The BARBER Trial: Music and Binaural Beats During Prostate Biopsy (NCT07692893) | Clinical Trial Compass
CompletedNot Applicable
The BARBER Trial: Music and Binaural Beats During Prostate Biopsy
Italy221 participantsStarted 2024-01-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in State Anxiety Score
Timeframe: Baseline and 15 minutes after prostate biopsy