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Completed

NCT Number: NCT07692893

The BARBER Trial: Music and Binaural Beats During Prostate Biopsy

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.

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Key information

Conditions

Pain Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Prostate Biopsy Signs and Symptoms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Urology, Azienda Sanitaria Universitaria Giuliano Isontina

Trieste, TS, 34100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Binaural beats auditory intervention

Behavioral

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.

Classical music auditory intervention

Behavioral

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.

No Music Group

Behavioral

Participants underwent the prostate biopsy procedure without listening to music or binaural beats.

Primary outcomes

  1. Change in State Anxiety Score

    Time frame: Baseline and 15 minutes after prostate biopsy

    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.

Secondary outcomes

  1. Pain Score After Prostate Biopsy

    Time frame: 15 minutes 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.

Sponsors and collaborators

Lead sponsor

University of Trieste

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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