수술 후 통증 및 불안 감소를 위한 양이박자
외래 총 무릎 및 총 고관절 치환술 후 조기 수술 후 통증에 대한 양이음 vs 선택 음악: 무작위 대조 시험
To deliver a 30-minute binaural beats audio intervention in PACU and collect pain and anxiety outcomes immediately following surgery, and 4 hours following surgery completion in adults undergoing ambulatory total knee arthroplasty and total hip arthroplasty (TKA and THA).
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Andrew R Moya, MD
- 전화번호: 1786-856-6463
- 이메일: arm577@miami.edu, doc.a.moya1@gmail.com
연구 장소
-
-
Florida
-
Miami, Florida, 미국, 33132
- 모병
- Univeristy of Miami Health System
-
수석 연구원:
- Victor H Hernandez, MD
-
연락하다:
- Andrew R Moya, MD
- 전화번호: 786-856-6463
- 이메일: arm577@miami.edu
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- American Society of Anesthesiologists Physical Status Classification System (ASA) 1-3
- Spinal anesthesia
- Patients receiving nerve-block in Post-Anesthesia Care Unit (PACU)
- Primary total hip or total knee arthroplasty
Exclusion Criteria:
- Moderate-severe hearing impairment or use of hearing aids
- History of significant tinnitus, active delirium, chronic high-dose opioid therapy (>60 MME/day baseline)
- Major psychiatric pathology
- General anesthesia
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Binaural Beats (BB)
Participants assigned to this arm will listen to a 30-minute binaural beats audio session at a comfortable volume through standardized over-ear headphones while in the post-anesthesia care unit (PACU). The audio will use a primary target frequency of 10 Hz (alpha range), created using soft sine-wave carriers in the 200-600 Hz range that generate a 10 Hz interaural difference (e.g., 400 Hz left ear / 410 Hz right ear). Volume will be set at a comfortable conversational level (~55-65 dBA) and may be adjusted by the participant. The session will begin within 15 minutes of PACU arrival. Participants may stop the audio at any time. |
30-minute binaural beats audio session targeting 400 and 410 hertz (Hz) alpha 400 hertz (Hz) in one ear 410 hertz (Hz) in other ear frequency delivered through standardized headphones in the PACU. |
|
활성 비교기: Music of Choice (MOC)
Participants in this arm will receive usual postoperative care in the post-anesthesia care unit (PACU) and may listen to music of their choice using standardized headphones. They will select their preferred music and listen for 30 minutes at a comfortable volume (~55-65 dBA), which they may adjust as needed. No binaural beat frequencies will be used. Music listening is optional and may be stopped at any time. |
Usual postoperative care in addition to patient-selected music using standardized headphones |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Pain Score Numeric Pain Rating Scale (NPRS)
기간: Baseline (pre-operative) to 4 hours post-operation.
|
Pain intensity will be measured using the Numeric Pain Rating Scale (NPRS), a validated 0-10 scale where 0 = no pain and 10 = worst imaginable pain. Change will be calculated as the difference between the pre-operative NPRS score and the NPRS score obtained 4 hours after surgery. Higher scores indicate greater pain intensity. |
Baseline (pre-operative) to 4 hours post-operation.
|
|
Change in Anxiety Score State-Trait Anxiety Inventory (STAI-S)
기간: Baseline (pre-operative) to 4 hours post-operation.
|
Anxiety will be measured using the State-Trait Anxiety Inventory - State Subscale (STAI-S). The STAI-S consists of 20 items scored from 1 to 4, producing a total score range of 20-80, with higher scores indicating greater state anxiety. Change will be calculated as the difference between the pre-operative STAI-S score and the STAI-S score obtained 4 hours after surgery. |
Baseline (pre-operative) to 4 hours post-operation.
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Total Opioid Consumption in the Post-Anesthesia Care Unit (PACU) (MME)
기간: From PACU arrival (time 0) until PACU discharge (typically 1-4 hours post-operation)
|
Total opioid use administered during the post-anesthesia care unit (PACU) stay will be recorded, including all intravenous and oral opioid medications. All doses will be converted to morphine milligram equivalents (MME) using standard Centers for Disease Control and Prevention (CDC) conversion factors. Unit of Measure: Morphine milligram equivalents (MME) |
From PACU arrival (time 0) until PACU discharge (typically 1-4 hours post-operation)
|
|
Postoperative Vital Signs Heart Rate
기간: Every 30 minutes from PACU arrival until PACU discharge (approximately 1-4 hours post-operation).
|
Heart rate (beats per minute) recorded at fixed 30-minute intervals during PACU recovery. Values will be abstracted from the electronic medical record. |
Every 30 minutes from PACU arrival until PACU discharge (approximately 1-4 hours post-operation).
|
|
Patient Satisfaction Score
기간: Measured once during the PACU stay, at the earliest feasible time point up to 4 hours post-operation
|
Patient satisfaction with the postoperative experience will be measured using a 5-point Likert scale, where 1 = very dissatisfied and 5 = very satisfied. Unit of Measure: Likert score (1-5) |
Measured once during the PACU stay, at the earliest feasible time point up to 4 hours post-operation
|
|
Postoperative Vital Signs Blood Pressure
기간: Every 30 minutes from PACU arrival until PACU discharge (approximately 1-4 hours post-operation).
|
Systolic and diastolic blood pressure (millimeters of mercury) recorded at fixed 30-minute intervals during PACU recovery. Values will be abstracted from the electronic medical record. |
Every 30 minutes from PACU arrival until PACU discharge (approximately 1-4 hours post-operation).
|
|
Postoperative Vital Signs Respiratory Rate
기간: Every 30 minutes from PACU arrival until PACU discharge (approximately 1-4 hours post-operation).
|
Respiratory rate (breaths per minute) recorded at fixed 30-minute intervals during PACU recovery. Values will be abstracted from the electronic medical record. |
Every 30 minutes from PACU arrival until PACU discharge (approximately 1-4 hours post-operation).
|
공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Victor H Hernandez, MD, MSc, University of Miami
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 20251389
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .