Entspannung Und Akupunktur Zur Reduktion Perioperativer Symptome Bei Brustkrebspatientinnen- Eine Randomisiert-kontrollierte Interventionsstudie im Kontext Einer Integrativ Onkologischen Versorgung (EARpeS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- presurgical psychological distress
研究概览
简要总结
Breast cancer surgery is associated with presurgical psychological distress and clinically significant side effects including postsurgical pain, nausea and fatigue. A few studies have examined how to intervene to assist women undergoing breast cancer surgery. For example presurgical hypnosis has been proven to decrease side effects and even intraoperative anesthesia use. Besides the more psychologically based interventions there are a few studies suggesting positive effects of acupuncture on pain, anxiety and nausea in surgery patients.This study aims to investigate whether a presurgical relaxation training, acupuncture treatment or a combination of both therapies is able to reduce presurgical psychological distress an postsurgical side effects in breast cancer patients in comparison to usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
relaxation training
Each participant of the experimental group 1 receives 2 one-hour sessions of guided relaxation training prior to surgery.
干预措施: relaxation training (Behavioral)
acupuncture
Each participant of the experimental group 2 receives 3 acupuncture treatments with a semi-standardized acupoint scheme: once a week over 2 weeks and the day before surgery.
干预措施: acupuncture (Other)
relaxation training and acupuncture
Each patient of the experimental group 3 receives 3 acupuncture treatments with a semi-standardized acupoint scheme and 2 one-hour sessions of guided relaxation training prior to surgery.
干预措施: relaxation training (Behavioral)
relaxation training and acupuncture
Each patient of the experimental group 3 receives 3 acupuncture treatments with a semi-standardized acupoint scheme and 2 one-hour sessions of guided relaxation training prior to surgery.
干预措施: acupuncture (Other)
usual care
Patients receive usual senological treatment
结局指标
主要结局
presurgical psychological distress
时间窗: expected average of 13 days
Measured by 100mm visual analog scale 1 day pre surgery
postsurgical pain
时间窗: expected average of 15 days
Measured by 100mm visual analog scale 1 day post surgery
次要结局
- postsurgical fatigue(expected average of 21 days)
- postsurgical pain(expected average of 21 days)
- postsurgical nausea(expected average of 21 days)
- intraoperative anesthesia use(expected average of 14 days)
- postoperative analgesia use(expected average of 15 days)
- intraoperative analgesia use(expected average of 14 days)
- Number of patients with adverse events(expected average of 21 days)
- presurgical psychological distress(expected average of 13 days)
- postsurgical psychological distress(expected average of 21 days)
- immunemodulation(expected average of 14 days)
研究者
Silke Lange
Research fellow
Universität Duisburg-Essen