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).
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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New York
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New York、New York、美国、10032
- Columbia University Irving Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预: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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实验性的: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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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Mean Change in STAI Score
大体时间: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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Mean Change in Heart Rate (HR)
大体时间: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)
大体时间: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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合作者和调查者
调查人员
- 首席研究员:Ellen D. Sano, DO、Columbia University
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Music的临床试验
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University of Alabama at BirminghamThe Craig H. Neilsen Foundation; Lakeshore Foundation完全的
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Fondation Oeuvre de la Croix Saint-Simon撤销
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Assistance Publique - Hôpitaux de Paris尚未招聘疼痛 | 疼痛,术后 | 焦虑 | 胸外科 | 疼痛,胸部 | 术后焦虑