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临床试验/NCT02481271
NCT02481271Unknown不适用

Effects of Preoperative Relaxation and Intensified Surgery Education on Preoperative Wellbeing and Postoperative Complaints in Patients Undergoing Cholcystectomy - a Randomized Controlled Trial

Universität Duisburg-Essen2 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2015年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
108
试验地点
2
主要终点
preoperative anxiety

研究概览

简要总结

This study aims to test the effects of a Preoperative Relaxation intervention and an Intensified Surgery Patient Education on pre- and postoperative wellbeing and health in Patients Undergoing Cholecystectomy.

详细描述

see above

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Double (Investigator, 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

  • 18 years old
  • referral for cholecystectomy
  • preoperative anxiety at least 4/10 points on a numeric rating scale
  • physical and mental capability to participant
  • written informed consent

排除标准

  • Emergency surgery
  • malignoma
  • severe comorbidity
  • severe psychological disorders
  • immunosuppression
  • coagulation disorders

结局指标

主要结局

preoperative anxiety

时间窗: day of surgery

State Anxiety (STAI-S) (Spielberger 1970)

postoperative pain intensity

时间窗: day after the surgery, before meditation

numeric rating scale for pain at rest, pain at mobilization, coughing, washing, breathing and moving

次要结局

  • postoperative disability(10 days after surgery)
  • postoperative fatigue(10 days after surgery)
  • postoperative nausea(10 days after surgery)
  • postoperative complications(10 days after surgery)
  • Satisfaction with care(10 days after surgery)
  • Satisfaction with interventions(10 days after surgery)
  • preoperative anxiety(day of surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gustav Dobos

Principle Investigator

Universität Duisburg-Essen

研究点 (2)

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