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

Chang Bing Show Chwan Memorial Hospital

Status: Unknown

Conditions: Dementia

Treatments: Other: White noise

Study type: Interventional

Funder types: Other

Identifiers

NCT02271321

1021001

Details and patient eligibility

About

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

Full 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.

Enrollment: 84 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

84 participants in 2 patient groups

control group

No Intervention group

Description:

The control group will receive usual care

experimental group

Experimental group

Description:

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.

Treatment:

Other: White noise