Effects of Preoperative Relaxation and Intensified Surgery Education on Preoperative Wellbeing and Postoperative Complaints in Patients Undergoing Colorectal Surgery - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 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 colorectal surgery.
详细描述
A former pilot study has shown that a preoperative relaxation program was effective in reducing preoperative anxiety. However the intervention was biased by concurrent pre-surgery education. Therefore 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 colorectal surgery using a factorial design.
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
- •referral for colorectal surgery
- •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
- •known 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 nausea(10 days after surgery)
- postoperative disability(10 days after surgery)
- preoperative anxiety(day of surgery)
- postoperative fatigue(10 days after surgery)
- postoperative complications(10 days after surgery)
- Satisfaction with care(10 days after surgery)
- Satisfaction with interventions(10 days after surgery)
研究者
Gustav Dobos
Principle Investigator
Universität Duisburg-Essen