Immersive Virtual Reality: Use of an immersive virtual reality headset during interventional radiology procedures performed under local anesthesia in order to reduce procedural anxiety and pain.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).
Primary outcome measure(s)
Change in Procedural Anxiety and Procedural Pain — From immediately before the procedure to immediately after the procedure 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.
Trial sites (1)
Facility
City
Region
Status
CHU Clermont-Ferrand
Clermont-Ferrand
France
More University Hospital, Clermont-Ferrand trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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