  9049379534  
Fax    
Email  afmcitesalil@gmail.com  
 
Source of Monetary or Material Support  
Armed Forces Medical College, Solapur Road, Wanowrie, Pune (Maharashtra), India - 411040 
 
Primary Sponsor  
Name  Armed Forces Medical College 
Address  Solapur Road, Wanowrie, Pune, Maharashtra, India - 411040 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 Salil Kumar Gupta  Armed Forces Medical College  Department of ENT, Solapur Road, Wanowrie, Pune (Maharashtra), India - 411040
Pune
MAHARASHTRA 
9049379534

afmcitesalil@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Armed Forces Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Surgical skill development among post graduation students in ENT 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Traditional cadaveric bone dissection  In this arm, Cadaveric temporal bone dissection (as gold standard) for developing Surgical skills in ENT postgraduate training will be compared with intervention arm of additional virtual reality temporal bone dissection  
Intervention  Virtual Reality temporal bone dissection  In this arm, Virtual Reality temporal bone dissection method will be added with traditional cadaveric temporal bone dissection (as gold standard) to see if this addition generates better acquistion of surgical skills  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ENT postgraduation residents with 18 months of completed training and no prior experience in virtual reality temporal bone dissection 
 
ExclusionCriteria 
Details  ENT postgraduation residents with less than 18 months of completed training. ENT residents with prior experience in virtual reality temporal bone dissection 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the improvement in temporal bone dissection skills between residents trained using traditional cadaveric dissection alone and those trained with a combination of VR simulation and cadaveric dissection.  Modified Welling Scores will be given immediately after students perform cadaveric temporal bone dissection 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the time taken to achieve predefined surgical milestones in both groups.  Time will be assessed during cadaveric temporal bone dissection 
To assess the confidence & perceived competence of residents before & after training using modified Objective Structured Assessment of Technical Skills (OSATS) based confidence scale.  Immediately before & immediately after cadaveric temporal bone dissection.  
To evaluate the inter-rater reliability of objective skill assessments using validated scoring tools.  Immediately after cadaveric temporal bone dissection 
 
Target Sample Size   Total Sample Size="18"
Sample Size from India="18" 
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)   25/12/2025 
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="6"
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 - 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 - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

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

  6. For how long will this data be available start date provided 30-01-2026 and end date provided 30-01-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Title: SKILL ACQUISITION IN TEMPORAL BONE DISSECTION   COMPARING TRADITIONAL AND VIRTUAL REALITY ENHANCED METHODS IN A POSTGRADUATE COHORT – A PROSPECTIVE ASSESSOR BLINDED RANDOMIZED CONTROLLED TRIAL.

