The Influence of Music on perceiVed paIn and leVels of Anxiety whiLe unDergoing transperIneal Prostate Biopsy: the VIVALDI Trial
NCT ID: NCT07234097
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
78 participants
INTERVENTIONAL
2025-12-01
2026-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Music
Group submitted to prostate biopsy with music
Music intervention
music during the biopsy
No music
Group submitted to prostate biopsy without music
No interventions assigned to this group
Interventions
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Music intervention
music during the biopsy
Eligibility Criteria
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Inclusion Criteria
* Patients who have signed informed consent
* Age \> 50 years
* Male
Exclusion Criteria
50 Years
MALE
No
Sponsors
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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
OTHER
Responsible Party
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Luca Boeri
Dr
Central Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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VIVALDI
Identifier Type: -
Identifier Source: org_study_id
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