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, n = 52) or a control group (-MUSIC, n = 51). Baseline clinical, radiological, and demographic characteristics were collected.

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, p = 0.01). Pain scores were significantly lower in the +MUSIC group during local anesthesia (3 vs. 4.5, p < 0.01), periprostatic anesthesia (3 vs. 5, p < 0.01), first biopsy core (3 vs. 5, p = 0.01), and last biopsy core (3 vs. 5, p = 0.02), with no difference in post-micturition pain. The +MUSIC group required less additional sedation (37% vs. 57%, p=0.03) and lower anesthetic doses (p = 0.02). Satisfaction with pain management (5 vs. 3.5, p < 0.001) and willingness to repeat biopsy (4 vs. 3, p < 0.01) were significantly higher in the +MUSIC group. On multivariable analysis, music remained independently associated with reduced pain and increased satisfaction (p ≤ 0.03). Limitations include the single-center design and relatively small sample size.

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.