Work-Related ConditionNCT03863314
Virtual Reality vs Inperson Simulation: A Non-inferiority Study
A study testing Virtual Simulation and In-person Simulation in people with Work-Related Condition, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to determine if Virtual Reality (VR) can elicit emotional responses that are captured via physiological biometrics such as heart rate variability and skin conductance levels. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Work-Related Condition
- What is being tested?
- Virtual Simulation and In-person Simulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2019to 15 Nov 2019
- 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
Who may be able to join
- Greater than 18 years of age
- Personnel working or volunteering at Lucile Packard Children's Hospital (LPCH) or Stanford Health Care (SHC) facilities
Who cannot join
- Patients who do not consent
- Are currently taking beta blockers or other chronotropic heart medication(s)
- Have a history of severe motion sickness
- Currently have nausea
- Currently experiencing seizures
- Are clinically unstable
Trial locations and contacts
1 site in 1 country.
United States1 site
Lucile Packard Children's Hospital Stanford
Palo Alto, California, 94304
About this study
The purpose of this study is to determine if Virtual Reality (VR) can elicit emotional responses that are captured via physiological biometrics such as heart rate variability and skin conductance levels. As a non-inferiority study the investigators anticipate the technologies will elicit an emotional not inferior to those responses of an in-person simulations of workplace scenarios (i.e medical error and workplace harassment).
- Conditions
- Work-Related Condition
- Being tested
- Virtual Simulation, In-person Simulation
- Keywords
- Virtual Reality, Simulation, Workplace
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual SimulationDevice
Virtual simulation of workplace-related scenarios of pre-recorded videos using the same actors
In-person SimulationOther
In-person simulation of workplace-related scenarios with live actors
| Study group | Role | What they receive |
|---|---|---|
| In-Person Simulation | Active comparator | Participants will experience in-person simulations of different workplace scenarios such as medical error and workplace harassment Receives: Other: In-person Simulation |
| Virtual Simulation | Experimental | Participants will experience virtual simulations of different workplace scenarios such as medical error and workplace harassment via Virtual Reality headset. Receives: Device: Virtual Simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory sinus arrhythmia
Biometric sensors will be placed in strategic locations in order to collect respiratory sinus arrhythmia throughout either in-person or virtual simulation
Measured: Throughout duration of simulation, approximately 15 minutes
Secondary outcomes (3)
Skin conductance levels
Skin conductance levels as measured by electrodermal activity will be collected using biometric sensors throughout either in-person or virtual simulation
Measured: Throughout duration of simulation, approximately 15 minutes
Emotional levels
Emotional affect will be self reported via validated scale before and after the intervention.
Measured: Throughout duration of intervention, two minutes before and after the intervention
VR Simulation Questionnaire
Participants will be given a questionnaire regarding their virtual or in-person simulation experience and the overall similarity to real-life on a scale from 1-5 (1=Completely Different and 5=Nearly Identical) Example Questions: "How true to real life were the emotions expressed during the scenario?" and "How true to real life was the the clinical environment?"
Measured: Three months post study, approximately 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start9 Jul 2019
- Primary completion11 Jul 2019
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Work-Related ConditionStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Caruso, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863314
- Sponsor's protocol ID
- 48883
- Status last verified
- Apr 2020
- First submitted
- 28 Feb 2019
- Last updated
- 13 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bernardo A. Virtual Reality and Simulation in Neurosurgical Training. World Neurosurg. 2017 Oct;106:1015-1029. doi: 10.1016/j.wneu.2017.06.140.
PubMed 28985656Kyaw BM, Saxena N, Posadzki P, Vseteckova J, Nikolaou CK, George PP, Divakar U, Masiello I, Kononowicz AA, Zary N, Tudor Car L. Virtual Reality for Health Professions Education: Systematic Review and Meta-Analysis by the Digital Health Education Collaboration. J Med Internet Res. 2019 Jan 22;21(1):e12959. doi: 10.2196/12959.
PubMed 30668519Fan YC, Wen CY. A Virtual Reality Soldier Simulator with Body Area Networks for Team Training. Sensors (Basel). 2019 Jan 22;19(3):451. doi: 10.3390/s19030451.
PubMed 30678276
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality vs Inperson Simulation: A Non-inferiority Study
- ClinicalTrials.gov ID
- NCT03863314
- Acronym / sponsor ID
- 48883
- Conditions
- Work-Related Condition
- Keywords
- Virtual Reality, Simulation, Workplace
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 9 Jul 2019 (actual)
- Primary completion
- 11 Jul 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 5 Mar 2019 (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 purpose of this study is to determine if Virtual Reality (VR) can elicit emotional responses that are captured via physiological biometrics such as heart rate variability and skin conductance levels. As a non-inferiority study the investigators anticipate the technologies will elicit an emotional not inferior to those responses of an in-person simulations of workplace scenarios (i.e medical error and workplace harassment).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-Person Simulation | Active comparator | Other: In-person SimulationParticipants will experience in-person simulations of different workplace scenarios such as medical error and workplace harassment |
| Virtual Simulation | Experimental | Device: Virtual SimulationParticipants will experience virtual simulations of different workplace scenarios such as medical error and workplace harassment via Virtual Reality headset. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Greater than 18 years of age
- Personnel working or volunteering at Lucile Packard Children's Hospital (LPCH) or Stanford Health Care (SHC) facilities
Key exclusion criteria (6 listed)
- Patients who do not consent
- Are currently taking beta blockers or other chronotropic heart medication(s)
- Have a history of severe motion sickness
- Currently have nausea
- Currently experiencing seizures
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 |
|---|---|---|
| Virtual SimulationVirtual simulation of workplace-related scenarios of pre-recorded videos using the same actors | Device | Virtual Simulation |
| In-person SimulationIn-person simulation of workplace-related scenarios with live actors | Other | In-Person Simulation |
Primary outcome
Respiratory sinus arrhythmia
Time frame: Throughout duration of simulation, approximately 15 minutes
Biometric sensors will be placed in strategic locations in order to collect respiratory sinus arrhythmia throughout either in-person or virtual simulation
3 secondary outcomes
Skin conductance levels
Time frame: Throughout duration of simulation, approximately 15 minutes
Emotional levels
Time frame: Throughout duration of intervention, two minutes before and after the intervention
VR Simulation Questionnaire
Time frame: Three months post study, approximately 5 minutes
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 13 Apr 2020.
- Background: PubMed 28985656Bernardo A. Virtual Reality and Simulation in Neurosurgical Training. World Neurosurg. 2017 Oct;106:1015-1029. doi: 10.1016/j.wneu.2017.06.140.
- Background: PubMed 30668519Kyaw BM, Saxena N, Posadzki P, Vseteckova J, Nikolaou CK, George PP, Divakar U, Masiello I, Kononowicz AA, Zary N, Tudor Car L. Virtual Reality for Health Professions Education: Systematic Review and Meta-Analysis by the Digital Health Education Collaboration. J Med Internet Res. 2019 Jan 22;21(1):e12959. doi: 10.2196/12959.
- Background: PubMed 30678276Fan YC, Wen CY. A Virtual Reality Soldier Simulator with Body Area Networks for Team Training. Sensors (Basel). 2019 Jan 22;19(3):451. doi: 10.3390/s19030451.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Simulation and In-person Simulation in people with Work-Related Condition, run by Stanford University at 1 site in United States.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 13 Apr 2020. 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 United States. 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?
Respiratory sinus arrhythmia (time frame: Throughout duration of simulation, approximately 15 minutes). 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 NCT03863314, which also lists 3 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 13 Apr 2020.