Results
anxiety, pain, breast lesion, breast cancer
BREAST CANCER
Patient and lesion characteristics are summarized by study group in Table Patients characteristics*According to Madjar et al. 2006CG and IG appeared to be comparable with regard to most variables of interest (i.e. mean age, STAI-T) with the exception of personal or family history of breast cancer [Overall, BC was diagnosed in 101 (40.4%) women, while 149 (59.6%) women had a benign breast lesion (BBL). More women were diagnosed with BC in the IG (n = 55, 44.0%) versus the CG (n = 46, 36.8%). STAI-T values were comparable in patients with BBL [40.0 (IQR 35.0, 46.0)] and BC patients ]39.0 (IQR 33.0, 47.0)].Patient anxiety was assessed by STAI-S at four different time points: immediately pre-(T1) and post-procedural (T2); immediately pre-(T3) and post-histology (T3). Over all time points, we did not see an association between the intervention and STAI-S scores (point estimate 2% lower scores in the intervention group compared to the control group, 95% CI between 8% lower and 5% higher). With regard to the entire study population, we observed that the post-procedural (T2) and post-histology (T4) STAI-S scores were lower than pre-procedural (T1) STAI-S scores (13% and 17%, respectively) (Table Analysis of STAI-S by time point testing for an interaction between time and assigned conditionSTAI-S at four different time points in STAI-S at the four different timepointsWorries (measured by VAS) during the biopsy procedure were lower in the IG compared to CG (Table Patient worries*Visual analogue scale (VAS): 0: no worries; 10: maximal worries**Immediately before, during and, directly after the biopsy procedure the study nurse asked the patient about her worries on a VAS from 0 to 10: 0: no worries; 10: maximal worriesThe post-procedural questionnaire showed that 72% from the IG and 28.8% from the CG rated the biopsy easier or far easier than expected (Table The pain perceived immediately before and immediately after the biopsy was less in the IG (median VAS 1) than in the CG (median VAS 2) (Table Patient perception of pain associated with the biopsy procedure*Visual analogue scale (VAS): 0: no pain; 10: maximal pain** Immediately before, during and, directly after the biopsy procedure the study nurse asked the patient about her pain on a VAS from 0 to 10: 0: no pain; 10: maximal painRegarding the comprehension of the upcoming biopsy procedure, patients from the IG reported feeling better informed than patients in the CG (Table Patient comprehension*Visual analogue scale (VAS): 0: excellent information; 10: poor informationBased on the post-procedural questionnaire (T2), 54.4% of the CG thought that a brochure explaining the breast biopsy procedure would be helpful (Supplementary material, Table S3). In fact, the median VAS rating for a brochure was 2 ([IQR 1.0, 3.0]), with 0 being extremely helpful and 10 not helpful at all. 95.2% of the IG agreed that the brochure should be handed out to all patients requiring a breast biopsy [VAS of 2, (IQR 1.0, 3.0)].