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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
The relaxation sessions comprise an introduction in 3 relaxation techniques conducted by a mind-body therapist: "Body Scan", mindfulness meditation and imagination. Patients also receive a CD with different relaxation exercises and the instruction to exercise daily at home for at least 15 minutes.
The acupuncture treatment comprises needling of 6 standardized acupoints: Pericardium 6, Stomach 36, Large intestine 4, Spleen/Pancreas 10, Dumai 20, Liver 3, Shenmen. Additional points can be chosen individual.
Department of Senology, Kliniken Essen-Mitte
Essen, Germany
presurgical psychological distress
Measured by 100mm visual analog scale 1 day pre surgery
Time frame: expected average of 13 days
postsurgical pain
Measured by 100mm visual analog scale 1 day post surgery
Time frame: expected average of 15 days
postsurgical psychological distress
Measured by 100mm visual analog scale 1 day post surgery
Time frame: expected average of 15 days
postsurgical psychological distress
Measured by 100mm visual analog scale 1 week post surgery
Time frame: expected average of 21 days
postsurgical pain
Measured by 100mm visual analog scale 1 week post surgery
Time frame: expected average of 21 days
postsurgical nausea
Measured by 100mm visual analog scale 1 day post surgery
Time frame: expected average of 15 days
postsurgical nausea
Measured by 100mm visual analog scale 1 week post surgery
Time frame: expected average of 21 days
postsurgical fatigue
Measured by 100mm visual analog scale 1 day post surgery
Time frame: expected average of 15 days
postsurgical fatigue
Measured by 100mm visual analog scale 1 week post surgery
Time frame: expected average of 21 days
intraoperative analgesia use
intraoperative analgesia use is taken from operative logs
Time frame: expected average of 14 days
intraoperative anesthesia use
intraoperative anesthesia use is taken from operative logs
Time frame: expected average of 14 days
postoperative analgesia use
postoperative analgesia use is taken from medical records
Time frame: expected average of 15 days
immunemodulation
natural killer cell activity is measured at begin of surgery
Time frame: expected average of 14 days
immunemodulation
natural killer cell activity is measured at end of surgery
Time frame: expected average of 14 days
Number of patients with adverse events
Number of patients with adverse events are measured one week post surgery
Time frame: expected average of 21 days
presurgical psychological distress
Measured by Profile of Mood States (POMS) 1 day pre surgery
Time frame: expected average of 13 days
postsurgical psychological distress
Measured by Profile of Mood States (POMS) 1 day post surgery
Time frame: expected average of 15 days
postsurgical psychological distress
Measured by Profile of Mood States (POMS) 1 week post surgery
Time frame: expected average of 21 days
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