Pilot Study on the Evaluation of the Effectiveness of a Virtual Reality Device on Anxiety During Procedural Sedation in Traumatology in Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Difference in anxiety level
研究概览
简要总结
The aim of this study is to evaluate the efficiency of a reality device and a virtual hypnosis software to reduce the anxiety during reduction procedure in traumatology in an emergency department. These devices have recently been evaluated in the management of pain and anxiety in different specialties but never in the context of analgesia-sedation protocols in emergencies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patient aged 18 years or older
- •Patient suffering from one of the following traumatic pathologies requiring a technical procedure in the emergency room Shoulder dislocation Ankle dislocation Elbow dislocation Wrist dislocation Reducible fractures
- •No contraindication to Virtual Reality
- •No contraindication to morphine, ketamine, propofol, paracetamol, nefopam and MEOPA
- •Patient having given oral, free and informed consent
排除标准
- •Patients suffering from mono or binocular blindness
- •Patient under the influence of alcohol or psychotropic drugs
- •Patient presenting a psychosis and/or a state of agitation, and/or a state of confusion.
- •Patient presenting a hemodynamic, respiratory or neurological failure
- •Patient with at least one of the following symptoms at the time of inclusion in the study: headache, dizziness, nausea, vomiting
- •Persons benefiting from reinforced protection, i.e. minors, persons deprived of their liberty by a judicial or administrative decision, adults under legal protection (guardianship and trusteeship) and finally patients in a vital emergency situation.
- •Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception (hormonal/mechanical: per os, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy)
- •Concurrent participation in another clinical research study whose objective is the evaluation of anxiety and/or pain
结局指标
主要结局
Difference in anxiety level
时间窗: 30 minutes
Difference in anxiety level measured with a visual analog scale between T1 (before the analgesia-sedation procedure) and T4 (30 minutes after the procedure was performed, by asking the patient to rate the anxiety he or she felt during the procedure) during a technical procedure in traumatology in the emergency department in the VR group compared with the control group. The level of anxiety is measured with a visual analog scale (0: no anxiety, 10: maximum anxiety).
次要结局
- Evaluation of satisfaction(30 minutes)
- Difference in pain intensity(30 minutes)
- Occurrence of headache, nausea/vomiting, dizziness or confusional episode(During the procedure)
- Doses of analgesics(During the procedure)