Virtual Reality in Awake Surgery : Pilot Study VIRAS

Regional University Hospital Center (CHRU)

Status: Enrolling

Conditions: Surgery

Treatments: Other: Patient state of anxiety; Other: Monitoring of the device; Other: Training session with the virtual reality mask; Other: Acceptability of the device

Study type: Interventional

Funder types: Other

Identifiers

NCT05151822

29BRC21.0039 (VIRAS)

Details and patient eligibility

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Virtual reality mask

Experimental group

Description:

Realization of the following examinations with virtual reality mask : * Training session * Acceptability of the device before and after surgery * Monitoring of the device during surgery

Treatment:

Other: Acceptability of the device

Other: Training session with the virtual reality mask

Other: Monitoring of the device

Other: Patient state of anxiety