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Music in the Emergency Department (ED)

2021年6月9日 更新者:Columbia University

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

地位

完全的

条件

干预/治疗

详细说明

A visit to the emergency department (ED) is anxiety provoking for patients by nature. Contributing factors may include the sudden timing of the visit, a noisy environment, and waiting in anticipation of a serious diagnosis or bad news. Studies suggest that nearly 75% of adult ED patients may experience mild to severe anxiety in relation to the ED visit, but not directly related to their chief complaint. Anxiety can have deleterious effects on a patient in the clinical setting. Patients may report excessive pain complaints and manifest the typical signs and symptoms of anxiety (e.g. anorexia, dry mouth, nausea, chest pain), which can complicate diagnosis. Patient anxiety can also impose barriers to communication with ED staff, hindering successful delivery of important medical information. A visit to the ED may be particularly distressing for older adults (age 65+), for they are more likely than younger adults to have a greater ED length of stay before discharge home, receive more diagnostic tests and venipuncture for intravenous (IV) access, and have poorer pain care. Music listening as an anxiolytic has been shown to be effective across a variety of clinical settings, however there is a relative paucity of published data on the use of music listening for adult patients in the ED. No published studies, to the investigators' knowledge, have evaluated the effect of music listening on older adults in the ED.

研究类型

介入性

注册 (实际的)

169

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • New York
      • New York、New York、美国、10032
        • Columbia University Irving Medical Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

65年 及以上 (年长者)

接受健康志愿者

有资格学习的性别

全部

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
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.
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.
The intervention consists of listening to a choice of music for 30 to 60 minutes on a loaned iPad with disposable headphones.

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
Mean Change in STAI Score
大体时间:Baseline and 1 hour post-intervention
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.
Baseline and 1 hour post-intervention

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
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.
Baseline and 1 hour post-intervention
Mean Change in Blood Pressure (BP)
大体时间:Baseline and 1 hour post-intervention
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.
Baseline and 1 hour post-intervention

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Ellen D. Sano, DO、Columbia University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2016年6月1日

初级完成 (实际的)

2017年10月1日

研究完成 (实际的)

2020年10月30日

研究注册日期

首次提交

2016年12月2日

首先提交符合 QC 标准的

2017年2月8日

首次发布 (估计)

2017年2月9日

研究记录更新

最后更新发布 (实际的)

2021年6月11日

上次提交的符合 QC 标准的更新

2021年6月9日

最后验证

2021年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • AAAQ3016

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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.

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