Evaluation of the Use of the RELAX® Glasses on the Anxiety of Patients Undergoing Emergency Hand Surgery Under Locoregional Anesthesia Compared to Those Who do Not Use the Glasses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 171
- 试验地点
- 1
- 主要终点
- Change from baseline in visual analogue scale anxiety scores after emergency hand surgery
研究概览
简要总结
More than 90% of hand surgery is performed under local anesthesia and can be a source of anxiety, especially in an emergency context. The management of this intraoperative anxiety is essential for the comfort. The use of a virtual reality headset has shown its effectiveness in reducing anxiety in dental surgery or hand surgery under local anesthesia with the WALANT technique. On the other hand, virtual reality and the use of 3D can cause discomfort and side effects such as nausea and dizziness. It is known that audiovisual distraction also effectively reduces pain and anxiety in patients with fewer side effects.
The investigators have therefore chosen to use the RELAX® glasses. There are no publications examining the effectiveness of positive distraction as a non-pharmacological agent to improve the patient experience during emergency management in the operating room in the context of hand surgery under locoregional anesthesia. The investigatos would like to study its action on the anxiety, pain and global satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients treated for hand surgery under emergency locoregional anesthesia (Wounds, fractures and infections of the hand and wrist).
- •Over 15 years and 3 months of age on the day of inclusion.
- •Patient with written consent or additional parental consent in the case of minor patients.
- •Socially insured patient.
- •Patient willing to comply with all study procedures and duration.
排除标准
- •Medical history contraindicating RELAX glasses: claustrophobia.
- •Known and current alcohol and/or illicit drug abuse that may interfere with patient safety and/or compliance.
- •Any condition that would make the patient unfit for the study: current presence of cognitive impairment (MMS <15), severe psychiatric disorders (bipolar disorder, psychotic disorders according to the DSM-V classification).
- •Pregnant or breastfeeding woman.
- •Patient under court protection.
- •Patient participating in another study.
- •Patient's refusal to use the headset.
研究组 & 干预措施
Group without RELAX® glasses
Group with RELAX® glasses
干预措施: RELAX® glasses (Behavioral)
结局指标
主要结局
Change from baseline in visual analogue scale anxiety scores after emergency hand surgery
时间窗: In the 5 minutes after the end of emergency hand surgery
The visual analogue anxiety scale from 0 to 10, with 0 meaning no anxiety and 10 very high anxiety.
次要结局
- Rate of patients receiving at least one additional analgesic(Immediate after locoregional anaesthesia)
- Rate of patients receiving at least one additional anxiolytic(Immediate after locoregional anaesthesia)
- Overall satisfaction between the group using RELAX glasses and the group following the usual course (without RELAX glasses) measured by a visual analogue scale(Immediate postoperative)
- Variation in pain between entering and leaving the operating theatre between the 2 arms using a visual analogue scale(In the 5 minutes after the end of emergency hand surgery)
- Pre-existing anxiety, only in patients receiving RELAX glasses, measured with the STAI-YB score(7-days after emergency hand surgery)