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

NCT06144658 | Completed

• 1 other identifier: ID RCB 2019- A03007- 50
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Instructional Virtual Realities; Weightlessness Simulation; Space Simulation; Patient Simulation; High Fidelity Simulation Training

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

Augmented Reality Headset Usability

EXPERIMENTAL

In this arm, participants tested the functionality and usability of the headset (a Microsoft Hololens 2 or a Varjor XR3)

Device: Augmented Reality Headset / Hololens 2 or Varjo XR3

Interventions

Augmented Reality Headset / Hololens 2 or Varjo XR3 DEVICE

Augmented Reality Headset

Augmented Reality Headset Usability

Eligibility Criteria

• Age: 18 Years - 66 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Groupe Hospitalier de Bretagne Sud: lead

Study Sites (1)

Groupe Hospitalier de Bretagne Sud

Lorient, 56100, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 22, 2023
• Study Start: October 1, 2020
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Access Criteria: on request

Locations

FR (1)