1. NEED FOR STUDY
Introduction
Temporal bone dissection is a cornerstone of otologic surgical training. Traditionally, cadaveric temporal bone dissection has been the gold standard in teaching otorhinolaryngology ENT residents the complex threedimensional anatomy of the temporal bone and developing their microsurgical skills. However, the efficacy of traditional cadaveric training is increasingly being challenged by multiple constraints, including
1.         Scarcity of cadaveric specimens Due to ethical, legal, and logistic challenges, availability of cadaveric temporal bones is diminishing globally.
2.         High costs and maintenance Setting up and maintaining cadaveric labs is financially demanding.
3.         Lack of objective feedback Traditional cadaveric dissection does not inherently provide realtime feedback to trainees.
4.         Limited supervision time The growing clinical responsibilities of faculty reduce the time available for handson supervision and feedback.
Need for Virtual Reality VR Simulation
Virtual reality temporal bone simulators have emerged as a potential adjunct to traditional methods. These simulators
            Offer a standardized and reproducible learning environment
            Allow selfdirected learning with realtime feedback
            Enable repetitive practice without risking patient safety or exhausting physical resources
            Help trainees develop a threedimensional understanding of complex anatomy
Deficiency in Traditional Methods
Despite being the standard, traditional cadaveric temporal bone dissection training lacks measurable interactivity and scalability. Trainees often develop inadequate or unsafe techniques due to the absence of structured, objective guidance. This results in inefficient use of limited cadaveric resources and slower progression to surgical competence.
Rationale for Study
This study aims to evaluate whether incorporating VRbased simulation into ENT residents training can enhance the effectiveness of cadaveric dissection.
2.  REVIEW OF LITERATURE
Temporal bone dissection has long served as the cornerstone of otologic surgical training. Introduced in the early 20th century, cadaveric dissection allowed postgraduate residents to acquire handson experience in understanding the complex threedimensional anatomy of the temporal bone and refining microsurgical skills essential for ear surgery. Over decades, it evolved into the gold standard for otologic training, particularly for procedures such as cortical mastoidectomy and facial nerve decompression, due to its high anatomical fidelity and tactile realism.
However, the traditional model faces increasing limitations. The availability of cadaveric temporal bones is diminishing globally due to ethical, legal, and logistical constraints. High costs of lab maintenance, disposal protocols, and equipment requirements further limit access. Compounding the problem, the number of postgraduate trainees is rising, while faculty time for individualized supervision is decreasing due to mounting clinical and administrative duties. These factors compromise the effectiveness of cadaveric training, reducing opportunities for repetitive practice and structured feedback.
To overcome these barriers, virtual reality VR simulation has emerged as a valuable adjunct in surgical education. VRbased temporal bone simulators replicate otologic procedures in immersive, interactive environments and allow repeated practice without using physical specimens. They offer automated feedback, facilitate selfdirected learning, and enable consistent exposure to complex anatomy. Several studies have shown that trainees using VR simulation exhibit improved anatomical recognition, faster dissection times, and higher selfconfidence compared to those trained via cadaveric methods alone.
In this context, integrating VR with traditional cadaveric training may enhance skill acquisition, especially in resourcelimited or highvolume academic centres. It offers a scalable and reproducible training tool to bridge gaps in current surgical education models.
3.  OBJECTIVES OF STUDY
i           Primary objective
To compare the improvement in temporal bone dissection skills between residents trained using traditional cadaveric dissection alone and those trained with a combination of VR simulation and cadaveric dissection.
ii           Secondary objectives
a          To assess the time taken to achieve predefined surgical milestones in both groups.
b          To assess the confidence and perceived competence of residents before and after training using modified Objective Structured Assessment of Technical Skills OSATS based confidence scale.
c          To evaluate the interrater reliability of objective skill assessments using validated scoring tools.
4.  MATERIALS AND METHODS
i Source of data
Data will be collected during the conduct of the trial.
ii Methods of collection of data
a Study design  A prospective, randomized, assessorblinded, randomized controlled trial.
b Study period August 2025 to January 2026.
c Sample size Study involves all postgraduation residents total population with 18 months of completed training. Available residents during study period are estimated to be 18 and will be randomized to two groups, 9 per group.
d Place of study Armed forces Medical College, Pune
e Inclusion Criteria
Otorhinolaryngology postgraduation residents total population with 18 months of completed training
f Exclusion Criteria
All others than those in inclusion criteria.
g Methodology
All PG Residents included in study will receive a traditional didactic lecture by Faculty on nuances of temporal bone dissection of 1 hour duration. Thereafter, they will be randomized into two groups  Augmented Training AT and Traditional Training TT.
            AT Group
o          Performs two VR simulations of temporal bone dissection.
o          Performs one selfdirected cadaveric temporal bone dissections
o          Assessed using Modified Welling Scores MWS by two blinded experts  ATCTB  Format for Modified Welling Score att as Appx A.
            TT Group
o          Performs selfdirected cadaveric dissection only.
Assessed using Modified Welling Score MWS by two blinded experts   TTCTB
For primary objective  Intergroup comparison ATCTB  vs TTCTB  Independent ttest or MannWhitney U
For secondary objective 1  Cadaveric temporal dissection procedure will be divided into key steps. Two blinded assessors will record time using digital stopwatches for each step during dissection. Time taken will then be compared among two groups format of time recording sheet is att as Appx B.
For secondary objective 2  A 09 point questionnaire based on modified OSATS based confidence scale has been prepared covering both global as well as task specific OSATS att as Appx C. All points will be scored on a 5point Likert scale ranging from 1  not confident to 5  extremely confident.
All participants will selfassess their confidence scores before and after dissection. Mean scores of both groups will be compared.
For secondary objective 3  Interrater reliability will be checked using Twoway randomeffects model and level of agreement will be assessed.
h Statistical analysis
Group comparison of Modified Welling Scores will be performed using an independent samples ttest or MannWhitney U test if data are nonnormally distributed.
Pre and posttraining confidence scores will be compared using paired ttests or Wilcoxon signedrank test.
Time to task completion will be analysed using appropriate comparative statistics.
Interrater reliability for expert assessors will be calculated using the Intraclass Correlation Coefficient ICC.
A pvalue  0.05 will be considered statistically significant.


 
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