跳至主要内容
临床试验/NCT05289999
NCT05289999招募中不适用

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

Centre Hospitalier le Mans1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年6月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
70
试验地点
1
主要终点
Evaluation of peri-procedural anxiety when performing epidural injections through the sacrococcygeal hiatus

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Using the virtual reality headset for the first injection

Experimental

Performing the first ultrasound-guided epidural injection through the sacrococcygeal hiatus using the virtual reality headset, then the second injection following the usual conditions of care without the device

干预措施: Virtual reality headset for first injection (Device)

Using the virtual reality headset for the second injection

Experimental

Performing the first ultrasound-guided epidural injection through the sacrococcygeal hiatus following the usual conditions of care, then the second injection using the virtual reality headset

干预措施: Virtual reality headset for second injection (Device)

结局指标

主要结局

Evaluation of peri-procedural anxiety when performing epidural injections through the sacrococcygeal hiatus

时间窗: Day 7

Peri-procedural anxiety was measured with State and Trait Anxiety Index (STAI)

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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