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临床试验/NCT06144658
NCT06144658已完成不适用

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

Groupe Hospitalier de Bretagne Sud2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
18
试验地点
2
主要终点
Technical validation of the headset in microgravity

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

入排标准

年龄范围
18 Years 至 66 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy male or female volunteers.
  • Aged between 18 and
  • 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.

排除标准

  • 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.

结局指标

主要结局

Technical validation of the headset in microgravity

时间窗: 1 day

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

Usability test HARUS / Form

时间窗: 1 day

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.

NASA-TLX cognitive test

时间窗: 1 day

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)

次要结局

未报告次要终点

研究者

发起方
Groupe Hospitalier de Bretagne Sud
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Seamus Thierry

Medical Doctor

Groupe Hospitalier de Bretagne Sud

研究点 (2)

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