Evaluation of the Interest of a Virtual Reality Headset on Pain and Anxiety During Epidural Injection Through the Sacrococcygeal Hiatus in Patients With Lumbar Radicular Pain.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- CHU de Reims
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- State-Trait Anxiety Inventory
研究概览
简要总结
For a few years, publications have been published concerning the use of virtual reality headsets in the field of medicine and particularly in various specialities.
It has been evaluated in different studies on pain and anxiety in various medical situations.
A study has shown a correlation between a decrease in pain in a clinical way during a painful stimulation and a decrease in certain areas of the brain.
In this context, the use of the virtual reality headset could then be used in medical interventions that may be painful for the patient.
The lumbar radicular pain is a common disease in the world. The epidural injection is one of the treatment of this pathology. He may be performed to reduce the pain but sometimes this act is painful. Most of the time this procedure is performed without premedication.
To the knowledge of the investigators, there are currently no studies on the assessment of pain under a virtual reality headset during the performance of an epidural injection in rheumatology.
The aim of the study is to demonstrate that the Virtual Reality Headset can reduce the pain and the anxiety during an epidural injection.
详细描述
Any patient who meets the inclusion criteria can be offered this study. The physician will verify with the data collected during the usual management of the patient whether the patient presents the inclusion criteria and no exclusion criteria. The questioning (history of the disease, treatments, etc.) and the clinical examination will be carried out within the framework of the usual management of the patient before his inclusion in the study.
After the patient's agreement and signature of the consent form, the patient will be randomized in one of the two groups :
- Group 1: Use of the virtual reality headset during the first epidural infiltration. The second infiltration will be performed without the virtual reality headset.
- Group 2: First epidural infiltration without the virtual reality headset. The second infiltration will be performed with the virtual reality headset.
The duration of participation in each of the two groups is 3 days:
- On the 1st day, the patients will have to fill in a questionnaire with socio-demographic data, pain related to the disease, their anxiety in general life, their anxiety before the infiltration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 18-90 years,
- •Diagnosed with lomboradiculalgia requiring two epidural injection through the sacrococcygeal hiatus,
- •Hospitalized in the Rheumatology Department of the University Hospital of Reims,
- •Speak French language.
- •Affiliated or beneficiary of a social security scheme
- •Having given their written agreement to participate in the study (signature of the consent form)
排除标准
- •Profound or total deafness,
- •Visually impaired,
- •Presence of contraindication to injection,
- •Inability to answer the questionnaire due to severe cognitive impairment,
- •Injection with and without virtual reality headset not performed by the same person,
- •Vestibular pathologies,
- •Epilepsy,
- •Claustrophobia,
- •Use of nitrous oxide for injection.
- •Premedication for infiltration (analgesic, anxiolytic)
- •Patients under guardianship, curatorship, safeguard of justice
- •Pregnant women
- •Psychotic disorders
研究组 & 干预措施
virtual reality - Day1
Use of the virtual reality headset during the first epidural infiltration (Day 1). The second infiltration (Day 3) will be performed without the virtual reality headset.
干预措施: Virtual Reality Headset (Other)
virtual reality - Day3
First epidural infiltration without the virtual reality headset (day 1). The second infiltration will be performed with the virtual reality headset (Day 3).
干预措施: Virtual Reality Headset (Other)
结局指标
主要结局
State-Trait Anxiety Inventory
时间窗: Day 3
STAI-B (trait anxiety), STAI-A (state anxiety)
State-Trait Anxiety Inventory
时间窗: Day 1
State-Trait Anxiety Inventory STAI-B (trait anxiety), STAI-A (state anxiety)
次要结局
未报告次要终点