NCT06445764撤回不适用
Enhancing Trauma Cardiopulmonary Resuscitation Simulation Training With the Use of Virtual Reality (Trauma SimVR): Protocol for a Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Time to critical action
研究概览
简要总结
The goal of this single-center, prospective, randomized, controlled trial is to evaluate the effectiveness of using virtual reality technology to provide learners with skills and knowledge in the management of traumatic cardiac arrest in first-year residents at the emergency department.
The main question it aims to answer is:
Does the use of virtual reality in the context of trauma cardiopulmonary resuscitation training result in shorter times to order/perform pre-defined critical actions?
Participants will learn management skills for in-hospital traumatic cardiac arrest using either newly developed virtual reality software or e-learning focused on the same content.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •first-year residents at the emergency department
- •only people who do not need eyeglasses for using VR
排除标准
- •- pre-disposition for cybersickness (motion sickness, pregnancy, pre-existing cybersickness)
结局指标
主要结局
Time to critical action
时间窗: evaluation within 4 weeks after study completion
Expert-based assessment of the difference in time (seconds) to the predefined primary critical action between randomized groups in video recordings of an in-person assessment simulation.
次要结局
- Time to secondary critical action #1(evaluation within 4 weeks after study completion)
- Time to secondary critical action #2(evaluation within 4 weeks after study completion)
- Number of patients declared dead prematurely(evaluation within 4 weeks after study completion)
- Gender-differences in learning outcomes(evaluation within 4 weeks after study completion)
- Number of unrecognized causes of traumatic cardiac arrest(evaluation within 4 weeks after study completion)
- Number of protocol deviations(evaluation within 4 weeks after study completion)
- Group difference in cognitive load (per objective) while performing the in-person assessment simulation(evaluation within 4 weeks after study completion)
- Gaze behavior during the in-person assessment simulation: fixation count in areas of interest(evaluation within 4 weeks after study completion)
- Participants' overall performance in the simulation sessions from the expert's point of view(evaluation within 4 weeks after study completion)
- The correlation between how often participants have played virtual reality video games between the ages of 6 and 18 and the primary outcome(evaluation within 4 weeks after study completion)
- Group difference in global cognitive load while performing the in-person assessment simulation(evaluation within 4 weeks after study completion)
- Gaze behavior during the in-person assessment simulation: dwell-time in areas of interest(evaluation within 4 weeks after study completion)
- Gaze behavior during the in-person assessment simulation: time when no area of interest is illustrated(evaluation within 4 weeks after study completion)
- Participants' subjective impression of their level of enjoyment when using virtual reality/e-learning(evaluation within 4 weeks after study completion)
- Gaze behavior during the in-person assessment simulation: average fixation duration in areas of interest(evaluation within 4 weeks after study completion)
- Participants' subjective impressions of their learning progress when using virtual reality/e-learning(evaluation within 4 weeks after study completion)
- Participants' subjective impressions of their level of frustration when using virtual reality/e-learning(evaluation within 4 weeks after study completion)
- The correlation between how often participants have played non-virtual-reality video games in the past 12 months and the primary outcome(evaluation within 4 weeks after study completion)
- The correlation between how often participants have played non-virtual-reality video games between the ages of 6 and 18 and the primary outcome(evaluation within 4 weeks after study completion)
- Incidence rate of virtual reality related adverse events(evaluation within 4 weeks after study completion)
- Participants' subjective confidence in recognizing and providing initial care to polytraumatized patients in cardiac arrest in the in-person assessment simulation(evaluation within 4 weeks after study completion)
- Participants' subjective overall performance in the simulation sessions(evaluation within 4 weeks after study completion)
- The correlation between how often participants have played virtual reality video games in the past 12 months and the primary outcome(evaluation within 4 weeks after study completion)
- Adjective Rating Scale for the use of the virtual reality simulations(evaluation within 4 weeks after study completion)
- System usability score for use of VR simulations(evaluation within 4 weeks after study completion)
研究者
Josef Michael Lintschinger
Principal Investigator
Medical University of Vienna
研究点 (2)
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