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
|Condition or disease||Intervention/treatment||Phase|
|Dementia||Other: White noise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||84 participants|
|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|
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.
- 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.
- 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.
- 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.
- Basic attribute data [ Time Frame: Baseline ]Barthel Index, amount of activity, date in nursing home and medication situation.
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
|Contact: Shu-Hui Yeh, PhD.||email@example.com|
|Contact: Kuender D. Yang, PhD.||firstname.lastname@example.org|
|Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital||Recruiting|
|Changhua County, Taiwan|
|Contact: Shu-Hui Yeh, PhD email@example.com|
|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|