COVID 19NCT05931679
Pandemic-Proofing Simulation-based Education
A study testing VR Headset and Traditional Theatre-based simulation in people with COVID 19, run by Ottawa Hospital Research Institute.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- COVID 19
- What is being tested?
- VR Headset and Traditional Theatre-based simulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Jul 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Participants will be residents or medical students
Who cannot join
- Anyone who is not a resident or medical student
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pandemic-Proofing Simulation-based Education: Development and Evaluation of Interactive Virtual Educational Content for Medical Trainees
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.
Read the detailed description
Phase 1: Creation of Content: A software engineer with expertise in video-game development will be hired to develop the computer-generated emergency department in collaboration with the educators and clinicians on the team. A theatre-based trauma scenario from the current uOttawa Emergency Department curriculum will be adapted to the VR platform. This virtual environment will allow a team of students to manage a patient simultaneously through their avatars, from a first-person perspective. In parallel, the same scenario will be scripted, in all its permutations, and recorded using a 360-degree HD video camera. The recording will be made using the investigators as actors, with additional interprofessional volunteers recruited as needed. These videos will be edited and then converted to an application that can be uploaded to the Oculus platform. Both platforms will undergo piloting for content and usability. The amount of time, money and other resources required to develop each of these scenarios will be calculated.
Phase 2: Evaluating the intervention:
Pre-test: Prior to participating in one of the 3 educational interventions, participants will complete a pre-test of their content-specific knowledge and knowledge application with respect to trauma resuscitation. As well, they will participate in a video-recorded in-situ simulation of a trauma resuscitation. Team performance will be recorded for subsequent scoring (see measures and analysis section below). During the in-situ sessions, the investigators will measure the learners' heart rate (HR) and heart rate variability (HRV) with the use of a Polar H10 chest belt linked with a commercial capture and analysis software program on an iPad. This will allow us to measure both arousal and stress responses, as physiological indication of the learners' emotional engagement.
Intervention: Following the pre-test, residents will either participate in the interactive VR, the 360o video or the in-person theatre-based simulation sessions.
Post-test. Two weeks after the education session, all participants will complete a post-test of their knowledge and knowledge application (matched in difficulty with pre-test), as well as lead an in-situ simulated trauma resuscitation. The sessions will be videotaped for subsequent rating of clinical and team performance.
- Conditions
- COVID 19
- Being tested
- VR Headset, Traditional Theatre-based simulation
- Keywords
- Virtual Reality, Simulation
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR HeadsetDevice
A VR headset will be used for participants in the Interactive VR and 360 degree video groups.
Traditional Theatre-based simulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Traditional Theatre-based simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Two weeks, will be done prior to post-test of knowledge and Knowledge application
Secondary outcomes (4)
Mean heart rate (HR)
The investigators will compare arousal levels between the 3 experimental conditions (interactive VR, 360o video, theatre-based) by heart rate monitoring. Continuous heart rate (R-R intervals) will be measured with the POLAR® H10 device, a non-invasive chest strap with a transducer worn directly against the sternum paired with a smart device application (EliteHRV). The participants heart rate will be recorded for 5 minutes prior to start of each scenario (Pre-scenario - to capture anticipatory stress responses), for the duration of the debriefing (divided into sequential 5 min periods), for the duration of the post-test (divided into sequential 5 min periods]. For each participant, the investigators will analyse the participant's mean heart rate (averaged over each measured time period)..
Measured: 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)
The investigators will compare arousal levels between the 3 experimental conditions (interactive VR, 360o video, theatre-based) by heart rate monitoring. Continuous heart rate (R-R intervals) will be measured with the POLAR® H10 device, a non-invasive chest strap with a transducer worn directly against the sternum paired with a smart device application (EliteHRV). The participants heart rate will be recorded for 5 minutes prior to start of each scenario (Pre-scenario - to capture anticipatory stress responses), for the duration of the debriefing, for the duration of the post-test. For each participant, the investigators will analyse the participant's peak heart rate over each time period.
Measured: 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
The investigators will compare individual stress scores between the 3 experimental conditions (interactive VR, 360o video, theatre-based) by heart rate variability (HRV) monitoring. Continuous heart rate (R-R intervals) will be measured with the POLAR® H10 device, a non-invasive chest strap with a transducer worn directly against the sternum paired with a smart device application (EliteHRV). The participants HRV will be recorded for 5 minutes prior to start of each scenario (Pre-scenario - to capture anticipatory stress responses), for the duration of the debriefing (divided into sequential 5 min periods), for the duration of the post-test (divided into sequential 5 min periods]. For each participant, the investigators will analyse the participant's root mean square of successive R-R interval differences (rMSSD).
