The Effects of White Noise on Agitated Behaviors and Cortisol Level in Saliva Among the Patients With Dementia
1 other identifier
interventional
84
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 15, 2014
CompletedFirst Posted
Study publicly available on registry
October 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedOctober 22, 2014
October 1, 2014
2 years
October 15, 2014
October 21, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
Improve the cortisol homeostasis
Change from baseline in saliva cortisol at 1 months
Improve quality of care
Change from baseline in quality of care at 1 months
Basic attribute data
Baseline
Study Arms (2)
control group
NO INTERVENTIONThe control group will receive usual care
experimental group
EXPERIMENTALThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- years and older
- No hearing disorders
- Able to communicate in Mandarin or Taiwanese
- Able to attend the program and fill out inform consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital
Changhua County, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- RN, PhD, Professor
Study Record Dates
First Submitted
October 15, 2014
First Posted
October 22, 2014
Study Start
November 1, 2013
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
October 22, 2014
Record last verified: 2014-10