- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04591041
HoloSIM: Mixed Reality Medical Student Training in Complex Crisis Scenarios (HoloSIM)
September 10, 2022 updated by: Julian Wiegelmann, Sunnybrook Health Sciences Centre
HoloSIM: The Way Forward in Complex Crisis Training
In this study, Investigators will test a mixed reality software platform to improve and help for teaching and assessment of anesthesia crisis management among medical students.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Julian Wiegelmann
- Phone Number: 4164804864
- Email: julian.wiegelmann@sunnybrook.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4E 3M4
- Recruiting
- Sunnybrook Health Sciences Centre
-
Contact:
- Julian R Wiegelmann, MD
- Phone Number: 416-480-4864
- Email: julian.wiegelmann@sunnybrook.ca
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- University of Toronto Medical student volunteers
Exclusion Criteria:
- Unwilling to enter the study
- Deficit of vision or hearing incompatible with Microsoft Hololens 2 use
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Training by Mixed Reality Simulation
|
Medical students will train via a mixed reality simulated crisis scenario using the HoloSIM software on the Microsoft Hololens 2
|
ACTIVE_COMPARATOR: Training by Mannequin Based Simulation
|
Medical students will train a via traditional mannequin based medical crisis scenario
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anaphylaxis Checklist of Core Decision Making Steps
Time Frame: one week post exposure
|
Expert consensus based checklists of critical scenario actions on a mannequin based crisis scenario.
Student scenario performance graded from 0 to 45, with higher scores representing a better performance.
|
one week post exposure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Usability Score
Time Frame: Immediately after exposure
|
Likert scale (5 point) based assessment of software usability.
Higher scores on a scale of 1 to 5 represent a better software system usability.
|
Immediately after exposure
|
Learning Satisfaction Score
Time Frame: Immediately after exposure
|
Likert scale (5 point) based assessment of learning satisfaction.
Higher scores on a scale of 1 to 5 represent a greater degree of learning satisfaction.
|
Immediately after exposure
|
Time required to complete critical crisis related tasks
Time Frame: one week post exposure
|
Measured time until critical scenario management events occur
|
one week post exposure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 24, 2021
Primary Completion (ANTICIPATED)
April 1, 2023
Study Completion (ANTICIPATED)
April 1, 2023
Study Registration Dates
First Submitted
September 2, 2020
First Submitted That Met QC Criteria
October 15, 2020
First Posted (ACTUAL)
October 19, 2020
Study Record Updates
Last Update Posted (ACTUAL)
September 13, 2022
Last Update Submitted That Met QC Criteria
September 10, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SUN-2124
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Educational Problems
-
Stanford UniversityNot yet recruitingEducational Problems
-
Tokat Gaziosmanpasa UniversityCompleted
-
Sakarya UniversityCompleted
-
Sakarya UniversityCompleted
-
European e-Learning School in Obstetric AnesthesiaFondazione Policlinico Universitario Agostino Gemelli IRCCSEnrolling by invitationEducational ProblemsItaly
-
Pamukkale UniversityCompleted
-
IlumensCompletedEducational ProblemsFrance
-
Ege UniversityCompleted
-
Selcuk UniversityCompletedEducational ProblemsTurkey
-
Seoul National University HospitalSMG-SNU Boramae Medical CenterCompleted
Clinical Trials on HoloSIM Software via Hololens 2
-
Sunnybrook Health Sciences CentreNot yet recruitingEducational Problems | Simulation of Physical Illness | Medical EmergenciesCanada
-
Samsung Medical CenterEnrolling by invitationEducation | NursingKorea, Republic of
-
Samsung Medical CenterCompleted
-
Muğla Sıtkı Koçman UniversityCompletedMusculoskeletal PainTurkey
-
Groupe Hospitalier de Bretagne SudCompletedPatient Simulation | High Fidelity Simulation Training | Instructional Virtual Realities | Weightlessness Simulation | Space SimulationFrance
-
University of CalgaryUnknownFistula | Central Venous Catheter Thrombosis | Nephrostomy; Complications
-
University of MalagaNot yet recruitingMovement Disorders | Shoulder Pain | Virtual RealitySpain
-
Laval UniversityUnknown
-
VA Office of Research and DevelopmentCompletedSleep Apnea | AgeUnited States