A Study of the Impact of a Virtual Reality Medical Device (HypnoVR® Headset) on Anxiety and Pain in Interventional Radiology. (HYPNO-VR)
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.
Обзор исследования
Статус
Вмешательство/лечение
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Lise Laclautre
- Номер телефона: 0473754963
- Электронная почта: promo_interne_drci@chu-clermontferrand.fr
Места учебы
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Clermont-Ferrand, Франция
- CHU clermont-ferrand
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Главный следователь:
- Pascal Chabrot
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Контакт:
- Lise Laclautre
- Номер телефона: 0473754963
- Электронная почта: promo_interne_drci@chu-clermontferrand.fr
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
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).
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Virtual Reality Group
Participants receive immersive virtual reality during the interventional radiology procedure in addition to standard care.
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Use of an immersive virtual reality headset during interventional radiology procedures performed under local anesthesia in order to reduce procedural anxiety and pain.
Другие имена:
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Без вмешательства: Control Group
Participants receive standard care during the interventional radiology procedure without immersive virtual reality.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Procedural Anxiety and Procedural Pain
Временное ограничение: From immediately before the procedure to immediately after the procedure
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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.
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From immediately before the procedure to immediately after the procedure
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Patient Satisfaction
Временное ограничение: Immediately after the procedure
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Patient satisfaction assessed using a numerical rating scale from 0 to 10 immediately after the procedure.
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Immediately after the procedure
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Operator Experience
Временное ограничение: Immediately after the procedure
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Operator experience regarding the procedure assessed using a numerical rating scale from 0 to 10 immediately after the procedure.
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Immediately after the procedure
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Procedure Duration
Временное ограничение: During the procedure
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Duration of the interventional radiology procedure, measured in minutes from the beginning to the end of the intervention.
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During the procedure
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Analgesic Use During the Procedure
Временное ограничение: During the procedure
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Use and type of analgesic medications administered during the procedure.
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During the procedure
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Feasibility of Immersive Virtual Reality Use
Временное ограничение: During and immediately after the procedure
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Feasibility of immersive virtual reality use during interventional radiology procedures, assessed descriptively through device-related incidents and interruptions of device use.
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During and immediately after the procedure
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Соавторы и исследователи
Следователи
- Главный следователь: Pascal Chabrot, University Hospital, Clermont-Ferrand
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- RBHP 2025 CHABROT
Планирование данных отдельных участников (IPD)
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