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 — DEVICE
    Use 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 Group
    Participants receive immersive virtual reality during the interventional radiology procedure in addition to standard care.
  • No Intervention: Control Group
    Participants 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

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