Interest of the Virtual Reality Headset in the Management of Perioperative Stress in Patients Candidates for Total Thyroidectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 3
- 主要终点
- Change of Anxiety state (STAI-Y scale)
研究概览
简要总结
Study the interest of hypnosis techniques by virtual reality based on the use of a virtual reality headset with the AQUA® application on the reduction of pre-operative stress in patients candidates for total thyroidectomy
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient> 18 years old
- •Man or woman
- •Patient candidate for a total thyroidectomy, or a thyroid totalization
- •Preoperative Euthyroidism
- •Can justify outpatient care: score of the American Society of Anesthesiology (ASA) 1, 2 or 3 stable; accompanied for return at home; can be watched by a loved one the night after returning home; reachable by telephone; living within an hour of transportation from a hospital and having a good level of understanding.
- •No history of parathyroid or recurrent pathology
- •Signature of informed consent before any specific procedure related to the study
- •Subject affiliated with a health security system
排除标准
- •Patient with a submerged goiter (lower edge of the thyroid not seen on the preoperative cervical ultrasound)
- •Patient with uncontrolled infectious pathology
- •Pregnant or breastfeeding woman or lack of contraception during genital activity
- •Patient with illnesses or conditions that hinder their ability to understand follow and / or comply with study procedures
- •Patient with personality disorders and / or psychiatric pathology
- •Patient deprived of liberty or placed under the authority of a guardian
结局指标
主要结局
Change of Anxiety state (STAI-Y scale)
时间窗: Before surgery and up to 2 hours after surgery
The proportion of patients whose pre-operative anxiety state (STAI-Y scale)is improved or stable between before and after the session with virtual reality headset. These two measurements will allow us to appreciate the variations in patient anxiety.
Change of Anxiety state(AE scale)
时间窗: Before surgery and up to 2 hours after surgery
The proportion of patients whose preoperative anxiety state (AE) is improved or stable between before and after the session with virtual reality headset. These two measurements will allow us to appreciate the variations in patient anxiety.
次要结局
- Anxiety evaluation by Amsterdam Preoperative Anxiety and Information Scale (APAIS)(up to 1 month after surgery)
- Pain evaluation (Visual Analog Pain Scale)(up to 1 month after surgery)
- Satisfaction of patients by EVAN-G scale (Evaluation of the General Anesthesia feelings)(Up to 2 hours after surgery)
- Taking of anxiolytics(up to 1 month after surgery)