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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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

38

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Virtuell verklighet

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
Placebo-jämförare: 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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overall index of the EVAN-LR questionnaire
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

30 oktober 2026

Primärt slutförande (Beräknad)

30 oktober 2029

Avslutad studie (Beräknad)

30 oktober 2029

Studieregistreringsdatum

Först inskickad

15 september 2026

Först inskickad som uppfyllde QC-kriterierna

15 september 2026

Första postat (Faktisk)

21 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

21 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

15 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • 2025-A02626-43

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .