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

NCT07234097 | Not Yet Recruiting

• 1 other identifier: VIVALDI
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prostate Cancer; Pain Management

Keywords

pain management; prostate biopsy

Outcome Measures

Primary Outcomes (1)

• VAS pain scale

  VAS pain scale

  from start to the end of the procedure

Study Arms (2)

Music

EXPERIMENTAL

Group submitted to prostate biopsy with music

Other: Music intervention

No music

NO INTERVENTION

Group submitted to prostate biopsy without music

Interventions

Music intervention OTHER

music during the biopsy

Music

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: male patients who need a prostate biopsy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• patients who have had prostate biopsies in the past

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Related Publications (5)

• 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.

  PMID: 25531837 BACKGROUND

• 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.

  PMID: 33578321 BACKGROUND

• 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.

  PMID: 29225059 BACKGROUND

• 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.

  PMID: 38244150 BACKGROUND

• 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.

  PMID: 14550444 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Agnosia

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Luca Boeri, MD

CONTACT

+393663142529; luca.boeri@policlinico.mi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: Randomized trial

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: December 1, 2025
• Primary Completion: March 31, 2026
• Study Completion: April 30, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11