Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT05151822

Virtual Reality in Awake Surgery : Pilot Study VIRAS

Led by University Hospital, Brest · Updated on 2024-11-22

50

Participants Needed

1

Research Sites

192 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The virtual reality mask is a tool likely to improve the conditions for performing awake surgery: * by improving tolerance for the patient, * by improving ergonomics in the operating room. In order to control the risks as well as possible, the investigators propose to test the equipment on patients who will undergo orthopedic surgery under local anesthesia at the hospital of Brest: the patients operated in orthopedics under local anesthesia are immobile during the procedure. This target population will allow an immersion of the equipment in the operating room, with an awake patient, during a short time (on average 1 hour of intervention) and for a technically light interventional procedure.

CONDITIONS

Official Title

Virtual Reality in Awake Surgery : Pilot Study VIRAS

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult aged 18 to 75 years
  • Able to give consent for the study
  • Eligible for orthopedic surgery under local anesthesia
  • Orthopedic surgery expected to last at least 1 hour
Not Eligible

You will not qualify if you...

  • Younger than 18 years or older than 75 years
  • Known central neurological disease or cognitive impairment
  • Mini-Mental State Examination score below 23 without school certificate or below 27 with school certificate
  • History of vertigo
  • Claustrophobia
  • Visual problems preventing use of the virtual reality mask
  • Contraindication to surgery
  • Receiving outpatient treatment
  • Refusal or inability to consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Pr SEIZEUR Romuald

Brest, France

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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Virtual Reality in Awake Surgery : Pilot Study VIRAS | DecenTrialz