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The BARBER Trial: Music and Binaural Beats During Prostate Biopsy

3. juli 2026 opdateret af: Francesca Vedovo, University of Trieste

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

221

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Italien
    • TS
      • Trieste, TS, Italien, 34100
        • Department of Urology, Azienda Sanitaria Universitaria Giuliano Isontina

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Binaural Beats Group
Participants listened to Samuel Barber's Adagio for Strings embedded with a 6-Hz binaural beat during the prostate biopsy procedure.
Adfærdsmæssigt: Binaural 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.
Aktiv komparator: Classical Music Group
Participants listened to Samuel Barber's Adagio for Strings without binaural beats during the prostate biopsy procedure.
Adfærdsmæssigt: Classical 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.
Aktiv komparator: No Music Group
Participants underwent the prostate biopsy procedure without listening to music or binaural beats.
Adfærdsmæssigt: No Music Group
Participants underwent the prostate biopsy procedure without listening to music or binaural beats.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in State Anxiety Score
Tidsramme: 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.
Baseline and 15 minutes after prostate biopsy

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain Score After Prostate Biopsy
Tidsramme: 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.
15 minutes after prostate biopsy

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Trieste

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2024

Primær færdiggørelse (Faktiske)

30. juni 2025

Studieafslutning (Faktiske)

30. juni 2025

Datoer for studieregistrering

Først indsendt

3. juli 2026

Først indsendt, der opfyldte QC-kriterier

3. juli 2026

Først opslået (Faktiske)

9. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BARBER-136-2023

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be publicly shared because no specific consent for public data sharing was obtained from participants.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Smerte

Kliniske forsøg med Binaural beats auditory intervention

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Sponsorer og samarbejdspartnere

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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