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临床试验/NCT03047915
NCT03047915已完成不适用

The Effects of a Music Intervention on Older Adults in the Emergency Department

Columbia University1 个研究点 分布在 1 个国家目标入组 169 人开始时间: 2016年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
169
试验地点
1
主要终点
Mean Change in STAI Score

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Present to the ED
  • Aged 65 or over
  • Speak English or Spanish

排除标准

  • Individuals who are deaf
  • Prisoners
  • Individuals who cannot give informed consent

结局指标

主要结局

Mean Change in STAI Score

时间窗: 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.

次要结局

  • Mean Change in Blood Pressure (BP)(Baseline and 1 hour post-intervention)
  • Mean Change in Heart Rate (HR)(Baseline and 1 hour post-intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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