Feasibility Study Evaluating the Silva Module During the Anaesthesiology Consultation Before an Elective Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Evaluate the acceptability and the patient's qualitative reported experience of Silva
研究概览
简要总结
In this feasibility study, feasibility, acceptability and an initial clinical efficacy of the new module of Hypnosis and Virtual Reality (or Digital Sedation), Silva, will be evaluated. This feasibility study meets objectives of Oncomfort's design validation and design verification steps. Silva will be tested on a sample of 10 patients in the environment where the product is intended to be used, a hospital environment. If results do not fit with user needs, design will be adapted according to results and a new phase of design validation will be implemented. The Silva module is a Digital Sedation module designed for management of pain and anxiety in perioperative patients.
详细描述
Subjects will be recruited during the anaesthesiology consultation preparing to an elective surgery.
First, subject will be asked to self-assess anxiety and comfort. In order to evaluate anxiety, subject will use a 0-10 rating Visual Analogue Scale (VAS) where 0 = no anxiety at all, and 10= the worst imaginable anxiety. The same scale will be used to measure the level of comfort where 0 means no comfort at all and 10 very comfortable.
Subject should be positioned laying on a reclining chair during the session. This session will last for 30 minutes. After the experiment, participants will be asked to rate anxiety, level of comfort, level of immersion and dissociation.
Several questions will be asked to the patient to evaluate his/ her experience, the Silva module, and the sensations experienced.
The study will be ended by an evaluation of adverse event (AE) and the evaluation of the caregivers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject more than 18 years old
排除标准
- •Deaf subject
- •Non-proficiency in French (Module language)
- •Psychiatric disorder
- •Head or face wounds
- •Neurological disease
- •Chronic pain and/or chronic analgesics consumption
- •Medication affecting the autonomic nervous system
- •Dizziness
研究组 & 干预措施
Digital sedation
30 minutes Silva module
干预措施: Digital Sedation (Silva) (Device)
结局指标
主要结局
Evaluate the acceptability and the patient's qualitative reported experience of Silva
时间窗: Day 1 of the intervention
questionnaire
次要结局
- Evaluation of agreeability of the Digital Sedation session(Day 1 of the intervention)
- Evaluate Comfort(Day 1 of the intervention)
- Evaluate Anxiety(Day 1 of the intervention)