Delirium Treatment With Acupuncture in Internal Medicine Departments
NCT ID: NCT03398928
Last Updated: 2020-09-18
Study Results
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View full resultsBasic Information
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COMPLETED
NA
81 participants
INTERVENTIONAL
2018-01-14
2020-06-01
Brief Summary
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Detailed Description
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Patients aged 65 and older, hospitalized in the internal medicine departments of Bnai Zion Medical Center and diagnosed with delirium or subsyndromal delirium will be randomized to either true acupuncture with usual care, or usual care only. Daily treatments and outcomes' follow-up will be conducted up to one week from recruitment or until resolution of delirium or subsyndromal delirium for 48 hours. The primary outcome will be delirium resolution evaluated as time-to-first delirium remission (over 7 days) and the number of days spent delirium-free.Side effects will be monitored daily.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Acupuncture
Acupuncture for delirium treatment
Acupuncture
Acupuncture added to usual care
Standard care
Standard conventional delirium care at the discretion of the department medical staff
No interventions assigned to this group
Interventions
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Acupuncture
Acupuncture added to usual care
Eligibility Criteria
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Inclusion Criteria
* Aged over 65 years
* Delirium or subsyndromal delirium within the last 48 hours
Exclusion Criteria
* Encephalopathy explained by a cause other than delirium (acute stroke, alcohol, cirrhosis, etc.)
* History of severe dementia
* Communication barriers preventing delirium assessment
65 Years
ALL
No
Sponsors
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Bnai Zion Medical Center
OTHER_GOV
Responsible Party
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Principal Investigators
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Elad Schiff, M.D.
Role: PRINCIPAL_INVESTIGATOR
Bnai Zion Medical Center
Locations
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Bnai Zion Medical Center
Haifa, Golomb 47, Israel
Countries
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References
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Levy I, Gavrieli S, Hefer T, Attias S, Schiff A, Oliven R, Wisberg-Levi S, Hanchinsky R, Schiff E. Acupuncture Treatment of Delirium in Older Adults Hospitalized in Internal Medicine Departments: An Open-Label Pragmatic Randomized-Controlled Trial. J Geriatr Psychiatry Neurol. 2022 May;35(3):333-343. doi: 10.1177/0891988721996804. Epub 2021 Mar 9.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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0102-14-BNZ
Identifier Type: -
Identifier Source: org_study_id
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