Elderly Demented Patients: Aromatherapy Complementary to Psychopharmacotherapy Psychological Disorders and BPSD Behavior
NCT ID: NCT03662360
Last Updated: 2021-09-30
Study Results
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View full resultsBasic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2018-05-20
2018-07-30
Brief Summary
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Detailed Description
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In absence of the universally recognized guidelines, the standard treatment involves the use of psychotropic drugs (typical / atypical neuroleptics, antidepressants, benzodiazepines) that are often not very effective and involve a series of side effects such as sedation, slowing down -motor with impaired cognitive performance, cardiac electrical changes and extrapyramidal syndrome. In view of this, it is important to find an alternative methods of treatment, which can reduce psychological and behavioral disorders and at the same time the use of psychotropic drugs.
As for aromatherapy, ie the therapeutic use of natural essential oils, there is a decades-long clinical experience, especially in France, which is accompanied by increasing scientific evidence with considerable increase in publications in its use in psychological disorders and dementia behavior related. Based on the scientific publications available, it was therefore decided to use two essential oils (Citrus sinensis, Lavandula angustifolia) in environmental diffusion in the Geriatric Department of the Clinica Luganese Moncucco.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
A repetition of the first 4 blocks will be perform up to 32 patients:
AABB, ABAB, BBAA, BABA AABB, ABAB, BBAA, BABA
TREATMENT
NONE
Study Groups
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GROUP A - control group
16 patients who respect the inclusion criteria, treated with psychotropic drugs Pro Re Nata.
No interventions assigned to this group
GROUP B - aromatherapy group
16 patients included in the inclusion criteria, treated with psychotropic drugs Pro Re Nata and, in a complementary way, with diffusion aromatherapy
essential oils
Following a specific schema, the randomization will be perfomed. Patients enrolled in Group B will receive in environmental diffusion two essential oils, to define their possible effectiveness in the control of the psychological and behavioural disorders
Interventions
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essential oils
Following a specific schema, the randomization will be perfomed. Patients enrolled in Group B will receive in environmental diffusion two essential oils, to define their possible effectiveness in the control of the psychological and behavioural disorders
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* patients with a known diagnosis of dementia associated with BPSD or diagnosis performed during hospitalization.
Exclusion Criteria
* patients with Mild Cognitive Impairment (MCI) - section 4 -;
* patients with language barrier;
* patients already being treated with aromatherapy.
70 Years
ALL
No
Sponsors
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Clinica Luganese Moncucco
OTHER
Responsible Party
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Pio Eugenio Fontana
Head of Geriatric Division
Principal Investigators
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Alessandra Franzetti Pellanda, MD
Role: STUDY_DIRECTOR
Clinica Luganese Moncucco
Pio Eugenio Fontana, MD
Role: STUDY_DIRECTOR
Clinica Luganese Moncucco
Locations
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Clinica Luganese Moncucco
Lugano, Canton Ticino, Switzerland
Countries
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References
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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CLM_ds_p_02
Identifier Type: -
Identifier Source: org_study_id
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