Skip to content

The Influence of Music on perceiVed paIn and leVels of Anxiety whiLe unDergoing transperIneal Prostate Biopsy: the VIVALDI Trial

The Influence of Music on perceiVed paIn and leVels of Anxiety whiLe unDergoing transperIneal Prostate Biopsy: the VIVALDI Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07234097
Acronym
VIVALDI
Enrollment
78
Registered
2025-11-18
Start date
2025-12-01
Completion date
2026-04-30
Last updated
2025-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Management, Prostate Cancer

Keywords

pain management, prostate biopsy

Brief summary

Prostate biopsy is the key examination for the histological diagnosis of prostate cancer. This procedure can be performed via the transrectal (TR) or transperineal (TP) approach. Current Guidelines recommend the transperineal route because it is associated with fewer infectious complications compared to the transrectal approach. However, when the same type of anesthesia is used, the transperineal approach is more painful. Several strategies have been developed to improve pain management during TR biopsy. Some studies have shown that allowing patients to listen to music during the procedure can reduce perceived pain and stress. However, this effect has never been investigated in TP biopsies, which are now the gold standard and generally more painful than TR biopsies. Primary Objective: To evaluate the reduction in pain levels in patients undergoing transperineal prostate biopsy with the aid of music compared to patients undergoing the same procedure without music. Secondary Objectives: To evaluate the reduction in stress levels related to the procedure in patients undergoing transperineal prostate biopsy with music compared to those without music. To evaluate the reduction in the use of painkillers and sedatives during the procedure in patients undergoing transperineal biopsy with music compared to those without. To assess pain management and procedure tolerability in both groups.

Interventions

OTHERMusic intervention

music during the biopsy

Sponsors

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

Randomized trial

Eligibility

Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Suspected prostate cancer eligible for transperineal prostate biopsy * Patients who have signed informed consent * Age \> 50 years * Male

Exclusion criteria

* patients who have had prostate biopsies in the past

Design outcomes

Primary

MeasureTime frameDescription
VAS pain scalefrom start to the end of the procedureVAS pain scale

Contacts

Primary ContactLuca Boeri, MD
luca.boeri@policlinico.mi.it+393663142529

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026