ACTRN12617001159347Completed未知
The effectiveness of topical essential oils for agitation in dementia: a cluster-randomised, placebo-controlled feasibility trial
niversity of South Australia Department of Rural Health0 sites38 target enrollmentStarted: August 8, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 38
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 40 Years to o limit (—)
- Sex
- All
Inclusion Criteria
- •(1) Has been a resident of the study site for a period of at least 4 weeks.
- •(2) Has a diagnosis of dementia (as determined by Mini-Mental State Examination (MMSE), DSM-IV criteria or medical diagnosis).
- •(3) Has clinically significant agitation (as defined by a score of 39 or greater on the CMAI, or a score of 4 or greater on the Pittsburgh Agitation Scale [PAS])
- •(4) Can provide informed consent, both directly (if appropriate) and via their next of kin.
Exclusion Criteria
- •(1) Concurrent exposure to essential oils in any form
- •(2) Concurrent exposure to other novel therapeutic interventions for agitation (e.g. Paro, Play up)
- •(3) History of significant head trauma or brain lesions
- •(4) Known allergy or sensitivity to any of the ingredients in the active or control interventions.
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