Interest of Virtual Reality to Reduce Patient Anxiety During the Placement of a Percutaneous Implantable Port Catheter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Description of Patient's anxiety through his participation
研究概览
简要总结
The Vascular Access Unit (UAV) of the Lyon Sud Hospital Center is the first unit within a French public establishment where the Regional Health Agency (ARS) has authorized that medical procedures for the installation of central venous access be performed by nurses.
The installation of CIP represents an anxiety-provoking step for the patient, because the gesture, which consists of inserting a box under the skin, connected to a catheter, placed in a deep vein, involves uncomfortable, even painful moments. In the UAV, the installation of this device is carried out in the operating room, without premedication and only under local anesthesia. Affected patients usually have a diagnosis of serious illness (oncology).
Virtual Reality (VR) simulates the physical presence of the patient in an environment artificially generated by software. Many applications have already been evaluated in different health sectors, the investigators would like to show its interest in reducing patient anxiety during CIP placement under local anesthesia, without premedication.
The medical device used is Lumeen. It is a Class I medical device software within the meaning of Regulation (EU) 2017/745, CE marked. In the context of research, the Relaxation module is used. This module is the one intended for the management of anxiety and pain induced by medical procedures in adults and children over 6 years of age. It allows to perform immersions in 360° videos in real shots or computer-generated images, accompanied by natural sounds, relaxing music and a relaxation script recorded by hypnotherapists. The duration of an immersion can be adjusted according to the needs of the medical procedure..
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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 ≥18 years old
- •Patient operated on an outpatient basis and available for a phone call between D+1 and D+5
- •Patient operated for a 1st pose of CIP at the UAV
- •Patient whose anxiety measured by ENS Anxiety is at least 4/10 at entry
- •Patient having signed the Informed Consent
- •Patient affiliated to a social security
排除标准
- •Patient not sufficiently fluent in the French language, in the judgment of the investigator, to allow him a good understanding of the implementation and the interest of the virtual reality headset material;
- •Patient with motion sickness;
- •Patient participating in another study who, in the judgment of the investigator, could interfere with the results of this research protocol;
- •Patient deprived of liberty or placed under guardianship or curators;
- •Pregnant or breastfeeding women;
- •Patient with a history of epilepsy ;
- •Patient with a pacemaker or pacemaker;
- •Patient with psychiatric disorders of a psychotic nature in the acute phase or visual hallucinations;
- •Patient under anxiolytic treatment;
- •Patient presenting wounds or infections on the level of the head not allowing the installation of the virtual reality helmet.
研究组 & 干预措施
CIP procedure under virtual reality
CIP procedure under virtual reality
干预措施: Virtual reality (Device)
结局指标
主要结局
Description of Patient's anxiety through his participation
时间窗: through study completion, an average of 5 days
Evaluated by Simple Numerical Scale : Anxiety from 0 to 10
Evolution of Patient's anxiety during the procedure
时间窗: Day 0
Evaluated by Simple Numerical Scale : Anxiety from 0 to 10
次要结局
- Effects of virtual reality on memorization of the gesture(Day 0 (after placing the port) and through study completion between D+1 and D+5)
- Effects of virtual reality on the caregiver's perception of the ease of the gesture(Day 0 (after placing the port))
- Effects of virtual reality on caregiver satisfaction(Day 0 (after placing the port))
- Effects of virtual reality on Pulse(Day 0 (before, during and after placing the port))
- Effects of virtual reality on the pain perceived by the patient;(Day 0 (after placing the port))
- Effects of virtual reality on satisfaction and comfort during installation(Day 0 (after placing the port))
- Effects of virtual reality on the duration of the intervention(Day 0 (after placing the port))
- Effects of virtual reality on Blood Pressure(Day 0 (before, during and after placing the port))
- Effects of virtual reality on the perception of time(Day 0 (after placing the port))