Virtual Reality in Awake Surgery : Pilot Study VIRAS

Surgery Clinical Trial

— VIRAS  

Official title:

Virtual Reality in Awake Surgery : Pilot Study VIRAS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05151822
• Other study ID #: 29BRC21.0039 (VIRAS)
• Status: Recruiting
• Phase: N/A
• Start date: May 24, 2022
• Est. completion date: February 2025

Study information

• Verified date: February 2023
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

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.

Related Conditions & MeSH terms

• Surgery

Intervention

Other:
• Training session with the virtual reality mask
Patients will have a training session with the virtual reality mask, the day before surgery. The training consists in the realization, by the patient, of a series of language or neuropsychological tests and evaluation of the acceptability of the device by the patient with Visual Analog Scale (device tolerance from 0 (intolerable) to 10 (completely tolerated)).
• Monitoring of the device
In the operating room : installation and per-operative monitoring of the device. If the device was removed, the list of device side effects or surgery-related adverse events that was required discontinuation of the device will be established.
• Acceptability of the device
After the surgery: evaluation of the acceptability of the device by the patient with Visual Analog Scale (device tolerance from 0 (intolerable) to 10 (completely tolerated))
• Patient state of anxiety
Assessing patient's state of anxiety with the State-Trait Anxiety Inventory (STAI) after surgery.

Locations

Country	Name	City	State
France	Pr SEIZEUR Romuald	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerance of minimum 1 hour of the virtual reality mask (realization, by the patient, of a series of of language or neuropsychological tests)	Study the tolerance of the virtual reality mask on patients in the operating room for orthopedic surgery under loco-regional anesthesia. The mask must be maintained during the testing (minimum 1 hour). The testing consists in the realization, by the patient, of a series of language or neuropsychological tests predefined during the preoperative assessment.	1 Day
Secondary	Device-related adverse event	List of device-related adverse events with Simulator Sickness Questionnaire (SSQ). SSQ quantified virtual reality mask sickness with 16 questions on a self-report basis.	1 Day
Secondary	Withdrawal of the device	List of adverse events that required removal of the device (device side effects or surgery-related adverse events that may require discontinuation of the device)	1 Day
Secondary	Device tolerance for the patient	Visual Analog Scale (VAS) of device tolerance from 0 (intolerable) to 10 (completely tolerated), immediately after the training session and at the end of the procedure.	1 Day
Secondary	Device tolerance for the medical staff	Visual Analog Scale (VAS) of device tolerance from 0 (intolerable) to 10 (completely tolerated), to a representative of each profession present in the operating room during the procedure (anesthetist, surgeon, nurse), at the end of the procedure	1 Day
Secondary	Patient state of anxiety	Assessing patient's state of anxiety with the STAI. The State-Trait Anxiety Inventory (STAI) is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. Higher scores are positively correlated with higher levels of anxiety.	1 Day