| 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 |
|
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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
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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 |
|
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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 |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
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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 |
|
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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 |
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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 - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [afmcitesalil@gmail.com].
- 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.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
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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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