A Study of the Impact of a Virtual Reality Medical Device (HypnoVR® Headset) on Anxiety and Pain in Interventional Radiology. (HYPNO-VR)
Patients undergoing interventional radiology procedures frequently experience significant anxiety and procedural pain despite standard care. Virtual reality (VR) has emerged as a promising non-pharmacological tool for anxiety and pain reduction in various medical settings.
The HYPNO-VR study is a prospective randomized controlled trial designed to evaluate the effect of immersive virtual reality during interventional radiology procedures. Participants will be randomized in a 1:1 ratio to either a virtual reality group or a standard care control group.
The primary objective is to assess the impact of VR on procedural anxiety and pain using validated anxiety questionnaires (State-Trait Anxiety Inventory, STAI) and a numerical pain rating scale.
Secondary and exploratory objectives include assessment of patient satisfaction, operator experience, procedural duration, analgesic use, and feasibility of VR integration in interventional radiology practice.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Interventional radiology procedures are frequently associated with significant procedural anxiety and pain, which may negatively affect patient experience, cooperation during the procedure, and overall procedural conditions. Although pharmacological analgesia and anxiolysis are commonly used, non-pharmacological approaches aimed at improving patient comfort are increasingly being explored.
Immersive virtual reality (VR) has demonstrated promising effects on anxiety and pain reduction in several medical and surgical settings. By providing immersive audiovisual stimulation and distraction, VR may reduce the emotional and sensory perception associated with stressful medical procedures. However, data regarding its use in interventional radiology remain limited.
The HYPNO-VR study is a prospective randomized controlled monocentric study evaluating the impact of immersive virtual reality during interventional radiology procedures performed under local anesthesia.
Eligible adult patients undergoing an interventional radiology procedure will be randomized in a 1:1 ratio to either :
- a virtual reality group receiving immersive VR during the procedure in addition to standard care ;
- or a control group receiving standard care alone.
The primary objective is to evaluate the effect of VR on procedural anxiety and pain. Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI-Y), including trait anxiety assessment before the procedure and state anxiety assessment immediately before and after the procedure. Procedural pain will be evaluated using a numerical rating scale.
Secondary and exploratory objectives include evaluation of patient satisfaction, operator experience, procedural duration, analgesic use during the procedure, and feasibility of VR integration into routine interventional radiology practice.
The study aims to assess whether immersive VR may represent a simple, feasible, and effective complementary tool to improve patient experience during interventional radiology procedures.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Lise Laclautre
- Numéro de téléphone: 0473754963
- E-mail: promo_interne_drci@chu-clermontferrand.fr
Lieux d'étude
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Clermont-Ferrand, France
- CHU clermont-ferrand
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Chercheur principal:
- Pascal Chabrot
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Contact:
- Lise Laclautre
- Numéro de téléphone: 0473754963
- E-mail: promo_interne_drci@chu-clermontferrand.fr
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria :
- Age ≥18 years.
- Scheduled to undergo an interventional radiology procedure performed under local anesthesia without sedation.
- Affiliation to a health insurance system.
- Received complete information about the study and provided written informed consent.
- Ability to understand the study information and complete the questionnaires.
Exclusion Criteria :
- Refusal to participate or withdrawal of consent.
- Patients under legal protection preventing valid informed consent according to regulatory requirements.
- Inability to understand study-related information or to use the virtual reality device due to severe visual, auditory, or cognitive impairment, as clinically assessed by the investigator.
- History of photosensitive epilepsy or uncontrolled epilepsy, constituting a contraindication to virtual reality use.
- Known contraindication to virtual reality use (history of severe cybersickness).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Virtual Reality Group
Participants receive immersive virtual reality during the interventional radiology procedure in addition to standard care.
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Use of an immersive virtual reality headset during interventional radiology procedures performed under local anesthesia in order to reduce procedural anxiety and pain.
Autres noms:
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Aucune intervention: Control Group
Participants receive standard care during the interventional radiology procedure without immersive virtual reality.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Procedural Anxiety and Procedural Pain
Délai: From immediately before the procedure to immediately after the procedure
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Evaluation of procedural anxiety using the State-Trait Anxiety Inventory State scale (STAI-Y1) before and after the procedure.
STAI-Y1 scores range from 20 to 80, with higher scores indicating greater anxiety.
Procedural pain is assessed immediately after the procedure using a numerical rating scale ranging from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain.
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From immediately before the procedure to immediately after the procedure
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Patient Satisfaction
Délai: Immediately after the procedure
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Patient satisfaction assessed using a numerical rating scale from 0 to 10 immediately after the procedure.
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Immediately after the procedure
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Operator Experience
Délai: Immediately after the procedure
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Operator experience regarding the procedure assessed using a numerical rating scale from 0 to 10 immediately after the procedure.
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Immediately after the procedure
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Procedure Duration
Délai: During the procedure
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Duration of the interventional radiology procedure, measured in minutes from the beginning to the end of the intervention.
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During the procedure
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Analgesic Use During the Procedure
Délai: During the procedure
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Use and type of analgesic medications administered during the procedure.
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During the procedure
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Feasibility of Immersive Virtual Reality Use
Délai: During and immediately after the procedure
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Feasibility of immersive virtual reality use during interventional radiology procedures, assessed descriptively through device-related incidents and interruptions of device use.
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During and immediately after the procedure
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Pascal Chabrot, University Hospital, Clermont-Ferrand
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RBHP 2025 CHABROT
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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