Virtual RealityNCT06442085
Virtual Reality Training for Trauma Resuscitation
A study testing Teaching of trauma resuscitation by using virtual reality simulation and Teaching of trauma resuscitation by using mannequin based simulation in people with Virtual Reality, run by Riga Stradins University at 1 site in Latvia.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality
- What is being tested?
- Teaching of trauma resuscitation by using virtual reality simulation and Teaching of trauma resuscitation by using mannequin based simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteLatvia
- Study dates
- 6 Mar 2020to 14 Dec 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: fluency in English. Exclusion Criteria: history of motion sickness
Trial locations and contacts
1 site in 1 country.
Latvia1 site
Medical Education Technology Centre of Riga Stradins University
Riga
About this study
Official title: Immersive Virtual Reality Versus Mannequin-based Simulation Training for Trauma Resuscitation: a Randomized Controlled Non-inferiority Trial
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.
Read the detailed 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)).
- Conditions
- Virtual Reality
- Being tested
- Teaching of trauma resuscitation by using virtual reality simulation, Teaching of trauma resuscitation by using mannequin based simulation
- Keywords
- Virtual reality, trauma, simulation-based education, resuscitation
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teaching of trauma resuscitation by using virtual reality simulationOther
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 simulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Teaching of trauma resuscitation by using virtual reality simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within a Day
Secondary outcomes (2)
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.
Measured: Within a VR session (less than 10minutes per person)
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).
Measured: Within a Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start6 Mar 2020
- Primary completion30 Sep 2020
- Study completion14 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Virtual RealityStudies 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
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riga Stradins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ainars Stepens, Riga Stradins University
- Investigators
- Ainars Stepens, PhD, MD, Principal investigator, Institute of Public Health, Riga Stradiņš University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442085
- Sponsor's protocol ID
- RigaStradinsU
- Status last verified
- May 2024
- First submitted
- 20 May 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immersive Virtual Reality Versus Mannequin-based Simulation Training for Trauma Resuscitation: a Randomized Controlled Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT06442085
- Acronym / sponsor ID
- RigaStradinsU
- Conditions
- Virtual Reality
- Keywords
- Virtual reality, trauma, simulation-based education, resuscitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Riga Stradins UniversityUniversity, hospital or other
- Study start
- 6 Mar 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 14 Dec 2020 (actual)
- First posted
- 4 Jun 2024 (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.
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
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)).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Medical students - volunteers receiving mannequin based simulation training | Active comparator | Other: Teaching of trauma resuscitation by using mannequin based simulationvolunteers receiving mannequin based simulation training (control), then assessed for primary outcome, analyzed for primary outcome. |
| Medical students - volunteers receiving virtual reality simulation training | Experimental | Other: Teaching of trauma resuscitation by using virtual reality simulationvolunteers receiving virtual reality simulation training (intervention), then assessed for primary outcome, analyzed for primary outcome. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Teaching of trauma resuscitation by using virtual reality simulationThe 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. | Other | Medical students - volunteers receiving virtual reality simulation training |
| Teaching of trauma resuscitation by using mannequin based simulationVolunteers 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. | Other | Medical students - volunteers receiving mannequin based simulation training |
Primary outcome
Trauma Score
Time frame: Within a Day
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.
2 secondary outcomes
Trauma Score in VRS
Time frame: Within a VR session (less than 10minutes per person)
Pre- and Post-Surveys
Time frame: Within a Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- BackgroundBangor A, Kortum P: Determining what individual SUS scores mean: adding an adjective rating scale. Journal of Usability Studies. 2009;4:114-123.
- BackgroundKennedy 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.
- POWER (SAMPLE SIZE) CALCULATORS'Link provided by the sponsor.
- G. C. Urbaniak and S. Plous, 'RESEARCH RANDOMIZER - RANDOM SAMPLING AND RANDOM ASSIGNMENT MADE EASY!Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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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.
Ainars Stepens, PhD, MD principal investigator
Institute of Public Health, Riga Stradiņš University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teaching of trauma resuscitation by using virtual reality simulation and Teaching of trauma resuscitation by using mannequin based simulation in people with Virtual Reality, run by Riga Stradins University at 1 site in Latvia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Latvia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trauma Score (time frame: Within a Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06442085, which also lists 2 linked publications.
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 4 Jun 2024.