Effects of Preoperative Relaxation and Intensified Surgery Education on Preoperative Wellbeing and Postoperative Complaints in Patients Undergoing Herniotomy - 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
- preoperative anxiety (State Anxiety (STAI-S)
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 Herniotomy.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •referral for herniotomy
- •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
- •recurrence of inaugural hernia
- •severe comorbidity
- •severy psychological disorders
- •immunosuppression
- •coagulation disorders
研究组 & 干预措施
preoperative relaxation program+preoperative surgery education
preoperative relaxation program AND single education unit
干预措施: surgery education (Behavioral)
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)
结局指标
主要结局
preoperative anxiety (State Anxiety (STAI-S)
时间窗: day of surgery
State Anxiety (STAI-S) (Spielberger 1970)
postoperative pain intensity (numeric rating scale)
时间窗: day after the surgery, before medication
numeric rating scale for pain at rest, pain at mobilization, coughing, washing, breathing and moving
次要结局
- preoperative anxiety Trait Anxiety (STAI-T)(day of surgery)
- preoperative anxiety Anaesthesia- and Surgery-dependent Preoperative Anxiety (ASPA)(day of surgery)
- postoperative disability(10 days after surgery)
- postoperative fatigue Fatigue measured by 0-10 Numeric Rating Scale(10 days after surgery)
- postoperative complications(10 days after surgery)
- preoperative anxiety Amsterdam Preoperative Anxiety and Information Scale (APAIS)(day of surgery)
- postoperative nausea Nausea measured by 0-10 Numeric Rating Scale(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 Fatigue measured by 0-10 Numeric Rating Scale(Day after surgery)
- postoperative fatigue Fatigue measured by 0-10 Numeric Rating Scale(2 days after surgery)
- postoperative nausea Nausea measured by 0-10 Numeric Rating Scale(Day after surgery)
- postoperative nausea Nausea measured by 0-10 Numeric Rating Scale(2 days after surgery)
研究者
Gustav Dobos
Principle Investigator
Universität Duisburg-Essen