Virtual Reality Training for Trauma Resuscitation

Virtual Reality Clinical Trial

Official title:

Immersive Virtual Reality Versus Mannequin-based Simulation Training for Trauma Resuscitation: a Randomized Controlled Non-inferiority Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06442085
• Other study ID #: RigaStradinsU
• Status: Completed
• Phase: N/A
• Start date: March 6, 2020
• Est. completion date: December 14, 2020

Study information

• Verified date: May 2024
• Source: Riga Stradins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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)).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 14, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older
• Eligibility: Inclusion Criteria: fluency in English. Exclusion Criteria: history of motion sickness

Related Conditions & MeSH terms

• Virtual Reality

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Latvia	Medical Education Technology Centre of Riga Stradins University	Riga

Sponsors (1)

Lead Sponsor	Collaborator
Riga Stradins University

Country where clinical trial is conducted

Latvia, 

References & Publications (2)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trauma Score	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.	Within a Day
Secondary	Trauma Score in VRS	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.	Within a VR session (less than 10minutes per person)
Secondary	Pre- and Post-Surveys	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).	Within a Day

External Links

•   G. C. Urbaniak and S. Plous, 'RESEARCH RANDOMIZER - RANDOM SAMPLING AND RANDOM ASSIGNMENT MADE EASY!
•   POWER (SAMPLE SIZE) CALCULATORS'