Infiltration in Rheumatology With 3D Virtual Reality Headset Pilot Study for the Evaluation of Satisfaction (ICARE)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Infiltration. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Infiltration in Rheumatology With 3D Virtual Reality Headset Pilot Study for the Evaluation of Satisfaction and Feasibility According to Location (Icare)
Обзор
This study is to evaluate the satisfaction and feasibility according to the location of the use of a 3D virtual reality headset during an infiltration in rheumatology.
Подробное описание
The performance of infiltrative procedures in rheumatology is common, even daily, practice. It may be associated with anticipatory anxiety and pain (for example, during a shoulder infiltration, there is a significant difference between anticipated pain and pain felt with a visual analogue scale of 6.03 versus 3.17, P \< 0.001) as well as pain and anxiety during the procedure. Certain techniques are used to limit this anxiety and pain in common practice such as explaining the procedure before and during its performance, the atmosphere (particularly musical atmosphere) and decoration of the room where the procedure takes place (relaxing images visible to the patient, brightness, people present) and the attitude of the practitioner. More recently, hypnosis and/or 3D virtual reality techniques using a virtual reality headset have been implemented in medicine and particularly in rheumatology to help manage chronic or acute pain. Thus, we currently use a virtual reality headset associated with hypnotic induction (using an audio headset) for the performance of many infiltrative procedures. However, there is no data concerning the acceptability and satisfaction of the patient and the physician of the addition of this technique (VR headset with hypnotic induction) nor its feasibility in current practice (extension of the procedure time for example), during an infiltration nor to know if these data can vary according to the infiltrated location.
Первичные конечные точки
- To assess patient satisfaction with the use of 3D virtual reality with hypnotic induction during infiltration using Modified Client satisfaction score (CSQ-8) [Срок оценки: day one]
Вторичные конечные точки (8)
- To assess investigator satisfaction [Срок оценки: Day one]
- To Modified Client satisfaction score (CSQ-8) score according to the location of the infiltration [Срок оценки: Day one]
- Assess the patient's anxiety during infiltration using a numerical scale [Срок оценки: day one]
- To Assess the patient's pain during the infiltration using a numerical scale. [Срок оценки: day one]
- To Compare pain during infiltration to anticipated pain from infiltration using a numerical scale [Срок оценки: day one]
- Evaluate the added duration of the gesture by using the virtual reality headset [Срок оценки: day one]
- Compare the duration of the gesture with hypnotic 3D virtual reality versus the assumed duration without the use of the headset [Срок оценки: day one]
- Describe the tolerance of the Virtual Reality headset [Срок оценки: day one]
Критерии участия
Критерии включения
- 18 years or older
- Patient requiring infiltration of the spine (high epidural or sacrococcygeal hiatus) of the subacromial-deltoid bursa or the knee, regardless of the product infiltrated
- Within the Rheumatology department of Saint-Antoine hospital (consultation or hospitalized)
Критерии исключения
- History of severe psychiatric disorders - History of epilepsy
- Cognitive disorders
- Language barrier - Hearing aid-assisted deafness and/or ophthalmological problems leading to a major loss of vision (advanced cataract, visual impairment)
- Infiltration of the spine (high epidural or sacrococcygeal hiatus), subacromial-deltoid bursa or knee < 6 months
- Characterized depressive disorder diagnosed recently (for less than 6 months) or not stabilized
- Previous use of a virtual reality headset during treatment
- Being under guardianship or curatorship
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Франция · 1 центр
- Rheumatology department Hôpital Saint Antoine — Paris
Идентификаторы
NCT: NCT07103096 · APHP250404 · IDRCB 2025-A00458-41