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.
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.
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.
University Hospital, Clermont-Ferrand
Lead sponsor