Awake ProcedureChirEv-RVNCT07830264
Impact of a Preoperative 3D Virtual Reality Immersion Intervention on the Experience of Awake Brain Surgery
A study testing Virtual reality and Questionnaire in people with Awake Procedure and Visual Reality, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Awake surgery for brain lesions located in functional areas is becoming increasingly common in current neurosurgical practice. The principle involves performing intraoperative mapping while the patient is awake, using direct cortical electrical stimulation (DCS) to identify functional areas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Awake Procedure, Visual Reality
- What is being tested?
- Virtual reality and Questionnaire
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 30 Oct 2026to 30 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years or older
- Patient with a lesion located in a functional area requiring an awake procedure
- Patient capable of completing a self-administered questionnaire
- Patient capable of understanding and following study-related information
- Patients who have signed an informed consent form
- Patients covered by or affiliated with a social security scheme
Who cannot join
- Patient with a history of brain surgery
- Patient with a medical contraindication to surgery and/or anesthesia
- Patient with severe respiratory insufficiency
- Patient treated with antipsychotics (neuroleptics or lithium)
- Patient with pre-existing, documented degenerative cognitive disorders (dementia, Alzheimer's, etc.)
- Patient with active substance abuse
Show all 13Show fewer
- Patient unable to complete a self-administered questionnaire independently (inability to read or speak French, severe cognitive impairment)
- Patient with a personal psychiatric history
- Patient with known contraindications to the use of a virtual reality headset
- Legally protected adults (under guardianship or curatorship, etc.) or individuals deprived of liberty by judicial or administrative decision
- Patient unable to provide personal consent or legally protected adult
- Pregnant, breastfeeding, or recently delivered woman
- Individuals simultaneously participating in another study involving human subjects
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marie-Hélène Barba contact
France1 site
Hôpital privé Clairval
Marseille, 13009
Philippe Metellus, Dr, 0033491171483, philippe.metellus@outlook.fr
About this study
Awake surgery for brain lesions located in functional areas is becoming increasingly common in current neurosurgical practice. The principle involves performing intraoperative mapping while the patient is awake, using direct cortical electrical stimulation (DCS) to identify functional areas. While awake during the procedure, the patient is tested on various aspects of language, sensorimotor, or visuospatial cognitive functions. DCS is applied sequentially across different brain regions. A stimulation-which induces "transient electrical and functional disruption"-is considered positive if it interferes with the task the patient is performing. The stimulated region is then deemed essential for the function being tested. Awake surgery thus enables maximal resection of the brain lesion while minimizing the risk of postoperative neurological deficits, thereby improving quality of life.
However, undergoing awake cranial surgery can expose patients to significant psychological stress. This is particularly relevant given that patients with brain lesions exhibit higher levels of psychological distress and are more prone to anxiety and/or depression than patients with tumors in other parts of the body. Assessing patient satisfaction and their subjective experience of this procedure is crucial, as the psychological impact can be profound.
Read more
Only a few studies have evaluated patient preparation for this procedure and the psychological consequences of this unique experience using standardized, validated questionnaires.
Consequently, analyzing the experiences of patients undergoing awake surgery and implementing a preoperative program designed to improve patient preparation-and thus enhance their experience-is essential. Virtual reality (VR) is an advanced technology that allows users to immerse themselves in a computer-generated environment, which may include auditory, 3D visual, and sometimes tactile or olfactory stimuli. This technology generates realistic images that simulate the user's physical presence within a virtual environment. Access to this technology has recently increased. Over the past two decades, VR has been explored as a resource to improve patient care in medical settings, serving as a distraction therapy for pain and anxiety.
Recent studies have highlighted the value of VR as a tool for performing tasks that assess cognitive, visual field, and language functions during the awake phase of surgical procedures. However, its use as a preoperative tool to prepare patients for awake surgery has not yet been tested. Nevertheless, a randomized clinical trial has evaluated the impact of VR as a preoperative tool on anxiety reduction in patients undergoing colorectal cancer surgery. VR was used to present the entire care pathway-from admission to discharge-to the patient. The authors demonstrated a reduction in perioperative anxiety among patients using VR. Consequently, VR appears to be the most suitable tool for developing such a preoperative intervention for awake surgery. It would enable an immersive presentation of the various surgical stages, thereby optimally preparing patients for the procedure and improving their overall experience.
We therefore propose conducting a prospective, interventional, randomized, open-label study to evaluate the impact on the patient experience of a preoperative 3D virtual reality immersion tool that presents the environment, sounds, equipment, and medical personnel involved.
- Conditions
- Awake Procedure, Visual Reality
- Being tested
- Virtual reality, Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityDevice
The immersion involves viewing an immersive 360° video via a VR headset that replicates the surgical journey, featuring a virtual tour of the operating room, explanations of the procedure, and realistic ambient sound.
The immersion lasts 10 minutes.
QuestionnaireOther
- State-Trait Anxiety Inventory form Y
- Hospital Anxiety and Depression Scale
- EORTC quality of life questionnaire C30 : European Organisation for Research and Treatment of Cancer
- Évaluation du Vécu de l'Anesthésie LocoRégionale
- Sleep quality (between 0 and 10)
- pain scale between 0 and 10 during the surgery
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality | Experimental | Not described Receives: Device: Virtual reality; Other: Questionnaire |
| without medical device | Placebo comparator | Not described Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall index of the EVAN-LR questionnaire
EVAN-LR questionnaire : Assessment of the Patient Experience of Locoregional Anesthesia It comprises 19 items grouped into an overall index and five specific dimensions: Attention, Information, Discomfort, Waiting, and Pain. Based on their expectations, patients rate their experience on a scale from 1 (much worse than expected) to 5 (much better than expected). A score difference of more than 5 points is considered clinically relevant (CI: 10 points).
