Preoperative Relaxation Training and Acupuncture to Minimize Perioperative Symptoms in Breast Cancer Patients
- Conditions
- Breast Neoplasms
- Interventions
- Behavioral: relaxation trainingOther: acupuncture
- Registration Number
- NCT02276404
- Lead Sponsor
- Universität Duisburg-Essen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description relaxation training and acupuncture relaxation training 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. relaxation training and acupuncture 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. relaxation training relaxation training Each participant of the experimental group 1 receives 2 one-hour sessions of guided relaxation training prior to surgery. acupuncture 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.
- Primary Outcome Measures
Name Time Method presurgical psychological distress expected average of 13 days Measured by 100mm visual analog scale 1 day pre surgery
postsurgical pain expected average of 15 days Measured by 100mm visual analog scale 1 day post surgery
- Secondary Outcome Measures
Name Time Method postsurgical fatigue expected average of 21 days Measured by 100mm visual analog scale 1 week post surgery
postsurgical psychological distress expected average of 21 days Measured by Profile of Mood States (POMS) 1 week post surgery
postsurgical pain expected average of 21 days Measured by 100mm visual analog scale 1 week post surgery
postsurgical nausea expected average of 21 days Measured by 100mm visual analog scale 1 week post surgery
intraoperative anesthesia use expected average of 14 days intraoperative anesthesia use is taken from operative logs
postoperative analgesia use expected average of 15 days postoperative analgesia use is taken from medical records
intraoperative analgesia use expected average of 14 days intraoperative analgesia use is taken from operative logs
immunemodulation expected average of 14 days natural killer cell activity is measured at end of surgery
Number of patients with adverse events expected average of 21 days Number of patients with adverse events are measured one week post surgery
presurgical psychological distress expected average of 13 days Measured by Profile of Mood States (POMS) 1 day pre surgery
Trial Locations
- Locations (1)
Department of Senology, Kliniken Essen-Mitte
🇩🇪Essen, Germany