Study of the Benefits of Virtual Reality Headsets for Reducing Anxiety in Patients Treated for Pleural Effusion or Pneumothorax Using Small-bore Chest Drainage Tubes - eSEDATION
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Pain and Effects of personalized virtual reality
研究概览
简要总结
Pleural effusion and pneumothorax are common conditions encountered in pulmonology departments and may require chest drainage. However, the chest drainage procedure can cause anxiety in patients, leading to discomfort during the procedure. The use of virtual reality (VR) for anxiety reduction has shown promising results in various medical contexts.
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
- 否
入选标准
- •Age ≥ 18 years;
- •Patient requiring Sledinger thoracic drainage for pneumothorax or pleural effusion in the pulmonology department of Nice University Hospital;
- •Patient affiliated with social security;
- •Signature of informed consent.
排除标准
- •Immediate emergency situations;
- •Anxiolytic, antidepressant, or psychotropic treatment already in place;
- •Cognitive, behavioral, or psychiatric disorders;
- •Language barrier;
- •History of chest drainage or chest surgery;
- •Hearing disorders without hearing aids;
- •Vision disorders without corrective lenses (lack of binocular vision, blindness);
- •Psychotic patients or patients diagnosed with psychiatric disorders;
- •History of epilepsy;
- •Current migraine;
- •Patients for whom three-dimensional films are contraindicated (pacemaker or defibrillator);
- •No social security coverage;
- •Patients under guardianship/curatorship.
研究组 & 干预措施
Standard of care
Standard support without reality virtual headset
Reality virtual
Standard support with reality virtual headset
干预措施: Drainage with Headset Hypno VR (Device)
结局指标
主要结局
Pain and Effects of personalized virtual reality
时间窗: 18 months
Compare the effects of personalized virtual reality support, compared to standard support, on pain in patients undergoing chest drainage with numerical pain scale from 0 to 10.
Anxiety and Effects of personalized virtual reality
时间窗: 18 months
Compare the effects of personalized virtual reality support, compared to standard support, on anxiety in patients undergoing chest drainage with numerical anxiety scale from 0 to 10.
次要结局
- Pain assessment with or without VR headset based on heart rate(18 months)
- Pain assessment with or without VR headset based on respiratory rate(18 months)
- Patient satisfaction(18 months)
- Satisfaction of the paramedical team(18 months)