Infiltration in Rheumatology With 3D Virtual Reality Headset Pilot Study for the Evaluation of Satisfaction and Feasibility According to Location (Icare)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- To assess patient satisfaction with the use of 3D virtual reality with hypnotic induction during infiltration using Modified Client satisfaction score (CSQ-8)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •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)
排除标准
- •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
研究组 & 干预措施
Infiltration
Patient requiring infiltration of the spine (high epidural or sacrococcygeal hiatus) of the subacromial-deltoid bursa or the knee
结局指标
主要结局
To assess patient satisfaction with the use of 3D virtual reality with hypnotic induction during infiltration using Modified Client satisfaction score (CSQ-8)
时间窗: day one
Modified Client satisfaction score (CSQ-8) Minimum value: 0= not satisfied. Maximum value= 4 totally satisfied. Higher score mean better outcome.
To assess patient satisfaction with the use of 3D virtual reality with hypnotic induction during infiltration using Modified Client satisfaction score (CSQ-8)
时间窗: day one
Modified Client satisfaction score (CSQ-8) Minimum value: 0= not satisfied. Maximum value= 4 totally satisfied. Higher score mean better outcome.
次要结局
- Describe the tolerance of the Virtual Reality headset(day one)
- To assess investigator satisfaction(Day one)
- To Modified Client satisfaction score (CSQ-8) score according to the location of the infiltration(Day one)
- Assess the patient's anxiety during infiltration using a numerical scale(day one)
- To Assess the patient's pain during the infiltration using a numerical scale.(day one)
- To Compare pain during infiltration to anticipated pain from infiltration using a numerical scale(day one)
- Evaluate the added duration of the gesture by using the virtual reality headset(day one)
- Compare the duration of the gesture with hypnotic 3D virtual reality versus the assumed duration without the use of the headset(day one)
- To Modified Client satisfaction score (CSQ-8) score according to the location of the infiltration(Day one)
- To assess investigator satisfaction(Day one)
- Assess the patient's anxiety during infiltration using a numerical scale(day one)
- To Assess the patient's pain during the infiltration using a numerical scale.(day one)
- To Compare pain during infiltration to anticipated pain from infiltration using a numerical scale(day one)
- Evaluate the added duration of the gesture by using the virtual reality headset(day one)
- Compare the duration of the gesture with hypnotic 3D virtual reality versus the assumed duration without the use of the headset(day one)
- Describe the tolerance of the Virtual Reality headset(day one)