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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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Type d'étude

Interventionnel

Inscription (Estimé)

38

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

  • Nom: Jean-François Oudet
  • Numéro de téléphone: 0033683346567
  • E-mail: jf.oudet@ecten.eu

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Réalité virtuelle

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.

  • 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
Comparateur placebo: without medical device
  • 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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Overall index of the EVAN-LR questionnaire
Délai: 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).

between day 0 and day 6

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

30 octobre 2026

Achèvement primaire (Estimé)

30 octobre 2029

Achèvement de l'étude (Estimé)

30 octobre 2029

Dates d'inscription aux études

Première soumission

15 septembre 2026

Première soumission répondant aux critères de contrôle qualité

15 septembre 2026

Première publication (Réel)

21 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

21 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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