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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Change in Procedural Anxiety and Procedural Pain [Срок оценки: From immediately before the procedure to immediately after the procedure]

Вторичные конечные точки (5)

• Patient Satisfaction [Срок оценки: Immediately after the procedure]
• Operator Experience [Срок оценки: Immediately after the procedure]
• Procedure Duration [Срок оценки: During the procedure]
• Analgesic Use During the Procedure [Срок оценки: During the procedure]
• Feasibility of Immersive Virtual Reality Use [Срок оценки: During and immediately after the procedure]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• CHU Clermont-Ferrand — Clermont-Ferrand

Идентификаторы

NCT: NCT07668050 · RBHP 2025 CHABROT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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