Clinical trial NCT02271321: The Effects of White Noise on Agitated Behaviors and Cortisol Level in Saliva Among the Patients With Dementia
Official title: The Effects of White Noise on Agitated Behaviors and Cortisol in Saliva Among the Patients With Dementia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dementia
Keywords: dementia
white noise
agitation
saliva cortisol
Lead sponsor: Chang Bing Show Chwan Memorial Hospital
Sponsor class: OTHER
First posted: 2014-10-22
Enrollment: 84
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Improve the agitation behavior
timeFrame: Change from baseline in agitation behavior at 1 months
Secondary outcomes:
measure: Improve the cortisol homeostasis
timeFrame: Change from baseline in saliva cortisol at 1 months
measure: Improve quality of care
timeFrame: Change from baseline in quality of care at 1 months
measure: Basic attribute data
timeFrame: Baseline
Other outcomes:
Locations:
city: Changhua County
country: Taiwan
facility: Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital
Study officials:
affiliation: Department of Nursing, Hung Kuang University
name: Li-Wei Lin, PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang Bing Show Chwan Memorial Hospital & Central Taiwan University of Science and Technology
name: Shu-Hui Yeh, PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kuang Tien General Hospital
name: Li-Jane Tsai, M.S.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang Bing Show Chwan Memorial Hospital
name: Lu-Jen Tsai, M.S.
role: PRINCIPAL_INVESTIGATOR
References: