A Study of the Impact of a Virtual Reality Medical Device (HypnoVR® Headset) on Anxiety and Pain in Interventional Radiology.

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.

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).