Interest of the Virtual Reality as an Analgesic Support and in the Management the Pre-procedural Anxiety in Rheumatology

Обзор

As a part of the current rheumatological practice skills, epidural injections through the sacrococcygeal hiatus take part in the strategy for managing radicular diseases. This technical act is easily performed in an outpatient context since it is a brief procedure, performed under clinical and ultrasound control, with good tolerance. Nevertheless, epidural injections by the way of the sacrococcygeal hiatus can be responsible of anxiety for the patient and meet the definition of pain induced by treatment. Among the non-pharmacological methods that can be offered to the patient in this context, hypnosis and distraction allow psycho-corporal support acting on certain factors influencing the painful experience of the gesture: duration of the gesture, calm and pleasant environment, etc... That is the context in which the use of virtual reality is of interest. Its use in supporting procedures generating induced pain has already been evaluated in several studies, in particular in the fields of surgery and anaesthesiology. The use of a virtual reality device also seems suitable in the context of epidural injections, but this theoretical and plausible interest remains to be demonstrated. To our knowledge, the literature on the use of a virtual reality headset to support invasive procedures in rheumatology remains poorly developed. The objective of this study is therefore to assess the interest of using a virtual reality headset in the support of pain relief and the management of peri-procedural anxiety when performing epidural injections through the sacrococcygeal hiatus.

Вмешательства

• Устройство Virtual reality headset for first injection
  Performing the first ultrasound-guided epidural injection through the sacrococcygeal hiatus using the virtual reality headset
• Устройство Virtual reality headset for second injection
  Performing the second ultrasound-guided epidural injection through the sacrococcygeal hiatus using the virtual reality headset

Первичные конечные точки

• Evaluation of peri-procedural anxiety when performing epidural injections through the sacrococcygeal hiatus [Срок оценки: Day 7]

Вторичные конечные точки (8)

• Assessment of the patient's anxiety [Срок оценки: Immediately after intervention]
• Measure of the duration of the intervention [Срок оценки: Immediately after intervention]
• Assessment of patient's pain [Срок оценки: During intervention]
• Evaluation of the patient satisfaction [Срок оценки: Immediately after intervention]
• Evaluation of the practitioner satisfaction [Срок оценки: Immediately after intervention]
• Evaluation of lumbar and radicular pain [Срок оценки: Before intervention]
• Tolerance and Comfort Questionnaire [Срок оценки: Immediately after intervention]
• Record of undesirable events [Срок оценки: Before intervention]

Критерии участия

Критерии включения

• Adult patient (age ≥ 18 years)
• Hospitalized in a day-hospitalization department at the General Hospital of Le Mans
• For whom a diagnosis of radiculalgia with a duration of less than 6 months is made, for which the imaging is compatible with the symptoms according to the clinician's interpretation
• For whom the indication of at least 2 epidural injections by the way of the sacrococcygeal hiatus is retained
• Having never experienced an epidural injection through the sacrococcygeal hiatus
• Patient able and willing to answer the auto-administered surveys
• Person affiliated or beneficiary of a social security
• Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research) after oral and written information

Критерии исключения

• Patient with comorbidity of epilepsy
• Patient with a contraindication to performing epidural injections through the sacrococcygeal hiatus
• Patient suffering from blindness and / or deafness
• Person with a known significant intolerance towards the use of screens and / or virtual reality devices
• Patient receiving benzodiazepines and / or other sedative treatment
• Patient with a known depressive disease followed by a psychiatrist
• Pregnant, breastfeeding or parturient woman
• Person deprived of liberty by judicial or administrative decision
• Person under forced psychiatric care
• Person subject to legal protection
• Person unable to express consent
• Patient who had participated in an interventional study during the last 30 days
• Severely impaired physical and / or mental health which, according to the investigator, may affect the compliance of the study participant

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• Centre Hospitalier Du Mans — Le Mans

Идентификаторы

NCT: NCT05289999 · CHM-2021/S07/08

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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