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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
To assess the contribution of the use of virtual reality glasses on the pain perceived by patients during the installation of an ICP in the operating room under local anesthesia in the patient newly diagnosed with cancer
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 是
入选标准
- •Adult patient over 18 years of age
- •Patient suffering from a cancerous pathology
- •Patient taken care of for the installation of the ICH
排除标准
- •Patient does not speak and understand French
- •Patient who has had a previous ICH installation
- •Patient with cognitive impairment
- •Patient with pain perception disorder
结局指标
主要结局
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.
时间窗: one year
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.
次要结局
- The evaluation criterion will be measured on the Hamilton scale measuring anxiety during an operation.(one year)
研究者
Valérie LOIZEAU
paramedical research coordination
Poissy-Saint Germain Hospital