Effects of Preoperative Relaxation and Intensified Surgery Education on Preoperative Wellbeing and Postoperative Complaints in Patients Undergoing Cholcystectomy - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- postoperative pain intensity
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
- 否
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
研究组 & 干预措施
Usual care
Does not receive a specific study intervention
preoperative relaxation program
preoperative relaxation program
干预措施: relaxation program (Behavioral)
preoperative surgery education
single education unit to understand the complete surgical procedures
干预措施: surgery education (Behavioral)
preoperative relaxation program+preoperative surgery education
preoperative relaxation program AND single education unit
干预措施: relaxation program (Behavioral)
preoperative relaxation program+preoperative surgery education
preoperative relaxation program AND single education unit
干预措施: surgery education (Behavioral)
结局指标
主要结局
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
preoperative anxiety
时间窗: day of surgery
State Anxiety (STAI-S) (Spielberger 1970)
次要结局
- preoperative anxiety(day of surgery)
- 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)
- postoperative disability(day after surgery)
- postoperative disability(2 days after surgery)
- postoperative fatigue(Day after surgery)
- postoperative fatigue(2 days after surgery)
- postoperative nausea(Day after surgery)
- postoperative nausea(2 days after surgery)
研究者
Gustav Dobos
Principle Investigator
Universität Duisburg-Essen