Effect of Virtual Reality Distraction in Reducing Patients' Pain and Anxiety During Peripheral Arterial Angioplasty: a Randomized Prospective Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Numerical Rating Scale (NRS)
研究概览
简要总结
Peripheral arterial disease can cause serious leg pain and discomfort. During treatment with angioplasty, patients often feel pain and anxiety because the procedure is usually done with local anesthesia and no sedation. Virtual reality (VR) may help reduce these feelings by distracting patients.
This study will test whether using VR glasses during peripheral angioplasty can lower patients' pain and anxiety. Patients will be randomly divided into two groups: one will use VR, the other will not. Pain and anxiety will be measured at different times during the procedure. The need for extra pain or anxiety medication and overall satisfaction will also be recorded.
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing elective peripheral angioplasty
- •Can cooperate and appropriate for wearing VR glasses
排除标准
- •Undergoing emergency peripheral angioplasty
- •With neurological and psychiatric conditions that prevent reliable assessment of pain or anxiety scores
研究组 & 干预措施
Virtual Reality
Virtual reality glasses will be applied to patients in this group in addition to painkillers
干预措施: Virtual Reality (Other)
Routine treatment group
Patients in this group will be administered painkillers routinely in the hospital.
干预措施: dexketoprofen + midazolam (Drug)
结局指标
主要结局
Numerical Rating Scale (NRS)
时间窗: 1 day
Pain level will be measured with the Numerical Rating Scale (NRS). It ranges between minimum 0 and maximum 10 points. 0 point reffers no pain, 10 points reffer most serious pain.
State Anxiety Inventory-6 (STAI-6)
时间窗: 1 day
Anxiety level was measured with the State Anxiety Inventory-6 (STAI-6). After a correction formula it ranges between minimum 20 and maximum 80 points. 20 points reffer lower anxiety, 80 points reffer higher anxiety.
次要结局
未报告次要终点
研究者
İsmail DAL
Assistant Professor Literally: Doctor Teaching Member
Kastamonu University