- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06351397
Immersive Mixed Reality Simulation to Evoke Empathy (Empathy)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Palo Alto, California, United States, 94303
- Lucile Packard Children's Hospital Stanford
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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:
- a history of severe motion sickness
- currently have nausea
- have a history of seizures
- are uncomfortable wearing a ~7 pound weighted vest.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mixed Reality Group
In the MR group, the simulation instructor will explain the scope of the simulation embodiment experience and equip a weighted vest on the participant as they are asked to lay on a hospital patient gurney, seated upright.
The participant, who is wearing a weighted vest to simulate an anterior mediastinal mass, will be asked to be seated upright and will view various holograms including vitals monitors, hear hospital related sounds via the headset, and also see additional holographic assets including intravenous polls and a defibrillator as well as experience heat (simulating a fever) from heat lamps.
The simulation instructor will play the role of a physician who is using good communication skills based on the Calgary-Cambridge Guide to review a scripted consent for a high risk biopsy under sedation that may require life saving interventions such as extracorporeal membranous oxygenation (ECMO).
|
Mixed Reality simulation of medical crisis scenarios. MR 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 |
|
Active Comparator: Control
In the control group, there will be no headset, no heat lamps, and no weighted vest and the participant will rely on their imagination to embody the teenager while lying in the simulation room bed while being consented for the same procedure as the MR group.
|
Tradition simulation of medical crisis scenarios.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in self-reported empathy from before and after the simulation
Time Frame: baseline, immediately after the intervention
|
Measured with Jefferson Scale of Physician Empathy for physicians and other practicing health professionals (HP-Version).
The survey contains 20 item with 7-point scale, 1 indicates strongly disagree and 7 indicates strongly agree (a higher number on the scale indicates more agreement).
|
baseline, immediately after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of the CHARM system's usability
Time Frame: immediately after simulation
|
Measured by System Usability Scale (SUS).
The scale has 10 items.
Scores ranges from 1-5 (1 = strongly disagree and 5 = strongly agree)
|
immediately after simulation
|
|
Evaluation of the CHARM system's ergonomics
Time Frame: immediately after simulation
|
Measured by the ISO Ergonomic scale.
The scale has 6 items.
Scores ranges from 1-5 (1 = strongly disagree and 5 = strongly agree)
|
immediately after simulation
|
|
Satisfaction of Design Features of the Simulation
Time Frame: immediately after the intervention
|
Measured by Simulation Design Scale. The simulation design scale consists of 20 items in total. In the first stage, in order to evaluate whether the items used in the simulation method were given in the best way for the participant, they were expressed as strongly disagree, disagree, undecided, agree, strongly agree. The survey contains 20 item with 5-point scale, 1 indicates strongly disagree and 5 indicates strongly agree (a higher number on the scale indicates more agreement). In the second stage, there are statements that will determine the level of importance of the scale items for the participant, not important, partially important, undecided, important, very important. The survey contains 20 item with 5-point scale, 1 indicates not important and 5 indicates very important (a higher number on the scale indicates more important). In the evaluation phase, the scale score is calculated by dividing the total and the total of the sub-dimensions by the number of items. |
immediately after the intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 75021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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
-
Cairo UniversityRecruitingEducational ProblemsEgypt
-
Gunma PAZ CollegeRecruiting
-
Stanford UniversityWithdrawn
-
The University of Texas Health Science Center at...Genentech, Inc.Active, not recruitingEducational ProblemsUnited States
-
Zeynep YılmazCompleted
-
The Cleveland ClinicActive, not recruitingEducational ProblemsUnited States
-
Stanford UniversityCompleted
-
Balikesir UniversityCompletedEducational ProblemsTurkey
-
The Hong Kong Polytechnic UniversityCompletedEducational ProblemsHong Kong
-
Tokat Gaziosmanpasa UniversityCompleted
Clinical Trials on Mixed Reality (MR)
-
Chang Gung Memorial HospitalRecruitingStroke | Cerebrovascular Disorders | Central Nervous System DiseasesTaiwan
-
Hospital Moinhos de VentoBrainlab AG; Magic Leap IncCompletedKidney CancerBrazil
-
Universitat Politècnica de CatalunyaCompletedLow Vision | Low Vision Aids | Low Vision Blindness | Low Vision Digital AssistanceSpain
-
Slb PharmaUniversité de Caen Normandie; NeoXpériences, Carpiquet, FranceNot yet recruitingBrain Diseases | Multiple Sclerosis | Cerebral Palsy | Ischemic Stroke | Head Trauma | Neurological Conditions | Parkinson Disease (PD) | Cerebral AnoxiaFrance
-
University of Alabama at BirminghamFrom The Future LLCCompleted
-
Nanjing First Hospital, Nanjing Medical UniversityCompleted
-
Nanjing First Hospital, Nanjing Medical UniversityCompleted
-
University of NicosiaRecruiting
-
Mahidol UniversityEnrolling by invitationMild Cognitive Impairment (MCI) | Executive DysfunctionThailand
-
Shanghai Chest HospitalRecruiting