Measured: 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
The investigators will compare individual stress scores between the 3 experimental conditions (interactive VR, 360o video, theatre-based) by heart rate variability (HRV) monitoring. Continuous heart rate (R-R intervals) will be measured with the POLAR® H10 device, a non-invasive chest strap with a transducer worn directly against the sternum paired with a smart device application (EliteHRV). The participants HRV will be recorded for 5 minutes prior to start of each scenario (Pre-scenario - to capture anticipatory stress responses), for the duration of the debriefing (divided into sequential 5 min periods), for the duration of the post-test (divided into sequential 5 min periods]. For each participant, the investigators will analyse the participant's percentage of successive R-R intervals that differ by more than 50Ms (pNN50).
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study startJul 2023 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID 19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to one of three groups - interactive VR, 360o video, or theatre-based education.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Research Institute
- Responsible party
- Principal investigator, Glenn Posner, Ottawa Hospital Research Institute
- Investigators
- Glenn Posner, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931679
- Sponsor's protocol ID
- 20210197-01H
- Status last verified
- Jun 2023
- First submitted
- 11 May 2022
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pandemic-Proofing Simulation-based Education: Development and Evaluation of Interactive Virtual Educational Content for Medical Trainees
- ClinicalTrials.gov ID
- NCT05931679
- Acronym / sponsor ID
- 20210197-01H
- Conditions
- COVID 19
- Keywords
- Virtual Reality, Simulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Sunnybrook Research Institute
- Study start
- Jul 2023 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 5 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Phase 1: Creation of Content: A software engineer with expertise in video-game development will be hired to develop the computer-generated emergency department in collaboration with the educators and clinicians on the team. A theatre-based trauma scenario from the current uOttawa Emergency Department curriculum will be adapted to the VR platform. This virtual environment will allow a team of students to manage a patient simultaneously through their avatars, from a first-person perspective. In parallel, the same scenario will be scripted, in all its permutations, and recorded using a 360-degree HD video camera. The recording will be made using the investigators as actors, with additional interprofessional volunteers recruited as needed. These videos will be edited and then converted to an application that can be uploaded to the Oculus platform. Both platforms will undergo piloting for content and usability. The amount of time, money and other resources required to develop each of these scenarios will be calculated.
Phase 2: Evaluating the intervention:
Pre-test: Prior to participating in one of the 3 educational interventions, participants will complete a pre-test of their content-specific knowledge and knowledge application with respect to trauma resuscitation. As well, they will participate in a video-recorded in-situ simulation of a trauma resuscitation. Team performance will be recorded for subsequent scoring (see measures and analysis section below). During the in-situ sessions, the investigators will measure the learners' heart rate (HR) and heart rate variability (HRV) with the use of a Polar H10 chest belt linked with a commercial capture and analysis software program on an iPad. This will allow us to measure both arousal and stress responses, as physiological indication of the learners' emotional engagement.
Intervention: Following the pre-test, residents will either participate in the interactive VR, the 360o video or the in-person theatre-based simulation sessions.
Post-test. Two weeks after the education session, all participants will complete a post-test of their knowledge and knowledge application (matched in difficulty with pre-test), as well as lead an in-situ simulated trauma resuscitation. The sessions will be videotaped for subsequent rating of clinical and team performance.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Participants will be randomized to one of three groups - interactive VR, 360o video, or theatre-based education.
| Arm | Type | Receives |
|---|---|---|
| Interactive VR | Active comparator | Device: VR Headseta 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. |
| 360 degree video | Active comparator | Device: VR HeadsetAn 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. |
| Theatre-based education | Active comparator | Other: Traditional Theatre-based simulationTraditional 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Participants will be residents or medical students
Key exclusion criteria (1 listed)
- Anyone who is not a resident or medical student
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR HeadsetA VR headset will be used for participants in the Interactive VR and 360 degree video groups. | Device | 360 degree video, Interactive VR |
| Traditional Theatre-based simulationTraditional 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 | Theatre-based education |
Primary outcome
The primary outcome measures will be changes in knowledge and in clinical performance from pre-test to post-test.
Time frame: Two weeks, will be done prior to post-test of knowledge and Knowledge application
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).
4 secondary outcomes
Mean heart rate (HR)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for COVID 19
RecruitingPhase 3
A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease
SARS-CoV-2
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Active, not recruiting
Motivational Interviewing Intervention for Families With Overweight and Obesity
Obesity & Overweight
Active, not recruiting
Lupus Education Alliance Program
Systemic Lupus Erythematosus, COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glenn Posner principal investigator
Ottawa Hospital Research Institute
Questions about this trial
What is this clinical trial studying?
A study testing VR Headset and Traditional Theatre-based simulation in people with COVID 19, run by Ottawa Hospital Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Glenn Posner (613-737-8899, gposner@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measures will be changes in knowledge and in clinical performance from pre-test to post-test. (time frame: Two weeks, will be done prior to post-test of knowledge and Knowledge application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.