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

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ClinicalTrials.gov Identifier: NCT02271321
Recruitment Status : Unknown
Verified October 2014 by Shu-Hui Yeh, Chang Bing Show Chwan Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : October 22, 2014
Last Update Posted : October 22, 2014
Sponsor:
Information provided by (Responsible Party):
Shu-Hui Yeh, Chang Bing Show Chwan Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Dementia Other: White noise Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: The Effects of White Noise on Agitated Behaviors and Cortisol in Saliva Among the Patients With Dementia
Study Start Date : November 2013
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : November 2015


Arm Intervention/treatment
No Intervention: control group
The control group will receive usual care
Experimental: 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.
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.



Primary Outcome Measures :
  1. Improve the agitation behavior [ Time Frame: Change from baseline in agitation behavior at 1 months ]
    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.


Secondary Outcome Measures :
  1. Improve the cortisol homeostasis [ Time Frame: Change from baseline in saliva cortisol at 1 months ]
    Cortisol concentrations will be measured at two different times: (1)baseline data: before white noise intervention, (2) outcome data: at four weeks post-test.

  2. Improve quality of care [ Time Frame: Change from baseline in quality of care at 1 months ]
    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.

  3. Basic attribute data [ Time Frame: Baseline ]
    Barthel Index, amount of activity, date in nursing home and medication situation.



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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02271321


Contacts
Contact: Shu-Hui Yeh, PhD. yehshuhui@gmail.com
Contact: Kuender D. Yang, PhD. 886-975617006 yangkd.yeh@hotmail.com

Locations
Taiwan
Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital Recruiting
Changhua County, Taiwan
Contact: Shu-Hui Yeh, PhD       yehshuhui@gmail.com   
Sponsors and Collaborators
Chang Bing Show Chwan Memorial Hospital
Investigators
Principal Investigator: Li-Wei Lin, PhD. Department of Nursing, Hung Kuang University
Principal Investigator: Shu-Hui Yeh, PhD. Chang Bing Show Chwan Memorial Hospital & Central Taiwan University of Science and Technology
Principal Investigator: Li-Jane Tsai, M.S. Kuang Tien General Hospital
Principal Investigator: Lu-Jen Tsai, M.S. Chang Bing Show Chwan Memorial Hospital

Responsible Party: Shu-Hui Yeh, RN, PhD, Professor, Chang Bing Show Chwan Memorial Hospital
ClinicalTrials.gov Identifier: NCT02271321     History of Changes
Other Study ID Numbers: 1021001
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: October 22, 2014
Last Verified: October 2014

Keywords provided by Shu-Hui Yeh, Chang Bing Show Chwan Memorial Hospital:
dementia
white noise
agitation
saliva cortisol

Additional relevant MeSH terms:
Dementia
Psychomotor Agitation
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hydrocortisone
Anti-Inflammatory Agents