Effect of Virtual Reality on Perioperative Anxiety, Stress and Pain in Total Hip Arthroplasty: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Anxiety
研究概览
简要总结
The aim of this study is to evaluate Virtual reality (VR) on perioperative anxiety, pain, hemodynamics, and stress hormones in patients undergoing Total hip arthroplasty (THA).
详细描述
VR is a computer technology that provides the feeling of being immersed in a simulated three-dimensional (3D) world where the user may interact with the virtual environment. Clinical studies have shown that VR technology is effective in reducing pain perception and anxiety. It has also been proposed as an effective non-pharmacological alternative for reducing acute procedural pain and providing anxiety relief.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 years or above.
- •Both sexes.
- •The American Society of Anesthesiologists (ASA) physical status I-III.
- •Scheduled for elective THA under spinal anesthesia.
排除标准
- •Cerebrovascular disease.
- •Psychiatric-cognitive dysfunction.
- •Claustrophobia.
- •Deaf and blind patients.
- •Uncooperative.
- •Adrenal insufficiency.
- •Chronic alcohol and substance addiction.
- •Chronic sedative and narcotic use.
结局指标
主要结局
Anxiety
时间窗: 15 min before operation till immediately postoperative.
Each patient will be instructed about the scores; State Anxiety Inventory (STAI-S). The Arabic validated version of STAI-S test will be provided to the patients to determine the anxiety levels. Scores vary between and 20-80 with high scores associated with higher anxiety levels. Patients will be asked to read each statement and then indicate how they were feeling at that moment by marking the appropriate parentheses on the right side of each statement. Anxiety will be measured at baseline (15 min before operation), before spinal anesthesia and immediately postoperative.
次要结局
- Stress measured by blood serum level of cortisol(6 hours postoperative.)
- Patient satisfaction(24 hours after surgery.)
- Total intraoperative haloperidol consumption(Intraoperatively.)
- The degree of postoperative pain(24 hours postoperatively.)
- Heart rate changes(Till the end of surgery.)
- Mean arterial blood pressure changes(Till the end of surgery.)
- Stress measured by Cohen Perceived Stress Scale(15 min before operation till immediately postoperative.)
- Amount of opioid consumption(24 hours after surgery.)
研究者
Mohammed Said ElSharkawy
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine
Tanta University