The Effect of Virtual Reality Glasses on Anxiety During Surgery Under Spinal Anesthesia: A Randomize Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- State Anxiety Test
研究概览
简要总结
The aim of the study is to evaluate the efficacy of virtual reality glasses on anxiety of the patients who underwent operations under spinal anesthesia during peroperative period. Both control group and VR group will be carry out STAI- Traıt anxiety test before operation and trait test after operation. Patients will be perform spinal anesthesia after standard sedation administration. After block reach adequate level for operation patients in VR group will wear the glasses and started to watch a documentary about birds and a sedative music by the headset. Patients in Control group will take standard anesthesia care. Hemodynamic changes (systemic blood pressure, heart rate, respiration rate and pSPO2) will be record in both groups.
详细描述
The ASA score I-III Patients undergoing operation in OR under spinal anesthesia will be included in the study. Patients randomly assigned to VR group or Control Group. Patients will be carry out STAI-Trait Anxiety test preoperatively and second STAI test postoperatively. Spinal anesthesia will be performed after standard iv midazolam administration in both groups. After block reach adequate level for operation patient will wear the glasses and started to watch a documentary about birds and a sedative music by the headset in VR group and patient will take standard anesthesia care in Control group. The hemodynamic variables will be recorded during operation.
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
- •Patients who undergo surgery under spinal anesthesia
- •American Society of Anesthesiologists (ASA) physical status classification I-III
排除标准
- •patients undergo urgent operations
- •patients have psychiatric disorders
研究组 & 干预措施
VR GROUP
Patients watches 3D documentary videos on virtual reality glasses
干预措施: Virtual Reality (Device)
VR GROUP
Patients watches 3D documentary videos on virtual reality glasses
干预措施: Midazolam (Drug)
midazolam
Patients do not watch virtual reality videos but will be administered iv sedative drugs before spinal attempt.
干预措施: Midazolam (Drug)
结局指标
主要结局
State Anxiety Test
时间窗: postoperative 20th min.
State Anxiety test will be perform at postop care unit
次要结局
- Total tolerance time of Virtual Reality glasses(intraoperative)
- incidence of vomiting(intraoperative)
- incidence of nausea(intraoperative)
- incidence of dizziness(intraoperative)
- incidence of headache(intraoperative)
- change in respiratory rate(20th min. intraoperative)
- Postoperative Visual Analog Scale Score(postoperative 20 th min.)
- change in mean arterial pressure(20th min. intraoperative)
- change in heart rate(20th min. intraoperative)
研究者
Ayse Zeynep Turan
Principle Investigator
Derince Training and Research Hospital