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

NCT ID: NCT02271321

Last Updated: 2014-10-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-11-30

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.

Conditions

Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

control group

The control group will receive usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

experimental group

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.

Group Type: EXPERIMENTAL

White noise

Intervention Type: OTHER

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.

Interventions

White 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.

Intervention Type: OTHER

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

-

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Bing Show Chwan Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shu-Hui Yeh

RN, PhD, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Li-Wei Lin, PhD.

Role: PRINCIPAL_INVESTIGATOR

Department of Nursing, Hung Kuang University

Shu-Hui Yeh, PhD.

Role: PRINCIPAL_INVESTIGATOR

Chang Bing Show Chwan Memorial Hospital & Central Taiwan University of Science and Technology

Li-Jane Tsai, M.S.

Role: PRINCIPAL_INVESTIGATOR

Kuang Tien General Hospital

Lu-Jen Tsai, M.S.

Role: PRINCIPAL_INVESTIGATOR

Chang Bing Show Chwan Memorial Hospital

Locations

Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital

Changhua County, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Shu-Hui Yeh, PhD.

Role: CONTACT

yehshuhui@gmail.com

Kuender D. Yang, PhD.

Role: CONTACT

yangkd.yeh@hotmail.com

886-975617006

Facility Contacts

Shu-Hui Yeh, PhD

Role: primary

yehshuhui@gmail.com

Other Identifiers

1021001

Identifier Type: -

Identifier Source: org_study_id