Augmented Reality Medical Simulation

Sponsor

Stanford University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04376255

Collaborator

(none)

150

Enrollment

Location

Arm

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In order to improve the quality of care we provide to patients, medical trainees need to experience low incident, high mortality events in a safe learning environment. There is a selection bias for predisposing characteristics of health care providers, as most people who have pursued a career in medicine are motivated to learn how to manage medical emergencies. Resources have been traditionally enabled with conventional simulation centers or mobile simulation units. However, these are costly and difficult to access. The purpose of this study is to evaluate a mixed reality alternative to conventional simulation. The need for this is inherent in becoming a medical provider and use of these resources will improve health practices and health services.

Condition or Disease	Intervention/Treatment	Phase
Educational Problems	Other: Augmented Reality (AR)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Augmented Reality Medical Simulation: A Multi-Collaborative Study of Acceptance and Usability

Actual Study Start Date :

Aug 18, 2020

Anticipated Primary Completion Date :

Aug 18, 2023

Anticipated Study Completion Date :

Aug 18, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mixed Reality Simulation Participants in the experimental arm will be introduced to workplace training modules through an Augmented Reality (AR) headset.	Other: Augmented Reality (AR) AR headset - a device that the participants will wear over their head and eyes and will add holographic elements to a live view of workplace training scenario

Arm

Intervention/Treatment

Experimental: Mixed Reality Simulation

Participants in the experimental arm will be introduced to workplace training modules through an Augmented Reality (AR) headset.

Other: Augmented Reality (AR)

AR headset - a device that the participants will wear over their head and eyes and will add holographic elements to a live view of workplace training scenario

Outcome Measures

Primary Outcome Measures

Qualitative Interview Assessment of Remote Simulations [Post-Simulation, Approximate time duration (3-5 minutes)]
Primary Aim: The primary aim is to study the acceptance of AR simulation among anesthesia residents using the Technology Acceptance Model (TAM)

Secondary Outcome Measures

System Usability Scale (SUS) Questionnaire [Post-Simulation, Approximate time duration (3-5 minutes)]
The first secondary aim is to evaluate AR simulation usability via the System Usability Scale (SUS) and ISO 9241-400 Assessment of human-ergonomic factors.
Ergonomic Survey [Post-Simulation, Approximate time duration (3-5 minutes)]
: The final secondary aim will evaluate the ergonomics of the headset via the ISO 9241-400 Assessment of human-ergonomic factors.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Trainees or personnel working and/or volunteering at Lucile Packard Children's Hospital Stanford / Stanford Health Care facilities
18 years and older

Exclusion Criteria:

Have a history of severe motion sickness
Currently have nausea
History of seizures
Are clinically unstable
Currently using corrective glasses (not compatible with AR headset)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lucile Packard Children's Hospital Stanford	Palo Alto	California	United States	94303

Sponsors and Collaborators

Stanford University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Thomas Caruso, Clinical Associate Professor, Stanford University

ClinicalTrials.gov Identifier:

NCT04376255

Other Study ID Numbers:

55657

First Posted:

May 6, 2020

Last Update Posted:

Aug 10, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Thomas Caruso, Clinical Associate Professor, Stanford University

Augmented Reality

Simulation

Education

Study Results

No Results Posted as of Aug 10, 2022