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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Classical Music Group | Active Comparator | Participants listened to Samuel Barber's Adagio for Strings without binaural beats during the prostate biopsy procedure. |
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| No Music Group | Active Comparator | Participants underwent the prostate biopsy procedure without listening to music or binaural beats. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology, Azienda Sanitaria Universitaria Giuliano Isontina | Trieste | TS | 34100 | Italy |
Individual participant data will not be publicly shared because no specific consent for public data sharing was obtained from participants.
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| ID | Term |
|---|---|
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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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.
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| 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. |
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| No Music Group | Behavioral | Participants underwent the prostate biopsy procedure without listening to music or binaural beats. |
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