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

Study acronym: VIVALDI
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico to Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Show 4 more changesShow less
    • Completed without a posted recruiting period
    • Study sites: 0 to 1
    • Publications: details revised at 5 of 5 entries
    • Eligibility criteria expanded, about 5 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07234097
Lead Sponsor Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Conditions
(from sponsor)		 Prostate Cancer, Pain Management
Related terms Agnosia, Prostatic Neoplasms
Enrollment 78 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov