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临床试验/NCT05830786
NCT05830786尚未招募不适用

Effectiveness of Virtual Reality in Orthopaedic Surgical Education: A Multistage Randomized Controlled Trial

University of Toronto0 个研究点目标入组 50 人开始时间: 2023年5月16日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
主要终点
Objective Structured Assessment of Technical Skills (OSATS)

研究概览

简要总结

Immersive virtual reality (IVR) surgical simulators are increasingly being used for learner education. The aim of this randomized controlled trial is to compare the efficacy of IVR to hands-on orthopaedic workshop sessions (such as arthroscopy simulators, cadaveric models, and Sawbones®) in various orthopaedic subspecialties (such as sports, arthroplasty, and spine surgery).

Overall, in this multi-stage comprehensive randomized controlled the aim is to assess:

  1. If IVR simulation using head-mounted displays (HMD) is superior to the current standard of training for orthopaedic surgery residents and medical students.
  2. Determine if it is feasible to incorporate immersive headset virtual reality simulation into residency training programs and medical school curriculums.
  3. Assess the longitudinal application of IVR training on medical student and resident surgical education.

详细描述

Study Stages:

Stage 1 - Medical students and orthopaedic residents participating in the Canadian Orthopaedic Surgery Medical Education Course 2023 (COSMEC) will be selected and computer randomized (1:1) into two groups of experimental (IVR) and control (arthroscopy simulator box), based on level of training. Allocation concealment will be ensured using central randomization. Trainees in both groups will receive a common didactic training for knee arthroscopy. Subsequently, trainees in the experimental group will undergo a IVR surgical training module and trainees in the control group will undergo a similar module using arthroscopy simulator box. Following the training modules, participants will complete knowledge tests, technical skill assessments on knee arthroscopy simulators, and experiential surveys.

Stage 2 - Medical students and orthopaedic residents participating in the 2023 University of Toronto Orthopaedic Surgery bootcamp will be selected and computer randomized (1:1) into two groups of experimental (IVR) and control (sawbones), based on level of training. Allocation concealment will be ensured using central randomization. Trainees in both groups will receive a common didactic training for femoral intramedullary nail (IMN) placement. Subsequently, trainees in the experimental group will undergo a IVR surgical training module and trainees in the control group will undergo a similar module using Sawbones ®. Following the training modules, participants will complete knowledge tests, technical skill assessments on cadaveric models, and experiential surveys.

Stage 3 - The protocol explained in stage 1 and 2 may be repeated for various orthopaedic sub-speciality (including arthroplasty and spine surgery) for the participants in the booth camp.

Stage 4 - All trainees may then be followed longitudinally over the course 6 months. Trainees' performance may be evaluated for procedures in which training was provided, based on preceptor evaluations (for example by completing standardised evaluation forms) on a voluntary basis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Investigators and outcome assessors will be blinded to participant group allocation. Participants will also be blinded to group assignment up to the point of study initiation.

入排标准

性别
All
接受健康志愿者

入选标准

  • Being a University of Toronto medical student.
  • Being a University of Toronto orthopaedic surgery resident.

排除标准

  • Previous graduation from an orthopaedic surgery residency in Canada or abroad.

结局指标

主要结局

Objective Structured Assessment of Technical Skills (OSATS)

时间窗: 2 weeks after the training sessions, over 30 minutes testing period

The primary outcome of the study is to assess trainee procedural performance using simulators or cadaveric models between the experimental (IVR) and control groups, measured by Objective Structured Assessment of Technical Skill (OSATS) score.

次要结局

  • Experimental and confidence questionnaire(2 weeks after the training sessions, over 30 minutes testing period)
  • Time to complete the procedure(2 weeks after the training sessions, over 30 minutes testing period)
  • Global Ratings Scale (GRS)(2 weeks after the training sessions, over 30 minutes testing period)
  • Hand and body motion analysis using sensors(2 weeks after the training sessions, over 30 minutes testing period)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert Koucheki

Principal Investigator, Lead Researcher

University of Toronto

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