Impact of a Preoperative 3D Virtual Reality Immersion Intervention on the Experience of Awake Brain Surgery (ChirEv-RV)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marie-Hélène Barba
- Email: mh.barba@ecten.eu
Study Contact Backup
- Name: Jean-François Oudet
- Phone Number: 0033683346567
- Email: jf.oudet@ecten.eu
Study Locations
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Marseille, France, 13009
- Hôpital privé Clairval
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Contact:
- Philippe Metellus, Dr
- Phone Number: 0033491171483
- Email: philippe.metellus@outlook.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Virtual reality
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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.
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Placebo Comparator: without medical device
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Overall index of the EVAN-LR questionnaire
Time Frame: between day 0 and day 6
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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). |
between day 0 and day 6
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-A02626-43
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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