Transrectal-ultrasound (TRUS) guided prostate biopsy is among the most common urologic procedures, with over 1 million performed in the United States and Europe each year [1]. Prostate biopsy is usually well-tolerated and safely performed in the outpatient setting, but a substantial proportion of patients experience significant morbidity related to the procedure, including pain, anxiety, and discomfort [1], [2], [3]. Up to 1 in 5 men may refuse a recommended follow-up biopsy, putting them at risk of understaging and adverse oncologic outcomes. Anxiety related to repeated prostate biopsy is the primary reason why patients with low-risk prostate cancer elect for definitive, but potentially unnecessary and harmful, treatment without progression of disease [4], [5], [6].

Given the volume of prostate biopsies performed annually and the associated morbidity, there is a clinical need to develop a low cost, easy to implement intervention that decreases perioperative morbidity. The need to develop such interventions is only likely to increase with the trend towards adoption of transperineal biopsy, a technique under active investigation which may provide superior infection rates postbiopsy, but potentially increased pain and discomfort in the clinic. Brief mind-body intervention programs improve psychological functioning and decrease symptoms of pain, anxiety, and fatigue [7], [8], [9], [10], [11]. In particular, a brief guided mediation intervention has been shown to prevent anxiety, pain, and fatigue in patients treated with image-guided breast biopsy [12].

We hypothesized that a brief guided mind-body intervention would improve patient reported pain, anxiety, discomfort, and tolerability of prostate biopsy compared with usual care and developed a low-cost mind-body intervention delivered via headphones that could be easily implemented on a large scale if proven efficacious. We conducted a clinically-integrated randomized controlled trial nested within a trial of 1-stage versus 2-stage consent to assess the effect of our mind-body intervention versus usual care on patient reported pain, anxiety, discomfort, and intolerability after prostate biopsy.