Impact of Music on Hypertension During Cataract Surgery Performed Under Topical Anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 313
- 试验地点
- 2
- 主要终点
- Hypertensive event
研究概览
简要总结
The purpose of the study is to assess the effect of music therapy on anxiety and hypertension during cataract surgery procedures performed under topical anaesthesia.
详细描述
Cataract surgery is the most frequent surgical procedure performed in Europe, usually done under topical anaesthesia. Restlessness and hypertension are the most frequent medical complications during surgery, potentially leading to surgical complications. Since the surgery is ambulatory and requires the patient's cooperation, heavy intravenous sedation should be avoided. However, this procedure is stressful, with patients experiencing high anxiety due to being awake and aware of the procedure on their eye and equipment. Music therapy may be considered as a non-pharmacologic and non-invasive mean to reduce anxiety and therefore intra-operative hypertension. To assess the effect of music therapy on anxiety and hypertension during cataract surgery procedures under topical anaesthesia, investigators intend to perform a randomized controlled trial. Depending on the results of the study, music therapy may subsequently be replacing the usual premedication before surgery.
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
- Single (Outcomes Assessor)
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 undergoing elective cataract surgery performed under topical anaesthesia
排除标准
- •Non topical anaesthesia
- •Non ambulatory surgery
- •Communication difficulties including language barrier, and mental disorders
- •Age<18yo
- •Hearing impairment
- •Uncontrolled hypertension
结局指标
主要结局
Hypertensive event
时间窗: Intraoperative every 5 minutes
Non invasive measure through blood pressure cuff
次要结局
- Anxiety score before surgery(before surgery)
- Intraoperative surgical complications(during surgery)
- Anxiety score after surgery(after surgery)
- Duration of surgery(after surgery)
