VR-MARS Virtual Reality, Medical Assistance and Rescue for Space

Patient Simulation Clinical Trial

— VR-MARS  

Official title:

VR-MARS Virtual Reality, Medical Assistance and Rescue for Space

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06144658
• Other study ID #: ID RCB 2019- A03007- 50
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: March 30, 2023

Study information

• Verified date: November 2023
• Source: Groupe Hospitalier de Bretagne Sud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

VRMARS is a medical simulation study in microgravity. Healthy volunteers (n=18) test in microgravity the functionnality of an augmented reality headset in which a medical assistance is displayed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 66 Years

Eligibility

Inclusion Criteria:

Healthy male or female volunteers.

• Aged between 18 and 66.
• Not currently pregnant.
• Affiliated to a social security system or, for non-Europeans, holders of a European Health Insurance Card (EHIC).
• Have signed written consent for the study.
• Have passed a standard JAR FCL3 Class 2 (Private Pilot Aptitude) medical examination less than 1 year old. Exclusion Criteria:

On the day of the flight, before the volunteer boards the plane:

• Flu, digestive symptoms (nausea, vomiting), fever.
• Pregnancy: a urine pregnancy test will be performed on the morning of the flight before boarding.
• Altered mental state (flight anxiety, phobia).
• Failure to attend the safety briefing.

During the flight :

• Non-compliance with basic safety instructions.
• Flight-related side effects: fatigue, motion sickness.

Related Conditions & MeSH terms

• High Fidelity Simulation Training
• Patient Simulation

Intervention

Device:
• Augmented Reality Headset / Hololens 2 or Varjo XR3
Augmented Reality Headset

Locations

Country	Name	City	State
France	Groupe Hospitalier de Bretagne Sud	Lorient

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier de Bretagne Sud

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical validation of the headset in microgravity	The participant had to report to the invistigators whether the headset functioned under microgravity. Images superimposed on the real environment had to be correctly placed and stable in zero-G	1 day
Primary	Usability test HARUS / Form	The HARUS (Handheld Augmented Reality Usability Scale) is a questionnaire measuring manipulability -- the ease of handling the HAR system, and comprehensibility -- the ease of understanding the information presented by augmented reality.	1 day
Primary	NASA-TLX cognitive test	The NASA TLX is a subjective, multidimensional assessment tool that rates perceived workload in order to assess a task, system, or team's effectiveness or other aspects of performance (task loading)	1 day