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临床试验/NCT02892825
NCT02892825已完成不适用

Impact of Music on Hypertension During Cataract Surgery Performed Under Topical Anaesthesia

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 313 人开始时间: 2017年2月2日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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