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Clinical Trial

Impact of a Preoperative 3D Virtual Reality Immersion Intervention on the Experience of Awake Brain Surgery

NCT: NCT07830264 · NOT_YET_RECRUITING

NCT IDNCT07830264
StatusNOT_YET_RECRUITING
Start Date2026-10-30
Completion2029-10-30
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche (OTHER)
First posted
Last updated

Brief 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. 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.

Frequently Asked Questions

What is Impact of a Preoperative 3D Virtual Reality Immersion Intervention on the Experience of Awake Brain Surgery?

Impact of a Preoperative 3D Virtual Reality Immersion Intervention on the Experience of Awake Brain Surgery is a clinical trial registered under NCT07830264. Current status: NOT_YET_RECRUITING.

What is the status of NCT07830264?

The current status of NCT07830264 (Impact of a Preoperative 3D Virtual Reality Immersion Intervention on the Experience of Awake Brain Surgery) is: NOT_YET_RECRUITING.

When did Impact of a Preoperative 3D Virtual Reality Immersion Intervention on the Experience of Awake Brain Surgery start?

Impact of a Preoperative 3D Virtual Reality Immersion Intervention on the Experience of Awake Brain Surgery started on 2026-10-30.

Official Source

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