The Influence of Music on Perceived Pain and Levels of Anxiety While Undergoing Transperineal Prostate Biopsy: The VIVALDI Trial.

Background: Music has been shown to reduce pain and anxiety during invasive procedures such as transrectal ultrasound-guided prostate biopsy, but its role during transperineal prostate biopsy (TPBx) has not yet been investigated. Objective: To evaluate the effect of music listening on pain perception, anxiety, and patient satisfaction in men undergoing TPBx in an outpatient setting. Design setting and participants: This was a prospective, monocentric, randomized controlled trial including 103 men with suspected prostate cancer enrolled between March and October 2025. Participants were randomized 1:1 to either a music intervention group (+MUSIC, Intervention: Patients in the +MUSIC group listened continuously to self-selected music during TPBx, while the control group underwent the same standardized procedure without music. Outcome measurements and statistical analysis: Pain was assessed at predefined procedural time points using a visual analog scale (VAS). Distress was measured pre- and post-procedure using the NCCN Distress Thermometer. Secondary outcomes included satisfaction with pain management, willingness to repeat biopsy, anesthetic requirements, and physiological parameters. Between-group comparisons were performed using the Mann-Whitney U test or Fisher's exact test. Multivariable linear regression models were used to identify independent predictors of pain and satisfaction. Results and limitations: Median age was 69 years, and 44% of patients had a Charlson Comorbidity Index ≥1. The +MUSIC group showed significantly lower postprocedural distress (median 1 vs. 2, Conclusions: Music listening during TPBx is a safe, simple, and effective non-pharmacological intervention that significantly reduces pain and anxiety while improving patient satisfaction and procedural experience.