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.
Parallel
Immersive Virtual Reality
DeviceUse of an immersive virtual reality headset during interventional radiology procedures performed under local anesthesia in order to reduce procedural anxiety and pain.
Change in Procedural Anxiety and Procedural Pain
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.
Patient Satisfaction
Patient satisfaction assessed using a numerical rating scale from 0 to 10 immediately after the procedure.
Operator Experience
Operator experience regarding the procedure assessed using a numerical rating scale from 0 to 10 immediately after the procedure.
Procedure Duration
Duration of the interventional radiology procedure, measured in minutes from the beginning to the end of the intervention.
Analgesic Use During the Procedure
Use and type of analgesic medications administered during the procedure.
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