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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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TS
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Trieste, TS, Italien, 34100
- Department of Urology, Azienda Sanitaria Universitaria Giuliano Isontina
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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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Aktiver Komparator: 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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Aktiver Komparator: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in State Anxiety Score
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Pain Score After Prostate Biopsy
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- BARBER-136-2023
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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