Traumatic Cardiac Arrest and Trauma SimVR Training

Virtual Reality Clinical Trial

— Trauma SimVR  

Official title:

Enhancing Trauma Cardiopulmonary Resuscitation Simulation Training With the Use of Virtual Reality (Trauma SimVR): Protocol for a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06445764
• Other study ID #: 1388/2023
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2025
• Est. completion date: February 28, 2026

Study information

• Verified date: June 2024
• Source: Medical University of Vienna
• Contact: Josef Michael Lintschinger, MD
• Phone: +4366493228562
• Email: josef.lintschinger[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 67
• Est. completion date: February 28, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

Inclusion Criteria:

• first-year residents at the emergency department

• only people who do not need eyeglasses for using VR

Exclusion Criteria:

• pre-disposition for cybersickness (motion sickness, pregnancy, pre-existing cybersickness)

Related Conditions & MeSH terms

• Heart Arrest
• Virtual Reality

Intervention

Other:
• e-learning
Participants will complete an e-learning course over a two-week period that focuses on skills and knowledge related to the management of in-hospital cardiac arrest. This course prepares participants for an in-person assessment.
• Virtual reality training
Participants will complete a virtual reality training over a two-week period that focuses on skills and knowledge related to the management of in-hospital cardiac arrest. This training prepares participants for an in-person assessment.

