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Virtual Reality in Awake Surgery : Pilot Study VIRAS

Recruiting
18 - 75 years of age
Both
Phase N/A

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Overview

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.

Eligibility

Inclusion Criteria :

  • Major subject
  • Consent for the study
  • Patients eligible for orthopedic surgery with local anesthetic block
  • Estimated duration of the Orthopedic surgery of minimum 1 hour

Exclusion Criteria :

  • Age < 18 years, Age > 75 years,
  • Known central neurological pathology/cognitive impairment,
  • Mini-Mental State examination (MMSe) < 23 if no school certificate, < 27 if school certificate,
  • History of vertigo,
  • Claustrophobia,
  • Visual deficit not compatible with the use of the virtual reality mask,
  • Contraindication to surgery,
  • Outpatient treatment,
  • Refusal or inability to consent.

Study details

Surgery

NCT05151822

University Hospital, Brest

27 January 2024

Step 1 Get in touch with the nearest study center
What happens next?
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  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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