PainNCT07692893
The BARBER Trial: Music and Binaural Beats During Prostate Biopsy
A study testing Binaural beats auditory intervention, Classical music auditory intervention and No Music Group in people with Pain and Anxiety, run by University of Trieste at 1 site in Italy.
Trial 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?… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Pain, Anxiety, Prostate Biopsy
- What is being tested?
- Binaural beats auditory intervention, Classical music auditory intervention and No Music Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Urology, Azienda Sanitaria Universitaria Giuliano Isontina
Trieste, TS, 34100
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Conditions
- Pain, Anxiety, Prostate Biopsy
- Being tested
- Binaural beats auditory intervention, Classical music auditory intervention, No Music Group
- Keywords
- Prostate biopsy; Anxiety; Pain; Binaural beats; Classical music; Music intervention; Randomized trial
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Binaural beats auditory interventionBehavioural
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 interventionBehavioural
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 GroupBehavioural
Participants underwent the prostate biopsy procedure without listening to music or binaural beats.
| Study group | Role | What they receive |
|---|---|---|
| Binaural Beats Group | Experimental | Participants listened to Samuel Barber's Adagio for Strings embedded with a 6-Hz binaural beat during the prostate biopsy procedure. Receives: Behavioral: Binaural beats auditory intervention |
| Classical Music Group | Active comparator | Participants listened to Samuel Barber's Adagio for Strings without binaural beats during the prostate biopsy procedure. Receives: Behavioral: Classical music auditory intervention |
| No Music Group | Active comparator | Participants underwent the prostate biopsy procedure without listening to music or binaural beats. Receives: Behavioral: No Music Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 15 minutes after prostate biopsy
Secondary outcomes (1)
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.
Measured: 15 minutes after prostate biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start1 Jan 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized in a 1:1:1 ratio to one of three parallel groups: classical music, classical music embedded with binaural beats, or no music. Each participant received only the assigned intervention during the prostate biopsy procedure.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Trieste
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesca Vedovo, University of Trieste
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07692893
- Sponsor's protocol ID
- BARBER-136-2023
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared because no specific consent for public data sharing was obtained from participants.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Classical Music and Binaural Beats During Prostate Biopsy: The BARBER Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07692893
- Acronym / sponsor ID
- BARBER-136-2023
- Conditions
- Pain, Anxiety, Prostate Biopsy
- Keywords
- Prostate biopsy; Anxiety; Pain; Binaural beats; Classical music; Music intervention; Randomized trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- University of TriesteUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants were randomized in a 1:1:1 ratio to one of three parallel groups: classical music, classical music embedded with binaural beats, or no music. Each participant received only the assigned intervention during the prostate biopsy procedure.
| Arm | Type | Receives |
|---|---|---|
| Binaural Beats Group | Experimental | Behavioral: Binaural beats auditory interventionParticipants listened to Samuel Barber's Adagio for Strings embedded with a 6-Hz binaural beat during the prostate biopsy procedure. |
| Classical Music Group | Active comparator | Behavioral: Classical music auditory interventionParticipants listened to Samuel Barber's Adagio for Strings without binaural beats during the prostate biopsy procedure. |
| No Music Group | Active comparator | Behavioral: No Music GroupParticipants underwent the prostate biopsy procedure without listening to music or binaural beats. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Binaural beats auditory interventionParticipants 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. | Behavioural | Binaural Beats Group |
| Classical music auditory interventionParticipants 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. | Behavioural | Classical Music Group |
| No Music GroupParticipants underwent the prostate biopsy procedure without listening to music or binaural beats. | Behavioural | No Music Group |
Primary outcome
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.
1 secondary outcome
Pain Score After Prostate Biopsy
Time frame: 15 minutes after prostate biopsy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared because no specific consent for public data sharing was obtained from participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Binaural beats auditory intervention, Classical music auditory intervention and No Music Group in people with Pain and Anxiety, run by University of Trieste at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in State Anxiety Score (time frame: Baseline and 15 minutes after prostate biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.