Virtual Reality Training for Trauma Resuscitation

NCT ID: NCT06442085

Last Updated: 2024-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-06

Study Completion Date

2020-12-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study individual training with an immersive virtual reality Trauma Simulator was compared to live mannequin-based simulation training in a facilitated group. The results showed that virtual reality simulator led to non-inferior effects on trauma resuscitation skills to mannequin-based simulation. Trauma Simulator had good usability, was well received by the participants, and had minimal adverse effects.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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)).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Virtual Reality

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This was a prospective, single-center, randomized, controlled, non-inferiority, simulation-based trial comparing the use of virtual reality simulation vs. mannequin based simulation in a simulated trauma scenario.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
All assessments of the student performances were recorded either by video camera (mannequin based simulation) or screen capture (virtual reality simulation). All videos were assessed by two blinded raters independently. In order to maintain consistency, virtual reality recordings were also scored manually by the raters, instead of the automated Trauma Simulator built-in tool. The video data were stored for the reviews and deleted afterwards.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Medical students - volunteers receiving mannequin based simulation training

volunteers receiving mannequin based simulation training (control), then assessed for primary outcome, analyzed for primary outcome.

Group Type ACTIVE_COMPARATOR

Teaching of trauma resuscitation by using mannequin based simulation

Intervention Type OTHER

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.

Medical students - volunteers receiving virtual reality simulation training

volunteers receiving virtual reality simulation training (intervention), then assessed for primary outcome, analyzed for primary outcome.

Group Type EXPERIMENTAL

Teaching of trauma resuscitation by using virtual reality simulation

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Teaching of trauma resuscitation by using virtual reality simulation

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.

Intervention Type OTHER

Teaching of trauma resuscitation by using mannequin based simulation

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Inclusion Criteria: fluency in English.

Exclusion Criteria

Exclusion Criteria: history of motion sickness
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Riga Stradins University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ainars Stepens

Lead researcher in Institute of Public Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ainars Stepens, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Public Health, Riga Stradiņš University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical Education Technology Centre of Riga Stradins University

Riga, , Latvia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Latvia

References

Explore related publications, articles, or registry entries linked to this study.

Bangor A, Kortum P: Determining what individual SUS scores mean: adding an adjective rating scale. Journal of Usability Studies. 2009;4:114-123.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

Related Links

Access external resources that provide additional context or updates about the study.

https://www.randomizer.org

G. C. Urbaniak and S. Plous, 'RESEARCH RANDOMIZER - RANDOM SAMPLING AND RANDOM ASSIGNMENT MADE EASY!

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RigaStradinsU

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Virtual Reality Use for ICU Mobility
NCT07234201 RECRUITING NA