The BARBER Trial: Music and Binaural Beats During Prostate Biopsy
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:
- 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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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TS
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Trieste, TS, Italia, 34100
- Department of Urology, Azienda Sanitaria Universitaria Giuliano Isontina
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Binaural Beats Group
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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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.
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Comparatore attivo: Classical Music Group
Participants listened to Samuel Barber's Adagio for Strings without binaural beats during the prostate biopsy procedure.
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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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Comparatore attivo: No Music Group
Participants underwent the prostate biopsy procedure without listening to music or binaural beats.
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Participants underwent the prostate biopsy procedure without listening to music or binaural beats.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Change in State Anxiety Score
Lasso di tempo: Baseline and 15 minutes after prostate biopsy
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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.
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Baseline and 15 minutes after prostate biopsy
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Pain Score After Prostate Biopsy
Lasso di tempo: 15 minutes after prostate biopsy
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Pain intensity after prostate biopsy, assessed using a visual analog scale ranging from 0 to 10, where higher scores indicate greater pain.
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15 minutes after prostate biopsy
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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- BARBER-136-2023
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
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