Measured: between day 0 and day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start30 Oct 2026 (estimated)
- Primary completion30 Oct 2029 (estimated)
- Study completion30 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Awake ProcedureStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830264
- Sponsor's protocol ID
- 2025-A02626-43
- Acronym
- ChirEv-RV
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Preoperative 3D Virtual Reality Immersion Intervention on the Experience of Awake Brain Surgery
- ClinicalTrials.gov ID
- NCT07830264
- Acronym / sponsor ID
- ChirEv-RV / 2025-A02626-43
- Conditions
- Awake Procedure, Visual Reality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 30 Oct 2029 (estimated)
- Study completion
- 30 Oct 2029 (estimated)
- First posted
- 21 Sep 2026 (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.
Awake surgery for brain lesions located in functional areas is becoming increasingly common in current neurosurgical practice. The principle involves performing intraoperative mapping while the patient is awake, using direct cortical electrical stimulation (DCS) to identify functional areas. While awake during the procedure, the patient is tested on various aspects of language, sensorimotor, or visuospatial cognitive functions. DCS is applied sequentially across different brain regions. A stimulation-which induces "transient electrical and functional disruption"-is considered positive if it interferes with the task the patient is performing. The stimulated region is then deemed essential for the function being tested. Awake surgery thus enables maximal resection of the brain lesion while minimizing the risk of postoperative neurological deficits, thereby improving quality of life.
However, undergoing awake cranial surgery can expose patients to significant psychological stress. This is particularly relevant given that patients with brain lesions exhibit higher levels of psychological distress and are more prone to anxiety and/or depression than patients with tumors in other parts of the body. Assessing patient satisfaction and their subjective experience of this procedure is crucial, as the psychological impact can be profound.
Only a few studies have evaluated patient preparation for this procedure and the psychological consequences of this unique experience using standardized, validated questionnaires.
Consequently, analyzing the experiences of patients undergoing awake surgery and implementing a preoperative program designed to improve patient preparation-and thus enhance their experience-is essential. Virtual reality (VR) is an advanced technology that allows users to immerse themselves in a computer-generated environment, which may include auditory, 3D visual, and sometimes tactile or olfactory stimuli. This technology generates realistic images that simulate the user's physical presence within a virtual environment. Access to this technology has recently increased. Over the past two decades, VR has been explored as a resource to improve patient care in medical settings, serving as a distraction therapy for pain and anxiety.
Recent studies have highlighted the value of VR as a tool for performing tasks that assess cognitive, visual field, and language functions during the awake phase of surgical procedures. However, its use as a preoperative tool to prepare patients for awake surgery has not yet been tested. Nevertheless, a randomized clinical trial has evaluated the impact of VR as a preoperative tool on anxiety reduction in patients undergoing colorectal cancer surgery. VR was used to present the entire care pathway-from admission to discharge-to the patient. The authors demonstrated a reduction in perioperative anxiety among patients using VR. Consequently, VR appears to be the most suitable tool for developing such a preoperative intervention for awake surgery. It would enable an immersive presentation of the various surgical stages, thereby optimally preparing patients for the procedure and improving their overall experience.
We therefore propose conducting a prospective, interventional, randomized, open-label study to evaluate the impact on the patient experience of a preoperative 3D virtual reality immersion tool that presents the environment, sounds, equipment, and medical personnel involved.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality | Experimental | Device: Virtual reality, Other: Questionnaire |
| without medical device | Placebo comparator | Other: Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient aged 18 years or older
- Patient with a lesion located in a functional area requiring an awake procedure
- Patient capable of completing a self-administered questionnaire
- Patient capable of understanding and following study-related information
- Patients who have signed an informed consent form
Key exclusion criteria (13 listed)
- Patient with a history of brain surgery
- Patient with a medical contraindication to surgery and/or anesthesia
- Patient with severe respiratory insufficiency
- Patient treated with antipsychotics (neuroleptics or lithium)
- Patient with pre-existing, documented degenerative cognitive disorders (dementia, Alzheimer's, etc.)
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 realityThe immersion involves viewing an immersive 360° video via a VR headset that replicates the surgical journey, featuring a virtual tour of the operating room, explanations of the procedure, and realistic ambient sound. The immersion lasts 10 minutes. | Device | Virtual reality |
| Questionnaire* State-Trait Anxiety Inventory form Y * Hospital Anxiety and Depression Scale * EORTC quality of life questionnaire C30 : European Organisation for Research and Treatment of Cancer * Évaluation du Vécu de l'Anesthésie LocoRégionale * Sleep quality (between 0 and 10) * pain scale between 0 and 10 during the surgery | Other | Virtual reality, without medical device |
Primary outcome
Overall index of the EVAN-LR questionnaire
Time frame: between day 0 and day 6
EVAN-LR questionnaire : Assessment of the Patient Experience of Locoregional Anesthesia It comprises 19 items grouped into an overall index and five specific dimensions: Attention, Information, Discomfort, Waiting, and Pain. Based on their expectations, patients rate their experience on a scale from 1 (much worse than expected) to 5 (much better than expected). A score difference of more than 5 points is considered clinically relevant (CI: 10 points).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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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.
Marie-Hélène Barba contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality and Questionnaire in people with Awake Procedure and Visual Reality, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site 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 6 inclusion and 13 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: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-François Oudet (0033683346567, jf.oudet@ecten.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall index of the EVAN-LR questionnaire (time frame: between day 0 and day 6). 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 21 Sep 2026.