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to critical action	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.	evaluation within 4 weeks after study completion
Secondary	Time to secondary critical action #1	Expert-based assessment of the difference in time (seconds) to the predefined secondary critical action #1 between randomized groups in video recordings of an in-person assessment simulation.	evaluation within 4 weeks after study completion
Secondary	Time to secondary critical action #2	Expert-based assessment of the difference in time (seconds) to the predefined secondary critical action #2 between randomized groups in video recordings of an in-person assessment simulation.	evaluation within 4 weeks after study completion
Secondary	Number of unrecognized causes of traumatic cardiac arrest	Expert-based assessment of the difference in unrecognized underlying causes of traumatic cardiac arrest between randomized groups in video recordings of an in-person assessment simulation.	evaluation within 4 weeks after study completion
Secondary	Number of patients declared dead prematurely	Expert-based assessment of the difference in the number of patients declared dead prematurely between the randomized groups in video recordings of an in-person assessment simulation.	evaluation within 4 weeks after study completion
Secondary	Number of protocol deviations	Expert-based assessment of the difference in the frequency of protocol deviations between randomized groups in video recordings of an in-person assessment simulation. Protocol deviations are listed in the study protocol and reflect the recommendations of the guidelines on which the study is based.	evaluation within 4 weeks after study completion
Secondary	Gender-differences in learning outcomes	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 based on gender.	evaluation within 4 weeks after study completion
Secondary	Group difference in global cognitive load while performing the in-person assessment simulation	Assessment of the difference in global cognitive load between randomized groups immediately following the in-person assessment simulation using the National Aeronautics and Space Administration (NASA) global task load index, which ranges from 0 to 100. Higher scores indicate greater cognitive load.	evaluation within 4 weeks after study completion
Secondary	Group difference in cognitive load (per objective) while performing the in-person assessment simulation	Assessment of the difference in cognitive load (per objective) between randomized groups immediately following the in-person assessment simulation using the National Aeronautics and Space Administration (NASA) task load index, which ranges from 0 to 100.; Objectives are: (mental demand, physical demand, temporal demand, performance, effort, frustration). Higher scores indicate greater mental demand/higher physical demand/ higher temporal demand/worse performance/more effort/more frustration).	evaluation within 4 weeks after study completion
Secondary	Gaze behavior during the in-person assessment simulation: dwell-time in areas of interest	Assessment of differences (in seconds) in gaze behavior (dwell time in areas of interest) using Tobii Pro eye-tracking technology between randomized groups based on recordings of the in-person assessment simulation; The defined areas of interest for analysis are the manikin's head/airway, the manikin's thorax, the vital signs monitor, and the ventilator monitor.	evaluation within 4 weeks after study completion
Secondary	Gaze behavior during the in-person assessment simulation: fixation count in areas of interest	Assessment of differences in gaze behavior (fixation count in areas of interest) using Tobii Pro eye-tracking technology between randomized groups based on recordings of the in-person assessment simulation.; The defined areas of interest for analysis are the manikin's head/airway, the manikin's thorax, the vital signs monitor, and the ventilator monitor.	evaluation within 4 weeks after study completion
Secondary	Gaze behavior during the in-person assessment simulation: average fixation duration in areas of interest	Assessment of differences (in seconds) in gaze behavior (average fixation duration in areas of interest) using Tobii Pro eye-tracking technology between randomized groups based on recordings of the in-person assessment simulation; The defined areas of interest for analysis are the manikin's head/airway, the manikin's thorax, the vital signs monitor, and the ventilator monitor.	evaluation within 4 weeks after study completion
Secondary	Gaze behavior during the in-person assessment simulation: time when no area of interest is illustrated	Assessment of differences (in seconds) in gaze behavior (time when no area of interest is illustrated) using Tobii Pro eye-tracking technology between randomized groups based on recordings of the in-person assessment simulation; The defined areas of interst for analysis are the manikin's head/airway, the manikin's thorax, the vital signs monitor, and the ventilator monitor.	evaluation within 4 weeks after study completion
Secondary	Participants' subjective impressions of their learning progress when using virtual reality/e-learning	5-point Likert scale; 1 - not helpful at all; 2 - rather not helpful; 3 - neither helpful nor not helpful; 4 - rather helpful; 5 - very helpful	evaluation within 4 weeks after study completion
Secondary	Participants' subjective impressions of their level of frustration when using virtual reality/e-learning	5-point Likert scale; 1 - not frustrated at all; 2 - rather not frustrated; 3 - neither frustrated nor not frustrated; 4 - rather frustrated; 5 - very frustrated	evaluation within 4 weeks after study completion
Secondary	Participants' subjective impression of their level of enjoyment when using virtual reality/e-learning	5-point Likert scale; 1 - not enjoyed at all; 2 - rather not enjoyed; 3 - neither enjoyed nor not enjoyed; 4 - rather enjoyed; 5 - very enjoyed	evaluation within 4 weeks after study completion
Secondary	Participants' subjective confidence in recognizing and providing initial care to polytraumatized patients in cardiac arrest in the in-person assessment simulation	5-point Likert scale; 1 - not confident at all; 2 - rather not confident; 3 - neither confident nor not confident; 4 - rather confident; 5 - very confident	evaluation within 4 weeks after study completion
Secondary	Participants' subjective overall performance in the simulation sessions	5-point Likert scale; 1 - not good at all; 2 - rather not good; 3 - neither good nor not good; 4 - rather good; 5 - very good	evaluation within 4 weeks after study completion
Secondary	Participants' overall performance in the simulation sessions from the expert's point of view	5-point Likert scale; 1 - not good at all; 2 - rather not good; 3 - neither good nor not good; 4 - rather good; 5 - very good	evaluation within 4 weeks after study completion
Secondary	The correlation between how often participants have played virtual reality video games in the past 12 months and the primary outcome	Spearman correlation; Frequency of playing within the past 12 months: never; less than once a week; once per week; more than once per week; daily	evaluation within 4 weeks after study completion
Secondary	The correlation between how often participants have played virtual reality video games between the ages of 6 and 18 and the primary outcome	Spearman correlation; Frequency of playing at the age of 6 to 18: never; less than once a week; once per week; more than once per week; daily	evaluation within 4 weeks after study completion
Secondary	The correlation between how often participants have played non-virtual-reality video games in the past 12 months and the primary outcome	Spearman correlation; Frequency of playing within the past 12 months: never; less than once a week; once per week; more than once per week; daily	evaluation within 4 weeks after study completion
Secondary	The correlation between how often participants have played non-virtual-reality video games between the ages of 6 and 18 and the primary outcome	Spearman correlation; Frequency of playing at the age of 6 to 18: never; less than once a week; once per week; more than once per week; daily	evaluation within 4 weeks after study completion
Secondary	Incidence rate of virtual reality related adverse events	Incidence of nausea, vomiting, dizziness, headache, overexertion/fatigue of the eyes (discomfort, blurred vision), stumbling, falling, bumping into real world objects while using virtual reality	evaluation within 4 weeks after study completion
Secondary	System usability score for use of VR simulations	System Usability Scale score from 1 to 100 points	evaluation within 4 weeks after study completion
Secondary	Adjective Rating Scale for the use of the virtual reality simulations	7-point Likert scale; 1 - the worst thing you can imagine; 2 - terrible; 3 - poor; 4 - okay; 5 - good; 6 - excellent; 7 - the best thing you can imagine	evaluation within 4 weeks after study completion