Surgery and Virtual Reality: Interest of Virtual Reality in Oncology for Procedures Under Local Anesthesia in the Operating Room

Description of the modalities for recruiting :

During the preoperative consultation, the surgeon or anesthesiologist presents the study to the patient with a cancer requiring a surgery under local anesthesia. He gives the patient the consent form to participate in the study.

Once the consent form has been signed by the patient and the investigator, the investigator prescribes a screening test before surgery.

Patients registration and randomization :

Any patient who has signed an informed consent form (ICF) must be registered in the eCRF in order to be assigned a patient number.

Randomization will be centralized and performed via the eCRF. Patients will be randomly assigned (1:1) at the latest on the day of the surgery.

Experimental group : Local anaesthesia + virtual reality versus Control group : Anesthesia only.

Surgery period :

Regardless of the group, all patients :

• Will receive local anaesthesia according to the standard procedure required for the operation
• Hemodynamic parameters will be measured
• Will be questioned before, immediately after, and at a distance from the surgical procedure on their state of anxiety and immediately after the surgical procedure on the maximum pain felt during the procedure,
• Will be questioned on their satisfaction at the end of surgery.

ANI will be measured before, during and after the operation in patients included at the Saint Herblain site.

A virtual reality headset will be positioned on the patient before the start of the surgical procedure.

Inclusion criteria

• Patient aged 18 or more
• Patient eligible for surgery under local anaesthesia in the operating room
• Written informed consent obtained from the patient
• Patient has valid health insurance

Exclusion criteria

• Surgical procedure requiring complementary anaesthetic products such as intravenous sedation, nitrous oxide
• Patient requiring an epidural, a paravertebral block
• Patient with known allergy(ies) to local anaesthetics
• Patient with schizophrenia, seizure disorder
• For the investigation site with PhysioDoloris monitor (MDMS): Patient with contraindications to ANI monitoring:

Known heart rhythm disorder (complete arrhythmia by atrial fibrillation) Pacemaker Apnea

• Administration of a sedative premedication in the 6 hours before the surgery
• Visually or hearing impaired patient without a hearing aid
• Patient deprived of liberty or under guardianship