The BARBER Trial: Music and Binaural Beats During Prostate Biopsy

Classical Music and Binaural Beats During Prostate Biopsy: The BARBER Randomized Controlled Trial

The goal of this clinical trial was to learn whether listening to classical music or binaural beats could reduce anxiety and pain in adult men undergoing prostate biopsy.

The main questions it aimed to answer were:

• Does listening to classical music reduce anxiety and pain during prostate biopsy compared with no music?
• Does listening to classical music with binaural beats reduce anxiety and pain during prostate biopsy compared with classical music alone or no music?

Researchers compared three groups of participants: one group listened to classical music, one group listened to the same music with binaural beats, and one group did not listen to music.

Participants were asked to complete anxiety questionnaires before and after the biopsy. They also rated their pain after the procedure, and blood pressure and heart rate were recorded before and after the biopsy.

Study Overview

• Status: Completed
• Conditions: Pain; Anxiety; Prostate Biopsy
• Intervention / Treatment: Behavioral: Binaural beats auditory intervention; Behavioral: Classical music auditory intervention; Behavioral: No Music Group

Detailed Description

Prostate biopsy is a common urological procedure that may be associated with anxiety, pain, and discomfort. Music listening and binaural beats have been proposed as low-risk, non-pharmacological strategies to improve patient comfort during medical procedures.

This study was designed to evaluate whether a standardized auditory intervention could reduce anxiety and pain in men undergoing prostate biopsy under local anesthesia. Eligible participants were randomly assigned to one of three groups: classical music, the same classical music track embedded with binaural beats, or no music. Anxiety was assessed before and after the procedure using the State-Trait Anxiety Inventory Form Y, while pain was assessed using a visual analog scale. Physiological parameters were also recorded before and after the procedure.

• Study Type: Interventional
• Enrollment (Actual): 221
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • TS
    • Trieste, TS, Italy, 34100
      • Department of Urology, Azienda Sanitaria Universitaria Giuliano Isontina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male patients aged 18 years or older
• Scheduled to undergo prostate biopsy
• Italian speaking
• At least formal schooling, defined as 1 to 8 years of education
• Able to understand the study procedures and provide written informed consent

Exclusion Criteria:

• Severe hearing loss requiring the use of a hearing aid
• History of epilepsy
• Psychiatric disorders
• History of chronic pelvic pain syndrome
• Chronic use of antidepressant and/or analgesic drugs
• Use of analgesic drugs within 24 hours before the procedure
• Previous prostate biopsy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Binaural Beats Group; Participants listened to Samuel Barber's Adagio for Strings embedded with a 6-Hz binaural beat during the prostate biopsy procedure.	Behavioral: Binaural beats auditory intervention; Participants listened to Samuel Barber's Adagio for Strings embedded with a 6-Hz binaural beat during the prostate biopsy procedure. The binaural beat was generated by presenting a 384-Hz tone to the right ear and a 378-Hz tone to the left ear. The audio track was delivered through wireless stereo headphones.
Active Comparator: Classical Music Group; Participants listened to Samuel Barber's Adagio for Strings without binaural beats during the prostate biopsy procedure.	Behavioral: Classical music auditory intervention; Participants listened to Samuel Barber's *Adagio for Strings* during the prostate biopsy procedure. The same musical track used in the binaural beats group was delivered without embedded binaural beats through wireless stereo headphones.
Active Comparator: No Music Group; Participants underwent the prostate biopsy procedure without listening to music or binaural beats.	Behavioral: No Music Group; Participants underwent the prostate biopsy procedure without listening to music or binaural beats.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in State Anxiety Score	Change in state anxiety score from baseline to after prostate biopsy, assessed using the State-Trait Anxiety Inventory Form Y-1. The change was compared between the study groups.	Baseline and 15 minutes after prostate biopsy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score After Prostate Biopsy	Pain intensity after prostate biopsy, assessed using a visual analog scale ranging from 0 to 10, where higher scores indicate greater pain.	15 minutes after prostate biopsy

Collaborators and Investigators

• Sponsor: University of Trieste

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: July 3, 2026
• First Submitted That Met QC Criteria: July 3, 2026
• First Posted (Actual): July 9, 2026

Study Record Updates

• Last Update Posted (Actual): July 9, 2026
• Last Update Submitted That Met QC Criteria: July 3, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Prostate biopsy; Anxiety; Pain; Binaural beats; Classical music; Music intervention; Randomized trial
• Additional Relevant MeSH Terms: Neurologic Manifestations; Mental Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Anxiety Disorders
• Other Study ID Numbers: BARBER-136-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be publicly shared because no specific consent for public data sharing was obtained from participants.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No