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

NCT07668050 | Not Yet Recruiting

• 1 other identifier: RBHP 2025 CHABROT
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety; Pain; Radiology, Interventional

Keywords

Virtual Reality; Interventional Radiology; State-Trait Anxiety Inventory; Patient Satisfaction; Non-pharmacological Intervention; Immersive Virtual Reality; Procedural Anxiety; Procedural Pain

Outcome Measures

Primary Outcomes (1)

• Change in Procedural Anxiety and Procedural Pain

  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 Outcomes (5)

• Patient Satisfaction

  Immediately after the procedure

• Operator Experience

  Immediately after the procedure

• Procedure Duration

  During the procedure

• Analgesic Use During the Procedure

  During the procedure

• Feasibility of Immersive Virtual Reality Use

  During and immediately after the procedure

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

Participants receive immersive virtual reality during the interventional radiology procedure in addition to standard care.

Device: Immersive Virtual Reality

Control Group

NO INTERVENTION

Participants receive standard care during the interventional radiology procedure without immersive virtual reality.

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.

Also known as: HypnoVR

Virtual Reality Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain; Patient Satisfaction; Pain, Procedural

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Pascal Chabrot

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

0473754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the intervention, blinding of participants and investigators is not feasible, as the use of the immersive virtual reality headset is directly visible during the procedure.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned in a 1:1 ratio to either an immersive virtual reality group receiving virtual reality during the interventional radiology procedure in addition to standard care, or to a control group receiving standard care alone.

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: June 25, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 29, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)