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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04376255
Other study ID # 55657
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date August 18, 2020
Est. completion date August 18, 2025

Study information

Verified date August 2023
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 150
Est. completion date August 18, 2025
Est. primary completion date August 18, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Lucile Packard Children's Hospital Stanford Palo Alto California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Qualitative Interview Assessment of Remote Simulations Primary Aim: The primary aim is to study the acceptance of AR simulation among anesthesia residents using the Technology Acceptance Model (TAM) Post-Simulation, Approximate time duration (3-5 minutes)
Secondary System Usability Scale (SUS) Questionnaire 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. Post-Simulation, Approximate time duration (3-5 minutes)
Secondary Ergonomic Survey : The final secondary aim will evaluate the ergonomics of the headset via the ISO 9241-400 Assessment of human-ergonomic factors. Post-Simulation, Approximate time duration (3-5 minutes)
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