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

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02271321
• Other study ID #: 1021001
• Status: Recruiting
• Phase: N/A
• First received: October 15, 2014
• Last updated: October 21, 2014
• Start date: November 2013
• Est. completion date: November 2015

Study information

• Verified date: October 2014
• Source: Chang Bing Show Chwan Memorial Hospital
• Contact: Shu-Hui Yeh, PhD.
• Email: yehshuhui[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Dementia
• Psychomotor Agitation

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Taiwan	Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital	Changhua County

Sponsors (1)

Lead Sponsor	Collaborator
Chang Bing Show Chwan Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improve the agitation behavior	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.	Change from baseline in agitation behavior at 1 months	No
Secondary	Improve the cortisol homeostasis	Cortisol concentrations will be measured at two different times: (1)baseline data: before white noise intervention, (2) outcome data: at four weeks post-test.	Change from baseline in saliva cortisol at 1 months	No
Secondary	Improve quality of care	Quality 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.	Change from baseline in quality of care at 1 months	No
Secondary	Basic attribute data	Barthel Index, amount of activity, date in nursing home and medication situation.	Baseline	No