Augmented RealityNCT05674188
AR vs In Person Simulation for Medical Workplace Training
A study testing Augmented Reality Headset in people with Augmented Reality, run by Stanford University at 1 site in United States.
Trial summary
This study will evaluate the physiologic and emotional effects of an augmented reality (AR) simulation versus an in-person simulation. This is a single institution, non-inferiority, randomized controlled trial. The target enrollment will be 100 participants in each group for a total of 200 participants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Augmented Reality
- What is being tested?
- Augmented Reality Headset
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2023to 22 Mar 2023
- 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
- Hospital providers, including nurses, physician assistants, physicians, physician trainees, and other healthcare workers at Lucile Packard Children's Hospital (LPCH) and affiliated facilities who communicate with patients daily will be included
Who cannot join
- Participants with reported severe motion sickness
- Nausea
- Seizure disorder
- Currently using chronotropic heart medications, such as β blockers
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
Official title: The Physiologic and Emotional Effects of Augmented Reality Simulation Versus In Person Simulation - A Noninferiority, Randomized Controlled Trial
This study will evaluate the physiologic and emotional effects of an augmented reality (AR) simulation versus an in-person simulation. This is a single institution, non-inferiority, randomized controlled trial. The target enrollment will be 100 participants in each group for a total of 200 participants. One group will wear an AR headset and participate in an AR medical crisis scenario and the other group will participate in the same scenario with a traditional, mannequin based in situ simulation.
- Conditions
- Augmented Reality
- Being tested
- Augmented Reality Headset
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented Reality HeadsetBehavioural
Augmented simulation of workplace-related scenarios of pre-recorded videos using the same actors
| Study group | Role | What they receive |
|---|---|---|
| Augmented Reality Enhanced Simulation (Treatment group) | Experimental | Participants will experience augmented simulations with a holographic mixed-reality setting based on different workplace scenarios such as medical error and workplace harassment via Augmented Reality (AR) headset. Receives: Behavioral: Augmented Reality Headset |
| Traditional In Situ Simulation (Control group) | No intervention | Participants will experience in-person simulations of different workplace scenarios such as medical error and workplace harassment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parasympathetic response indexed by RSA
Measured via respiratory sinus arrhythmia (RSA) in hertz using chest biometric sensors in 30-second epochs.
Measured: Duration of simulation (15-20 minutes)
Secondary outcomes (4)
Sytem Usability Scale (SUS)
10-item questionnaire with a scale from 1- 5, 1 being strongly disagree to 5 being strongly agree on a five-point Likert scale to measure usability. Only administered to the AR group.
Measured: Post-simulation (5 minutes)
ISO 9241-400
6-item ergonomic questionnaire with a scale from 1- 5, 1 being strongly disagree to 5 being strongly agree on a five-point Likert scale only administered to the AR group.
Measured: Post-simulation (5 minutes)
Simulation Design Scale (SDS)
20-item questionnaire with a scale from 1- 5, 1 being strongly disagree to 5 being strongly agree on a five-point Likert scale to assess user satisfaction
Measured: Post-simulation (5-10 minutes)
Learning effectiveness
Five months post-simulation, an assessment was sent out to participants with a 10-item, multiple choice with questions related to key learning points about resuscitation management.
Measured: 5 months-post simulation (5 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start20 Mar 2023
- Primary completion22 Mar 2023
- Study completion22 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Augmented RealityStudies 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
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Caruso, Stanford University
- Investigators
- Thomas J Caruso, MD, MEd, Principal investigator, clinical professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674188
- Sponsor's protocol ID
- 68663
- Status last verified
- Dec 2023
- First submitted
- 21 Dec 2022
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rama A, Rojas-Pino MS, Wang EY, Rodriguez ST, Suen MY, Titzler JS, Zuniga-Hernandez M, Jackson C, Rosales O, Collins F, Caruso TJ. The Physiologic Effect of Augmented Reality Simulation Versus Traditional Simulation: A Noninferiority, Randomized Controlled Trial. J Educ Perioper Med. 2025 Apr 8;27(1):E740. doi: 10.46374/VolXXVII_Issue1_Rama. eCollection 2025 Jan-Mar.
PubMed 40207076
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Physiologic and Emotional Effects of Augmented Reality Simulation Versus In Person Simulation - A Noninferiority, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05674188
- Acronym / sponsor ID
- 68663
- Conditions
- Augmented Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 22 Mar 2023 (actual)
- Study completion
- 22 Mar 2023 (actual)
- First posted
- 6 Jan 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.
This study will evaluate the physiologic and emotional effects of an augmented reality (AR) simulation versus an in-person simulation. This is a single institution, non-inferiority, randomized controlled trial. The target enrollment will be 100 participants in each group for a total of 200 participants. One group will wear an AR headset and participate in an AR medical crisis scenario and the other group will participate in the same scenario with a traditional, mannequin based in situ simulation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Augmented Reality Enhanced Simulation (Treatment group) | Experimental | Behavioral: Augmented Reality HeadsetParticipants will experience augmented simulations with a holographic mixed-reality setting based on different workplace scenarios such as medical error and workplace harassment via Augmented Reality (AR) headset. |
| Traditional In Situ Simulation (Control group) | No intervention | –Participants will experience in-person simulations of different workplace scenarios such as medical error and workplace harassment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hospital providers, including nurses, physician assistants, physicians, physician trainees, and other healthcare workers at Lucile Packard Children's Hospital (LPCH) and affiliated facilities who communicate with patients daily will be included
Key exclusion criteria (4 listed)
- Participants with reported severe motion sickness
- Nausea
- Seizure disorder
- Currently using chronotropic heart medications, such as β blockers
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 |
|---|---|---|
| Augmented Reality HeadsetAugmented simulation of workplace-related scenarios of pre-recorded videos using the same actors | Behavioural | Augmented Reality Enhanced Simulation (Treatment group) |
Primary outcome
Parasympathetic response indexed by RSA
Time frame: Duration of simulation (15-20 minutes)
Measured via respiratory sinus arrhythmia (RSA) in hertz using chest biometric sensors in 30-second epochs.
4 secondary outcomes
Sytem Usability Scale (SUS)
Time frame: Post-simulation (5 minutes)
ISO 9241-400
Time frame: Post-simulation (5 minutes)
Simulation Design Scale (SDS)
Time frame: Post-simulation (5-10 minutes)
Learning effectiveness
Time frame: 5 months-post simulation (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 2 Jan 2024.
- Derived from this study: PubMed 40207076Rama A, Rojas-Pino MS, Wang EY, Rodriguez ST, Suen MY, Titzler JS, Zuniga-Hernandez M, Jackson C, Rosales O, Collins F, Caruso TJ. The Physiologic Effect of Augmented Reality Simulation Versus Traditional Simulation: A Noninferiority, Randomized Controlled Trial. J Educ Perioper Med. 2025 Apr 8;27(1):E740. doi: 10.46374/VolXXVII_Issue1_Rama. eCollection 2025 Jan-Mar.
- Individual participant dataSharing planned: No
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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.
Thomas J Caruso, MD, MEd principal investigator
clinical professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented Reality Headset in people with Augmented Reality, 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 1 inclusion and 4 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 2 Jan 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 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?
Parasympathetic response indexed by RSA (time frame: Duration of simulation (15-20 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 NCT05674188, which also lists 1 linked publication.
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 2 Jan 2024.