Materials and methods
pain, Anxiety, anxiety, abscess
ABSCESS
This prospective multicenter study was approved by the local ethical committee (Ethikkommission Nordwest- und Zentralschweiz; EKNZ 261/12) and was performed from March 2014 through September 2018. Study participants were required to provide written informed consent, understand and speak German and to be scheduled for a breast biopsy. Excluded were patients undergoing the procedure with fine needle aspiration (symptomatic cyst or abscess evacuation), male patients and patients younger than 18 years. We recruited 257 patients from three Swiss teaching hospitals of which seven were excluded due to consent withdrawal and unblinding. Thus, the final study population comprised 250 patients.To examine the effect of the communication training, a sequential study was designed (Fig. Outline of the sequential study design. T: timepoint; Q: questionnaireSubsequently, patients were recruited for participation in the intervention group (IG). They received information on the biopsy procedure by the psychologically trained physicians and a brochure (included as supplemental material) which explained the breast biopsy procedure in detail.To assess anxiety associated with the breast biopsy, all participants filled out the German version of the validated State-Trait Anxiety Inventory (STAI) [All study participants completed a pre- (Q1) and post-procedural (Q2) questionnaire (see Supplementary material) addressing their worries and comprehension regarding the breast biopsy and the level of anticipated and experienced pain. During the biopsy procedure, the study nurses asked the patients to rate their worries and levels of anticipated pain on a visual-analogue-scale (VAS) (see Supplementary material). After the biopsy procedure, the physicians also rated the patient’s worries, pain and satisfaction with the procedure on a VAS (see Supplementary material).Patient characteristics, personal and family history as well as mammographic and sonographic breast density were obtained from the electronic patient chart (ViewPoint®, Version 5: GE Healthcare GmbH).