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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Not yet enrolling

Conditions: Pain Management; Prostate Cancer

Treatments: Other: Music intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07234097

VIVALDI

Details and patient eligibility

About

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.

Enrollment: 78 estimated patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 2 patient groups

Music

Experimental group

Description:

Group submitted to prostate biopsy with music

Treatment:

Other: Music intervention

No music

No Intervention group

Description:

Group submitted to prostate biopsy without music