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临床试验/CTRI/2025/11/098186
CTRI/2025/11/098186尚未招募不适用

Skill acquisition in temporal bone dissection: Comparing traditional and virtual reality enhanced methods in a postgraduate cohort - a prospective assessor blinded randomized controlled trial

Armed Forces Medical College1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2025年12月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
18
试验地点
1

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Outcome Assessor Blinded

入排标准

年龄范围
25.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • ENT postgraduation residents with 18 months of completed training and no prior experience in virtual reality temporal bone dissection.

排除标准

  • ENT postgraduation residents with less than 18 months of completed training.
  • ENT residents with prior experience in virtual reality temporal bone dissection.

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Salil Kumar Gupta

Govt of India

研究点 (1)

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