NCT06442085

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 6, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2020

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 4, 2024

Completed
Last Updated

June 4, 2024

Status Verified

May 1, 2024

Enrollment Period

7 months

First QC Date

May 20, 2024

Last Update Submit

May 29, 2024

Conditions

Keywords

Virtual realitytraumasimulation-based educationresuscitation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Trauma Score in VRS

    Within a VR session (less than 10minutes per person)

  • Pre- and Post-Surveys

    Within a Day

Study Arms (2)

Medical students - volunteers receiving mannequin based simulation training

ACTIVE COMPARATOR

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

Other: Teaching of trauma resuscitation by using mannequin based simulation

Medical students - volunteers receiving virtual reality simulation training

EXPERIMENTAL

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

Other: Teaching of trauma resuscitation by using virtual reality simulation

Interventions

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.

Medical students - volunteers receiving virtual reality simulation training

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 mannequin based simulation training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Education Technology Centre of Riga Stradins University

Riga, Latvia

Location

Related 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.

    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.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Ainars Stepens, PhD, MD

    Institute of Public Health, Riga Stradiņš University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lead researcher in Institute of Public Health

Study Record Dates

First Submitted

May 20, 2024

First Posted

June 4, 2024

Study Start

March 6, 2020

Primary Completion

September 30, 2020

Study Completion

December 14, 2020

Last Updated

June 4, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Participants were volunteers. Their data has been protected by General data protection regulation (GDPR). The anonymized Trauma Score of each participant group is available upon request.

Locations