NCT05931679

Brief Summary

The goal is to develop and evaluate two VR simulations (interactive VR, 3600 video) applied to the context of Emergency Medicine. The aim of this pilot study is to develop two VR simulations, and to compare their effectiveness with traditional theatre-based simulations. Primary Objectives: to compare knowledge retention and application of knowledge during emergency crisis scenarios following VR-360, interactive VR and theatre-based simulation sessions. Secondary Objectives: to assess the usability and feasibility (resources), as well as the emotional engagement, of the above three modalities.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

May 11, 2022

Completed
1.1 years until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 5, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 5, 2023

Status Verified

June 1, 2023

Enrollment Period

2.4 years

First QC Date

May 11, 2022

Last Update Submit

June 30, 2023

Conditions

Keywords

Virtual RealitySimulation

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measures will be changes in knowledge and in clinical performance from pre-test to post-test.

    Two experienced trauma resuscitation instructors will view and score the videos independently, blinded to the group allocation and whether the scenario is pre or post the intervention. The raters will evaluate the learners using the Ottawa Global Rating Scale which is a 7 point anchored ordinal scale for performance in five major categories of Crisis Resource Management (CRM) and an overall performance. The score provides 12 items in five category of CRM with a maximum score of 30 points. The higher the number of points, the "better" the individual's performance (better outcome).

    Two weeks, will be done prior to post-test of knowledge and Knowledge application

Secondary Outcomes (4)

  • Mean heart rate (HR)

    During the simulation sessions, throughout the study: 5 minutes prior to start of each scenario, for the duration of each scenario, for the duration of the debriefing, for the duration of the post-test over a 2 week period

  • Peak heart rate (HR)

    During the simulation sessions, throughout the study: 5 minutes prior to start of each scenario, for the duration of each scenario, for the duration of the debriefing, for the duration of the post-test over a 2 week period

  • Heart rate variability - rMSSD

    During the simulation sessions, throughout the study: 5 minutes prior to start of each scenario, for the duration of each scenario, for the duration of the debriefing, for the duration of the post-test

  • Heart rate variability - pNN50

    During the simulation sessions, throughout the study: 5 minutes prior to start of each scenario, for the duration of each scenario, for the duration of the debriefing, for the duration of the post-test over a 2 week period

Study Arms (3)

Interactive VR

ACTIVE COMPARATOR

a virtual classroom - learners wearing VR headsets in the safety of their home are immersed in a computer-generated simulation centre. Through their avatars, they can interact from a first-person perspective with their environment, colleagues and instructors. The virtual patient has been in a car accident and the learners, by interacting with the virtual trauma bay environment, must work together to perform a primary trauma survey and resuscitate the patient. The interactive VR environment provides the team with real time information (e.g. oxygen saturation levels, heart rate) in a realistic environment that includes the uncertainty, noise, and time pressures of a real case.

Device: VR Headset

360 degree video

ACTIVE COMPARATOR

An immersive environment based on high-definition 360o video obtained from our simulation centre. Single learners, wearing a VR headset, find themselves in the resuscitation room, at the foot of the bed, leading a trauma team through the assessment and resuscitation of a patient in a virtual choose-your-own-adventure scenario. At several key points in the videos, learners are presented with interactive decision points, and their choices determine how the rest of the video unfolds.

Device: VR Headset

Theatre-based education

ACTIVE COMPARATOR

Traditional theatre-based simulation sessions require the physical presence of interdisciplinary groups of learners caring for a physical mannequin-based patient, where social distancing is challenging.

Other: Traditional Theatre-based simulation

Interventions

A VR headset will be used for participants in the Interactive VR and 360 degree video groups.

360 degree videoInteractive VR

Traditional theatre-based simulation sessions require the physical presence of interdisciplinary groups of learners caring for a physical mannequin-based patient, where social distancing is challenging.

Theatre-based education

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Participants will be residents or medical students

You may not qualify if:

  • Anyone who is not a resident or medical student

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Glenn Posner

    Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participant will receive a unique study ID which will be used throughout the life of the study
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants will be randomized to one of three groups - interactive VR, 360o video, or theatre-based education.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Division of General Obstetrics and Gynecology

Study Record Dates

First Submitted

May 11, 2022

First Posted

July 5, 2023

Study Start

July 1, 2023

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

July 5, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share