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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02271321
Enrollment
84
Registered
2014-10-22
Start date
2013-11-30
Completion date
2015-11-30
Last updated
2014-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia

Keywords

dementia, white noise, agitation, saliva cortisol

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.

Interventions

OTHERWhite noise

White noise is a simple, convenient, non-invasive and effective intervention. it sounds like the sound of running water, ocean or fan operation sounds. In this study, Subjects 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.

Sponsors

Chang Bing Show Chwan Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

\-

Design outcomes

Primary

MeasureTime frameDescription
Improve the agitation behaviorChange from baseline in agitation behavior at 1 monthsAgitation 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.

Secondary

MeasureTime frameDescription
Improve the cortisol homeostasisChange from baseline in saliva cortisol at 1 monthsCortisol concentrations will be measured at two different times: (1)baseline data: before white noise intervention, (2) outcome data: at four weeks post-test.
Improve quality of careChange from baseline in quality of care at 1 monthsQuality of care will be assessed by ease-of-care inventory at at two different times: (1) baseline data :before white noise intervention, (2) outcome data: at four weeks post-test.
Basic attribute dataBaselineBarthel Index, amount of activity, date in nursing home and medication situation.

Countries

Taiwan

Contacts

Primary ContactShu-Hui Yeh, PhD.
yehshuhui@gmail.com
Backup ContactKuender D. Yang, PhD.
yangkd.yeh@hotmail.com886-975617006

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026