A Study of the Impact of a Virtual Reality Medical Device (HypnoVR® Headset) on Anxiety and Pain in Interventional Radiology.
- Sponsor
- University Hospital, Clermont-Ferrand
- Study ID
- NCT07668050
- Status
- Not Yet Recruiting
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Conditions
- Anxiety
- Pain
- Radiology, Interventional
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- 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.
Study Details
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 Dates
- First listed
- Jun 25, 2026
- Start date
- Jun 30, 2026
- Status verified
- Mar 2026
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 70 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Virtual Reality GroupParticipants receive immersive virtual reality during the interventional radiology procedure in addition to standard care.
- No Intervention: Control GroupParticipants receive standard care during the interventional radiology procedure without immersive virtual reality.
Primary Outcome Measure
Change in Procedural Anxiety and Procedural Pain [ Time Frame: From immediately before the procedure to immediately after the procedure ]
Central Contacts
- Lise Laclautre0473754963
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