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临床试验/NCT02271321
NCT02271321Unknown不适用

The Effects of White Noise on Agitated Behaviors and Cortisol in Saliva Among the Patients With Dementia

Chang Bing Show Chwan Memorial Hospital1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2013年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
84
试验地点
1
主要终点
Improve the agitation behavior

研究概览

简要总结

The purpose of this study will be to examine the effects of white noise on agitation and saliva cortisol in elderly with dementia.

详细描述

Aging society is a global trend. In general, each additional five years for older than 65 years old, doubling the prevalence of dementia, that means is constantly increasing in dementia patients. Dementia elderly often appear negative emotion, memory disorders, sleep disorder and agitated behavior. With the progression of dementia, many patients present "sundown syndrome", which particularly appear agitation, hallucinations, delusions in the evening or at night and even accompanied by delirium and confusion. When the patient increased nocturnal awakenings, and even lead to roam at night and confusion, resulting in stress for families and carers. Therefore, the purpose of this study will to examine the effects of white noise on agitation and saliva cortisol in elderly with dementia. The sample sizes was calculated (Power: 0.8, α level: 0.05, effect size: 0.5) by G-Power statistical software. The estimated number of samples will be 35 cases for each group and the loss following rate of 20% will be considered and then each group will recruite 42 cases. In total, 84 cases will be recruited to participate the study. Four dementia care centers located in central and southern Taiwan will be selected and were randomly assigned to the experimental group (two centers) and the control group (two centers). The experimental group will receive 20 minute white noise of the ocean and the sound of running water at 16:00 to 17:00 for four weeks periods. The control group will receive usual care. Before the intervention and pretest, participants will be collected three days of saliva cortisol and observed agitation behavior for 10 days. After the four weeks of white noise intervention, post-test questionnaire, agitation behavior and saliva cortisol will be collected. The information collected will be entered into the computer SPSS 20.0 software for statistical analysis. White noise is a simple, convenient, non-invasive and effective intervention that hopes to improve the agitation behavior and saliva cortisol levels and improve quality of care for dementia elderly.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Outcomes Assessor)

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

  • 65 years and older
  • No hearing disorders
  • Able to communicate in Mandarin or Taiwanese
  • Able to attend the program and fill out inform consent.

排除标准

  • 未提供

研究组 & 干预措施

experimental group

Experimental

The experimental group will receive 20 minute white noise of the ocean and the sound of running water at 16:00 to 17:00 for four weeks periods.

干预措施: White noise (Other)

control group

No Intervention

The control group will receive usual care

结局指标

主要结局

Improve the agitation behavior

时间窗: Change from baseline in agitation behavior at 1 months

Agitation behavior will be assessed by Cohen-Mansfield Agitation Inventory (CMAI) including physically nonaggressive behavior (PNAB), physically aggressive behavior (PAGB), verbally nonaggressive behavior (VNAB) and verbally aggressive behavior (VAGB) at two different times: (1) baseline data :before white noise intervention, (2) outcome data: at four weeks post-test.

次要结局

  • Basic attribute data(Baseline)
  • Improve the cortisol homeostasis(Change from baseline in saliva cortisol at 1 months)
  • Improve quality of care(Change from baseline in quality of care at 1 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shu-Hui Yeh

RN, PhD, Professor

Chang Bing Show Chwan Memorial Hospital

研究点 (1)

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