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临床试验/NCT00806832
NCT00806832已完成不适用

The Effects of Medical Clowning on Blood Pressure and Pulse Rate of Patients Undergoing Cataract Surgery Under Local Anesthesia

HaEmek Medical Center, Israel1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2008年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Blood pressure

研究概览

简要总结

Cataract surgery is the most prevalent surgical procedure. Since most candidates are elderly patients, hypertension is common among these patients. Preoperative anxiety and tension may cause elevation of patient's heart rate and blood pressure and thus expose them to serious potential complications such as stroke and myocardial infarction. Medical clowns are known to reduce preoperative anxiety of both children and their parents. It is possible therefore that medical clown may have such a beneficial effect also on patients scheduled for cataract surgery under local anesthesia.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing an elective, ambulatory cataract surgery (phacoemulsification technique)
  • Surgery planned to be performed under local anesthesia
  • Age > 40 years
  • Patients signed an informed consent

排除标准

  • Hypertensive patients who did not take their prescribed medications on the day of surgery
  • Uncontrolled hypertension during the month preceding the surgery
  • Patients with systolic and diastolic BP values of >190 and 100 mmHg respectively, measured 1hr prior to surgery
  • Patients not suitable for surgery under local anesthesia
  • Patients in whom the planned phacoemulsification technique was converted to either the ECCE or ICCE technique
  • Patients in whom an anterior vitrectomy had to be performed during surgery
  • Patients treated regularly by anti-anxiety or analgetic treatment

结局指标

主要结局

Blood pressure

时间窗: day of surgery

次要结局

  • heart rate(day of surgery)

研究者

申办方类型
Other

研究点 (1)

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