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

NCT05287854 | Completed

• 1 other identifier: ICO-2021-14
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief Summary

Virtual Reality (VR) is an interactive and immersive technology that allows you to evolve in a three-dimensional environment created by computer. It appeals to the senses of people by reproducing universes close to reality or imaginary. This process is currently the subject of numerous studies in the field of health because it is a non-invasive tool, a non-pharmacological alternative for the management of pain, anxiety and patient satisfaction. People with cancer can have a complex care pathway with psychological, anxiety-provoking and potentially painful repercussions. It is for these reasons that offering VR in the operating room for certain procedures under local anesthesia would improve the experience and comfort of care. BOREV study will assess the interest of VR on pain for procedures under local anesthesia in the operating room in the context of cancer care. The software used, called HypnoVR©, is a medical device, developed specifically for the management of anxiety and pain through hypnosis, sophrology and relaxation techniques. The main objective of this study is to compare the maximum pain felt with and without RV for different oncological surgical procedures performed under local anesthesia including anesthetic procedures and surgical procedures. The secondary objectives that will support this research are: the evaluation of the level of anxiety, the link with the pain component via the Analgesia Nociception Index (ANI), as well as the satisfaction of the patient and the operator. According to the results obtained, the VR device could lead to a change in practice in the management of patients and thus be offered on a larger scale within the framework of the management of pain and anxiety

Conditions

Cancer

Keywords

Virtual reality; Pain control; Anxiety control; Local anesthesia; Surgery; Operating room; Analgesia Nociception Index (ANI)

Outcome Measures

Primary Outcomes (1)

• Comparison, between the "local anesthesia + virtual reality" group and the "local anesthesia alone" group, of the maximum subjective pain induced by the surgical procedure

  Maximum subjective pain is measured by a numerical pain scale of 0 to 10. (0 : no pain ; 10 : maximum pain)

  Immediately after surgery

Secondary Outcomes (5)

• Comparison, between the "local anesthesia + virtual reality" group and the "local anesthesia alone" group, of the objective pain induced by the surgical procedure in patients with Analgesia Nociception Index

  in preoperative ; during the surgical procedure ; immediate postoperative

• Comparison, between the "local anesthesia + virtual reality" group and the "local anesthesia alone" group, of hemodynamic constants

  in preoperative ; during the surgical procedure ; immediate postoperative

• Comparison, between the "local anesthesia + virtual reality" group and the "local anesthesia alone" group, of anxiety

  in preoperative ; immediate postoperative ; within 30 minutes after the surgery

• Comparison, between the "local anesthesia + virtual reality" group and the "local anesthesia alone" group, of patient satisfaction

  immediate postoperative

• Comparison, between the "local anesthesia + virtual reality" group and the "local anesthesia alone" group, of operator of the surgical procedure

  immediate postoperative

Study Arms (2)

Local anesthesia + Virtual Reality

EXPERIMENTAL

In addition to local standard anaesthesia, patients benefit from a virtual reality session during the operation using a virtual reality headset

Device: Virtual reality headset

Local anesthesia alone

NO INTERVENTION

Patients benefit only from a local anaesthesia is provided according to the standard procedure

Interventions

Virtual reality headset DEVICE

Once the patient is on the operating table, the nurse proposes the different possible VR scenarios and installs the RV headset and an audio headset.

Local anesthesia + Virtual Reality

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead

Study Sites (2)

ICO

Angers, 49055, France

Location

ICO

Saint-Herblain, 44805, France

Location

MeSH Terms

Conditions

Neoplasms; Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: March 18, 2022
• Study Start: June 16, 2022
• Primary Completion: June 27, 2023
• Study Completion: June 27, 2023
• Last Updated: October 7, 2025

Record last verified: 2025-10

Locations

FR (2)