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Speech Intelligibility and Cognition: Are Inpatients Impaired by Noise?

2011年2月15日 更新者:Portland VA Medical Center

Study Objectives:

  • 1. To examine the extent to which noise typical of nursing units reduces speech intelligibility in acutely ill hospitalized patients
  • 2. To examine the extent to which noise typical of nursing units impairs recall in acutely ill hospitalized patients
  • 3. To quantify severity of reduced performance associated with age, familiarity with the healthcare setting, hearing and health status.

Plan:

One hundred and twenty inpatients from the four medical/surgical nursing units at the Portland VA Medical Center, 60 with normal hearing and 60 with hearing impairment will be recruited to participate in the study. Following assessment to ascertain eligibility and obtaining informed consent, patients will be tested in a sound booth housed at the National Center for Rehabilitative Auditory Research (NCRAR). Designed so that each patient serves as his or her own control, we can accommodate considerable baseline variability between patients without adversely affecting required sample size. Patients' performance in speech intelligibility and recall tests will be measured using a constant level of speech, in controlled environments of no noise (baseline), white noise, hospital noise and hospital noise with speech, all delivered via headphones in pseudo-random order. Performance will be measured in each type of noise at decibel levels equivalent to those currently experienced on nursing units and at lower levels that prior studies have shown are more conducive to effective communication

By selecting measures that are particularly relevant to the safe care of hospitalized patients, and that have been studied extensively in healthy populations in highly controlled conditions, we expect to find compelling and unambiguous evidence that hospitalized patients correctly hear and recall very little of what is said to them during their hospitalizations. The majority of hospitalized patients stay on acute care nursing units during most or all of their hospitalizations, making this an appropriate population to study in the context of their responses to the noises typical in these environments. Perhaps most importantly, this study will heighten awareness of health-care personnel to the levels of impairment suffered by their patients - both in their ability to correctly interpret speech and to recall it - in the typical noisy environments of nursing units.

研究概览

研究类型

介入性

注册 (实际的)

84

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

    • Oregon
      • Portland、Oregon、美国、97239
        • Portland VA 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

18年 至 88年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion criteria:

  • Adult inpatients on medical/surgical nursing units at the Portland VA, greater than 18 years of age will be eligible to participate.

Exclusion criteria for 60 participants with hearing impairment:

  • Cognitively or physically unable to participate (reported by patient or nurse); electronic chart notes indicate patient exhibits aggressive behavior, documented dementia, Alzheimer's disease, or severe psychosocial disorder, patient undergoing detoxification, individual is not legally capable of independently providing informed consent
  • Patients who are not native American English speakers.
  • Patients who exhibit Meniere's disease or retrocochlear disorder based on patient report or notes in patient's chart.
  • Patient exhibits active or recent history of middle ear disorder based on otoscopy, tympanometry, immittance or notes in patient chart; 5) patients unwilling to participate.

Exclusion criteria for the other 60 participants:

  • Cognitively or physically unable to participate (reported by patient or nurse); electronic chart notes indicate patient exhibits aggressive behavior, documented dementia, Alzheimer's disease, or severe psychosocial disorder, patient undergoing detoxification, individual is not legally capable of independently providing informed consent
  • Patients who are not native American English speakers.
  • Patients who exhibit Meniere's disease or retrocochlear disorder based on patient report or notes in patient's chart.
  • Patient exhibits active or recent history of middle ear disorder based on otoscopy, tympanometry, immittance or notes in patient chart.
  • Patients with hearing loss that exceeds 25 dBHL in any frequency between .l5 and 3 kHz.
  • Patients unwilling to participate.

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:卫生服务研究
  • 分配:非随机化
  • 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
其他:1
hearing impaired inpatients
no noise
noise without speech
noise with speech present
其他:2
Non-hearing-impaired inpatients
no noise
noise without speech
noise with speech present

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Change in the percent of correctly identified words at different signal-to-noise rations (levels +4, +8 and +12 db) above that of the two types of noise, relative to the percent identified in quiet
大体时间:immediately after presentation
immediately after presentation

次要结果测量

结果测量
大体时间
Change in the percent of correctly recalled words at different signal-to-noise rations (levels +4, +8 and +12 db) above that of the two types of noise, relative to the percent recalled in quiet
大体时间:five minutes after presentation
five minutes after presentation

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:Diana S Pope, PhD, MS, RN、Portland VA Medical Center

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

2010年1月1日

初级完成 (实际的)

2010年12月1日

研究完成 (实际的)

2010年12月1日

研究注册日期

首次提交

2008年6月9日

首先提交符合 QC 标准的

2008年6月9日

首次发布 (估计)

2008年6月11日

研究记录更新

最后更新发布 (估计)

2011年2月16日

上次提交的符合 QC 标准的更新

2011年2月15日

最后验证

2011年2月1日

更多信息

与本研究相关的术语

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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