A Study of the Impact of a Virtual Reality Medical Device (HypnoVR® Headset) on Anxiety and Pain in Interventional Radiology.
Starting soon · Not applicable
Conditions studied: Anxiety, Pain, Radiology, Interventional
In brief
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.
Key facts
- Study ID
- NCT07668050
- Run by
- University Hospital, Clermont-Ferrand
- People needed
- 70
- Starts
- 2026-06-01
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-06-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- CHU Clermont-Ferrand — Clermont-Ferrand, France
Full record on ClinicalTrials.gov
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