A Study of the Impact of a Virtual Reality Medical Device (HypnoVR® Headset) on Anxiety and Pain in Interventional Radiology. (HYPNO-VR)

June 25, 2026 updated by: University Hospital, Clermont-Ferrand

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Interventional radiology procedures are frequently associated with significant procedural anxiety and pain, which may negatively affect patient experience, cooperation during the procedure, and overall procedural conditions. Although pharmacological analgesia and anxiolysis are commonly used, non-pharmacological approaches aimed at improving patient comfort are increasingly being explored.

Immersive virtual reality (VR) has demonstrated promising effects on anxiety and pain reduction in several medical and surgical settings. By providing immersive audiovisual stimulation and distraction, VR may reduce the emotional and sensory perception associated with stressful medical procedures. However, data regarding its use in interventional radiology remain limited.

The HYPNO-VR study is a prospective randomized controlled monocentric study evaluating the impact of immersive virtual reality during interventional radiology procedures performed under local anesthesia.

Eligible adult patients undergoing an interventional radiology procedure will be randomized in a 1:1 ratio to either :

  • a virtual reality group receiving immersive VR during the procedure in addition to standard care ;
  • or a control group receiving standard care alone.

The primary objective is to evaluate the effect of VR on procedural anxiety and pain. Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI-Y), including trait anxiety assessment before the procedure and state anxiety assessment immediately before and after the procedure. Procedural pain will be evaluated using a numerical rating scale.

Secondary and exploratory objectives include evaluation of patient satisfaction, operator experience, procedural duration, analgesic use during the procedure, and feasibility of VR integration into routine interventional radiology practice.

The study aims to assess whether immersive VR may represent a simple, feasible, and effective complementary tool to improve patient experience during interventional radiology procedures.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality Group
Participants receive immersive virtual reality during the interventional radiology procedure in addition to standard care.
Device: 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.
Other Names:
  • HypnoVR
No Intervention: Control Group
Participants receive standard care during the interventional radiology procedure without immersive virtual reality.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Procedural Anxiety and Procedural Pain
Time Frame: 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.
From immediately before the procedure to immediately after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction
Time Frame: Immediately after the procedure
Patient satisfaction assessed using a numerical rating scale from 0 to 10 immediately after the procedure.
Immediately after the procedure
Operator Experience
Time Frame: Immediately after the procedure
Operator experience regarding the procedure assessed using a numerical rating scale from 0 to 10 immediately after the procedure.
Immediately after the procedure
Procedure Duration
Time Frame: During the procedure
Duration of the interventional radiology procedure, measured in minutes from the beginning to the end of the intervention.
During the procedure
Analgesic Use During the Procedure
Time Frame: During the procedure
Use and type of analgesic medications administered during the procedure.
During the procedure
Feasibility of Immersive Virtual Reality Use
Time Frame: During and immediately after the procedure
Feasibility of immersive virtual reality use during interventional radiology procedures, assessed descriptively through device-related incidents and interruptions of device use.
During and immediately after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Pascal Chabrot, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 19, 2026

First Submitted That Met QC Criteria

June 19, 2026

First Posted (Actual)

June 25, 2026

Study Record Updates

Last Update Posted (Actual)

June 29, 2026

Last Update Submitted That Met QC Criteria

June 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RBHP 2025 CHABROT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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