| 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
|
|
|
Primary Sponsor
|
| Name |
Department of ENT, AFMC |
| Address |
Armed Forces Medical College, Pune, Maharashtra |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
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
|
|
|
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. |
|
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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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- 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
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sukritbindal747@gmail.com].
- 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.
- 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. |