The Influence of Music on perceiVed paIn and leVels of Anxiety whiLe unDergoing transperIneal Prostate Biopsy: the VIVALDI Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Music intervention.
- Who it may be relevant to
- Registry conditions: Prostate Cancer, Pain Management. Basic parameters: from 50 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Other Music intervention
music during the biopsy
Primary outcome measures
- VAS pain scale [Time frame: from start to the end of the procedure]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 14550444
Identifiers
NCT: NCT07234097 · VIVALDI