CancerBOREVNCT05287854
Surgery and Virtual Reality: Interest of Virtual Reality in Oncology for Procedures Under Local Anesthesia in the Operating Room
A study testing Virtual reality headset in people with Cancer, run by Institut Cancerologie de l'Ouest at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Virtual reality headset
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesFrance
- Study dates
- 16 Jun 2022to 27 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
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.
Read more
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
Read the detailed description
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.
- Conditions
- Cancer
- Being tested
- Virtual reality headset
- Keywords
- Virtual reality, Pain control, Anxiety control, Local anesthesia, Surgery, Operating room, Analgesia Nociception Index (ANI)
- Medical subject headings
- Neoplasms, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality headsetDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Virtual reality headset |
| Local anesthesia alone | No intervention | Patients benefit only from a local anaesthesia is provided according to the standard procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Pain is evaluated in continuous by to the Analgesia Nociception Index (ANI) measured from the PhysioDoloris monitor (MDMS).
It is a unitless index between 0 and 100, which describes:
Pain: 0 ≤ ANI ≤ 40 Discomfort/anxiety: 40 < ANI ≤ 65 Comfort/well-being: 65 < ANI ≤ 100
Measured: 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
Heart rate, blood pressure and respiratory rate measured by a multiparametric monitor type M540
Measured: in preoperative ; during the surgical procedure ; immediate postoperative
Comparison, between the "local anesthesia + virtual reality" group and the "local anesthesia alone" group, of anxiety
Anxiety is measured by a visual analogue scale of 0 to 10. (0 : no anxiety ; 10 : maximum anxiety)
Measured: 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
Satisfaction is evaluated by a Lickert scale (Absolutely satisfied / Somewhat satisfied / Neither satisfied nor dissatisfied / Somewhat dissatisfied / Absolutely dissatisfied)
Measured: immediate postoperative
Comparison, between the "local anesthesia + virtual reality" group and the "local anesthesia alone" group, of operator of the surgical procedure
Satisfaction is evaluated by a Lickert scale (Absolutely satisfied / Somewhat satisfied / Neither satisfied nor dissatisfied / Somewhat dissatisfied / Absolutely dissatisfied)
Measured: immediate postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start16 Jun 2022
- Primary completion27 Jun 2023
- Study completion27 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287854
- Sponsor's protocol ID
- ICO-2021-14
- Acronym
- BOREV
- Status last verified
- Oct 2025
- First submitted
- 18 Jan 2022
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery and Virtual Reality: Interest of Virtual Reality in Oncology for Procedures Under Local Anesthesia in the Operating Room
- ClinicalTrials.gov ID
- NCT05287854
- Acronym / sponsor ID
- BOREV / ICO-2021-14
- Conditions
- Cancer
- Keywords
- Virtual reality, Pain control, Anxiety control, Local anesthesia, Surgery, Operating room, Analgesia Nociception Index (ANI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- 27 Jun 2023 (actual)
- Study completion
- 27 Jun 2023 (actual)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Local anesthesia + Virtual Reality | Experimental | Device: Virtual reality headsetIn addition to local standard anaesthesia, patients benefit from a virtual reality session during the operation using a virtual reality headset |
| Local anesthesia alone | No intervention | –Patients benefit only from a local anaesthesia is provided according to the standard procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality headsetOnce the patient is on the operating table, the nurse proposes the different possible VR scenarios and installs the RV headset and an audio headset. | Device | Local anesthesia + Virtual Reality |
Primary outcome
Comparison, between the "local anesthesia + virtual reality" group and the "local anesthesia alone" group, of the maximum subjective pain induced by the surgical procedure
Time frame: Immediately after surgery
Maximum subjective pain is measured by a numerical pain scale of 0 to 10. (0 : no pain ; 10 : maximum pain)
5 secondary outcomes
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
Time frame: 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
Time frame: in preoperative ; during the surgical procedure ; immediate postoperative
Comparison, between the "local anesthesia + virtual reality" group and the "local anesthesia alone" group, of anxiety
Time frame: 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
Time frame: immediate postoperative
Comparison, between the "local anesthesia + virtual reality" group and the "local anesthesia alone" group, of operator of the surgical procedure
Time frame: immediate postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality headset in people with Cancer, run by Institut Cancerologie de l'Ouest at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison, between the "local anesthesia + virtual reality" group and the "local anesthesia alone" group, of the maximum subjective pain induced by the surgical procedure (time frame: Immediately after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.