Anxiety, Pain, Prostate Biopsy
Conditions
Keywords
Prostate biopsy; Anxiety; Pain; Binaural beats; Classical music; Music intervention; Randomized trial
Brief 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.
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.
Interventions
BEHAVIORALBinaural 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.
BEHAVIORALClassical 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.
BEHAVIORALNo Music Group
Participants underwent the prostate biopsy procedure without listening to music or binaural beats.
Sponsors
University of Trieste
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in State Anxiety Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain Score After Prostate Biopsy | 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. |
Countries
Italy
Outcome results
None listed