Effect of VIrtual Reality Spectacles on the Management of Pain and Anxiety (LURVIDOC)
Effect of VIrtual Reality Spectacles on the Management of Pain and Anxiety During the Insertion of the Implantable Catheter Chamber in the Operating Theatre in Cancer Patients
研究概览
详细说明
The insertion of an implantable catheter chamber (ICH) is indicated in the case of prolonged or repeated infusions, particularly when the products injected are toxic to the venous walls, as is the case with cancer chemotherapy.
The insertion of a ICH is carried out in the operating theatre, usually under local anaesthesia. Although this operation is potentially painful and stressful, the question of its perception by the patient has not yet been addressed, nor the relevance of using non-invasive devices to alleviate the pain felt by the patient.
Among the proposals, virtual reality glasses Bliss Solution would be likely to improve patient management when a ICH is performed under local anaesthesia in the operating theatre.
The evaluation will be made on the contribution of the use of the Bliss Solution virtual reality glasses in the management of pain during the installation of an ICH under local anesthesia in the operating room.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：valérie M LOIZEAU, Master
- 电话号码：0139274047
- 邮箱：vloizeau@chi-poissy-st-germain.fr
研究联系人备份
- 姓名：julia M GROSS
- 电话号码：0139274047
- 邮箱：julia.gross@ght-yvelinesnord.fr
学习地点
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Poissy、法国
- 招聘中
- CH Poissy st Germain
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接触：
- Loizeau Valerie
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Adult patient over 18 years of age
- Patient suffering from a cancerous pathology
- Patient taken care of for the installation of the ICH
Exclusion Criteria:
- Patient does not speak and understand French
- Patient who has had a previous ICH installation
- Patient with cognitive impairment
- Patient with pain perception disorder
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：use of virtual reality Bliss Solution
in the experimental arm the patient will receive the usual practice associated with a virtual reality session (20 minutes renewable) in a world chosen with the patient beforehand
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use virtual reality Bliss Solution
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无干预：current practice, without Bliss Solution
patient will receive the usual practice, local anesthesia
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The main assessment criterion is measured using the Visual Analogue Scale (VAS), which allows a self-assessment of the level of pain felt by the patient using a ruler rated from 1 to 10.
大体时间：one year
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At the same the main evaluation criterion is a visual analogue scale (VAS) allowing a self-evaluation of the pain felt by the patient during the surgical intervention.
The patient will rate their pain, on a scale from 0 for no pain to 10 for very severe pain.
the data will be recorded at the time of the patient's installation, during the venipuncture and at the creation of the pocket.
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one year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The evaluation criterion will be measured on the Hamilton scale measuring anxiety during an operation.
大体时间：one year
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The anxiety felt by patients during the operation will be evaluated with the Hamilton Score.The Hamilton Depression Scale is a test for the intensity of anxiety and depressive disorders that can be used by everyone.
It has 14 rated items from 0 to 3. The higher the score, the more severe the anxiety disorders.
The minimum score is 0 and the maximum score is 42.
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one year
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合作者和调查者
调查人员
- 首席研究员：valerie M LOIZEAU、CHI Poissy
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 2020-A00132-37
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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virtual reality Bliss Solution的临床试验
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IRCCS Eugenio Medea招聘中