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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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TS
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Trieste, TS, 이탈리아, 34100
- Department of Urology, Azienda Sanitaria Universitaria Giuliano Isontina
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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활성 비교기: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in State Anxiety Score
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Pain Score After Prostate Biopsy
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- BARBER-136-2023
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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