- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06442085
Virtual Reality Training for Trauma Resuscitation
Immersive Virtual Reality Versus Mannequin-based Simulation Training for Trauma Resuscitation: a Randomized Controlled Non-inferiority Trial
Study Overview
Status
Conditions
Detailed Description
Background: Despite its high potential, the effect of immersive virtual reality simulation (VRS) in trauma resuscitation training has not been studied. The aim of this study was to test the hypothesis that VRS is non-inferior to mannequin-based simulation (MBS) in trauma resuscitation training.
Methods: In a single-center, randomized controlled non-inferiority trial, we compared individual training with an immersive virtual reality Trauma Simulator to live MBS training in a facilitated group. The primary outcome was the Trauma Score (ranging from 55 (worse) to 177 (best outcome)) during the MBS assessment. The secondary outcomes were the Trauma Score VRS assessment, System Usability Scale (ranging from 0 (worse) -100 (best outcome)), and Simulation Sickness Questionnaire (ranging from 0 (worse) to 235.62 (best outcome)).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Riga, Latvia
- Medical Education Technology Centre of Riga Stradins University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Medical students - volunteers receiving mannequin based simulation training
volunteers receiving mannequin based simulation training (control), then assessed for primary outcome, analyzed for primary outcome.
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Volunteers were trained in groups of three or four by using mannequin-based rapid cycle deliberate practice simulation facilitated by a critical care physician.
Next, the volunteers had 50 min training of the same trauma scenario as the intervention group.
The simulation facility was set-up as close as possible to the virtual reality environment.
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Experimental: Medical students - volunteers receiving virtual reality simulation training
volunteers receiving virtual reality simulation training (intervention), then assessed for primary outcome, analyzed for primary outcome.
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The intervention was teaching of trauma resuscitation by using VRS.
Following welcome and a video lecture by Advance Trauma Life Support certified physician, the intervention group participants were orientated (15 minutes) to the VRS environment, head-mounted display (Oculus Rift S or Oculus Quest, Oculus, USA) and hand controllers by playing game First Steps (Oculus, USA).
Then the participants were training by using the "Internal Hemorrhage" scenario in Trauma Simulator.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Trauma Score
Time Frame: Within a Day
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The primary outcome of the study is Trauma Score (range 55 (worst) to 177(best outcome) during an individual assessment in a mannequin-based simulation environment.
The assessment was based on the video recordings analyzing students during performing in the scenario.
The Trauma Score is an assessment tool developed by military emergency medicine experts for the Trauma Simulator.
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Within a Day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Trauma Score in VRS
Time Frame: Within a VR session (less than 10minutes per person)
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Trauma Score in the VRS environment served as a secondary outcome.
System Usability Scale: a 10-item questionnaire (range 0-100, where 0 is the worst, 100 the best performance) was used to assess usability of Trauma Simulator.
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Within a VR session (less than 10minutes per person)
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Pre- and Post-Surveys
Time Frame: Within a Day
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The students will receive pre and post surveys.
The surveys are structured to evaluate students' experience before and after the training.
As a reference, the evaluation tools are made, based on Bangor et al., 2009.
A custom, six-question survey (5-point Likert scale) was used to assess the perception of Virtual Reality simulation before and after the study.
Presence of cybersickness was evaluated by using Simulation Sickness Questionnaire (SSQ).15
SSQ assesses 16 symptoms of motion sickness in three domains: nausea (7 symptoms), disorientation (7 symptoms), and oculomotor effects (7 symptoms).
Each symptom is self-reported as none (0), slight (1), moderate (2), and severe (3).
Total Severity score is calculated as the sum of individual symptom scores in each domain multiplied by 3.74 in accordance with Kennedy et al. (1993), thus the final score ranges from 0 (worst) to 235.62 (best outcome).
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Within a Day
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ainars Stepens, PhD, MD, Institute of Public Health, Riga Stradiņš University
Publications and helpful links
General Publications
- Bangor A, Kortum P: Determining what individual SUS scores mean: adding an adjective rating scale. Journal of Usability Studies. 2009;4:114-123.
- Kennedy RS, Lane NE, Berbaum KS, Lilienthal MG: Simulator Sickness Questionnaire: an enhanced method for quantifying simulator sickness. The International Journal of Aviation Psychology. 1993;3:203-220.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RigaStradinsU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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