CClinicalTrials.gg
CompletedNCT07234097VIVALDIUpdated Oct 6, 2026

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

An interventional study of Music intervention in Prostate Cancer and Pain Management, sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. Completed at 1 site in Italy. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Not applicable, Interventional, and Other

Updated Oct 6, 2026Now CompletedFirst site in Italy+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
50 Years and older
Sex
Male
01

Study 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.

02

Conditions studied

  • Prostate Cancer
  • Pain Management

Keywords

  • pain management
  • prostate biopsy
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 78 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico is the lead sponsor of 214 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
Male
Accepts 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

Exclusion Criteria:

  • patients who have had prostate biopsies in the past
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
78 participants (actual)

Study arms

  • Experimental
    Music

    Group submitted to prostate biopsy with music

    Other: Music intervention

  • No intervention
    No music

    Group submitted to prostate biopsy without music

Interventions

  • OtherMusic intervention

    music during the biopsy

06

What researchers measure

Primary outcomes

  1. VAS pain scale

    VAS pain scale

    Time frame: from start to the end of the procedure

07

Study locations

1 site
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
    Milan, Italy
08

References and documents

Publications

  • Chang YH, Oh TH, Lee JW, Park SC, Seo IY, Jeong HJ, Kwon WA. Listening to music during transrectal ultrasound-guided prostate biopsy decreases anxiety, pain and dissatisfaction in patients: a pilot randomized controlled trial. Urol Int. 2015;94(3):337-41. doi: 10.1159/000368420. Epub 2014 Dec 18. PubMed 25531837 ↗
  • Dell'Atti L. Impact of music on anxiety and pain perception among men undergoing prostate biopsy: Synthesis of qualitative literature. Complement Ther Clin Pract. 2021 May;43:101330. doi: 10.1016/j.ctcp.2021.101330. Epub 2021 Feb 6. PubMed 33578321 ↗
  • Kyriakides R, Jones P, Geraghty R, Skolarikos A, Liatsikos E, Traxer O, Pietropaolo A, Somani BK. Effect of Music on Outpatient Urological Procedures: A Systematic Review and Meta-Analysis from the European Association of Urology Section of Uro-Technology. J Urol. 2018 May;199(5):1319-1327. doi: 10.1016/j.juro.2017.11.117. Epub 2017 Dec 7. PubMed 29225059 ↗
  • Vanoli S, Grobet-Jeandin E, Windisch O, Valerio M, Benamran D. Evolution of anxiety management in prostate biopsy under local anesthesia: a narrative review. World J Urol. 2024 Jan 20;42(1):43. doi: 10.1007/s00345-023-04723-2. PubMed 38244150 ↗
  • Novella G, Ficarra V, Galfano A, Ballario R, Novara G, Cavalleri S, Artibani W. Pain assessment after original transperineal prostate biopsy using a coaxial needle. Urology. 2003 Oct;62(4):689-92. doi: 10.1016/s0090-4295(03)00483-7. PubMed 14550444 ↗

Individual participant data

Plan to share: Undecided

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Completed
changed Oct 6, 2026
Sites
1 site added — first site in Italy
Show site
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico · Milan, Italy
Oct 6, 2026
Show all 1 update
  1. Oct 6, 2026
    Not yet recruiting→Completed
    1 site added — first site in Italy
    Show site
    • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico · Milan, Italy
    + 3 other changes: date precision, responsible party and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07234097
Lead sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Responsible party
Luca Boeri (Principal Investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico) — Principal investigator
First posted
Nov 18, 2025
Start date
Dec 1, 2025
Primary completion
Mar 31, 2026
Completion
Apr 30, 2026
Last update
Oct 6, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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