- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03047915
Music in the Emergency Department (ED)
The Effects of a Music Intervention on Older Adults in the Emergency Department
This will be a randomized controlled study evaluating the effect of a music-listening intervention compared to standard care (control) during patient visit to the emergency department (ED). Randomization will be done with consecutive sealed envelopes.
Data collection will be prospective with administration of the State Trait Anxiety Inventory and collection of physiologic parameters (pain level, heart rate, blood pressure). Retrospective data will also be collected for covariate analysis (age, race/ethnicity, emergency severity index (ESI), pain medications administered during the ED visit, pain scores throughout ED visit, chief complaint, and ED discharge diagnosis).
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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New York
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New York, New York, 미국, 10032
- Columbia University Irving Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Present to the ED
- Aged 65 or over
- Speak English or Spanish
Exclusion Criteria:
- Individuals who are deaf
- Prisoners
- Individuals who cannot give informed consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: Control Group
All subjects enrolled will respond to questions assessing anxiety using the State Trait Anxiety Inventory (STAI), and pain using a 1-10 numerical score, and will have blood pressure and heart rate taken.
Subjects randomized to the control group will continue the ED visit as usual.
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실험적: Music Group
All subjects enrolled will respond to questions assessing anxiety using the State Trait Anxiety Inventory (STAI), and pain using a 1-10 numerical score, and will have blood pressure and heart rate taken.
Subjects who are randomized to receive a music-listening intervention will listen to a choice of music for 30 to 60 minutes on a loaned iPad with disposable headphones.
An hour after enrollment, participants will be asked the same questions assessing anxiety and pain, and will also have blood pressure and heart rate taken again.
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The intervention consists of listening to a choice of music for 30 to 60 minutes on a loaned iPad with disposable headphones.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Mean Change in STAI Score
기간: Baseline and 1 hour post-intervention
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The STAI is scored from least/no anxiety (20 points) to severe anxiety (80 points).
The mean change in STAI scores from before the intervention to after the intervention will be calculated by subtracting the first score from second score.
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Baseline and 1 hour post-intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Mean Change in Heart Rate (HR)
기간: Baseline and 1 hour post-intervention
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The HR of patients will be recorded before and immediately after the intervention (for control subjects, 1 hour after enrollment).
Difference in HR will be calculated by comparing pre to post and mean change calculated for each group.
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Baseline and 1 hour post-intervention
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Mean Change in Blood Pressure (BP)
기간: Baseline and 1 hour post-intervention
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The BPs of subjects will be collected before and after the intervention (for control group, 1 hour after enrollment).
Change in BP will be calculated per patient and the mean change calculated for each group.
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Baseline and 1 hour post-intervention
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공동 작업자 및 조사자
수사관
- 수석 연구원: Ellen D. Sano, DO, Columbia University
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
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