- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06445764
Traumatic Cardiac Arrest and Trauma SimVR Training (Trauma SimVR)
Enhancing Trauma Cardiopulmonary Resuscitation Simulation Training With the Use of Virtual Reality (Trauma SimVR): Protocol for a Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Vienna, Austria, 1090
- Medical University of Vienna
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
|
Other: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to critical action
Time Frame: 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.
|
evaluation within 4 weeks after study completion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to secondary critical action #1
Time Frame: evaluation within 4 weeks after study completion
|
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
|
|
Time to secondary critical action #2
Time Frame: evaluation within 4 weeks after study completion
|
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
|
|
Number of unrecognized causes of traumatic cardiac arrest
Time Frame: evaluation within 4 weeks after study completion
|
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
|
|
Number of patients declared dead prematurely
Time Frame: evaluation within 4 weeks after study completion
|
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
|
|
Number of protocol deviations
Time Frame: evaluation within 4 weeks after study completion
|
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
|
|
Gender-differences in learning outcomes
Time Frame: 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 based on gender.
|
evaluation within 4 weeks after study completion
|
|
Group difference in global cognitive load while performing the in-person assessment simulation
Time Frame: evaluation within 4 weeks after study completion
|
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
|
|
Group difference in cognitive load (per objective) while performing the in-person assessment simulation
Time Frame: evaluation within 4 weeks after study completion
|
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
|
|
Gaze behavior during the in-person assessment simulation: dwell-time in areas of interest
Time Frame: evaluation within 4 weeks after study completion
|
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
|
|
Gaze behavior during the in-person assessment simulation: fixation count in areas of interest
Time Frame: evaluation within 4 weeks after study completion
|
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
|
|
Gaze behavior during the in-person assessment simulation: average fixation duration in areas of interest
Time Frame: evaluation within 4 weeks after study completion
|
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
|
|
Gaze behavior during the in-person assessment simulation: time when no area of interest is illustrated
Time Frame: evaluation within 4 weeks after study completion
|
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
|
|
Participants' subjective impressions of their learning progress when using virtual reality/e-learning
Time Frame: evaluation within 4 weeks after study completion
|
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
|
|
Participants' subjective impressions of their level of frustration when using virtual reality/e-learning
Time Frame: evaluation within 4 weeks after study completion
|
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
|
|
Participants' subjective impression of their level of enjoyment when using virtual reality/e-learning
Time Frame: evaluation within 4 weeks after study completion
|
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
|
|
Participants' subjective confidence in recognizing and providing initial care to polytraumatized patients in cardiac arrest in the in-person assessment simulation
Time Frame: evaluation within 4 weeks after study completion
|
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
|
|
Participants' subjective overall performance in the simulation sessions
Time Frame: evaluation within 4 weeks after study completion
|
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
|
|
Participants' overall performance in the simulation sessions from the expert's point of view
Time Frame: evaluation within 4 weeks after study completion
|
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
|
|
The correlation between how often participants have played virtual reality video games in the past 12 months and the primary outcome
Time Frame: evaluation within 4 weeks after study completion
|
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
|
|
The correlation between how often participants have played virtual reality video games between the ages of 6 and 18 and the primary outcome
Time Frame: evaluation within 4 weeks after study completion
|
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
|
|
The correlation between how often participants have played non-virtual-reality video games in the past 12 months and the primary outcome
Time Frame: evaluation within 4 weeks after study completion
|
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
|
|
The correlation between how often participants have played non-virtual-reality video games between the ages of 6 and 18 and the primary outcome
Time Frame: evaluation within 4 weeks after study completion
|
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
|
|
Incidence rate of virtual reality related adverse events
Time Frame: evaluation within 4 weeks after study completion
|
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
|
|
System usability score for use of VR simulations
Time Frame: evaluation within 4 weeks after study completion
|
System Usability Scale score from 1 to 100 points
|
evaluation within 4 weeks after study completion
|
|
Adjective Rating Scale for the use of the virtual reality simulations
Time Frame: evaluation within 4 weeks after study completion
|
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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1388/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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