Clinical trial NCT03662360: Elderly Demented Patients: Aromatherapy Complementary to Psychopharmacotherapy Psychological Disorders and BPSD Behavior
Official title: Elderly Patients With Dementia in the Department of Acute Geriatrics: Pilot Study, Monocentric, Randomized Use of Aromatherapy as a Complementary Treatment to Psychopharmacotherapy in Psychological Disorders and BPSD Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: BPSD (Behavioral and Psycological Symptoms of Dementia)
Keywords: BPSD (behavioral and psycological symptoms of dementia)
aromatherapy
elderly
Lead sponsor: Clinica Luganese Moncucco
Sponsor class: OTHER
First posted: 2018-09-07
Enrollment: 32
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The enrolled patients will be randomized following the 4 blocks random schema (AABB, ABAB, BBAA, BABA, ABBA, BAAB).

A repetition of the first 4 blocks will be perform up to 32 patients:

AABB, ABAB, BBAA, BABA AABB, ABAB, BBAA, BABA
Primary purpose: TREATMENT

Brief summary: Behavioral and psycological symptoms of dementia, (BPSD) are one of the major problem for families, doctors and for patients the same. To reduce the side effects of the standard treatments, is important to find an alternative methods of treatment, eg the aromatherapy. There is an incresing in scientific evidence the its use in dementia behavior related.

Detailed description: Behavioral and psycological symptoms of dementia, (BPSD) are one of the major problem for families, doctors and for patients the same.

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.

Eligibility criteria: Inclusion Criteria:

* patients admitted to the acute geriatric ward;
* patients with a known diagnosis of dementia associated with BPSD or diagnosis performed during hospitalization.

Exclusion Criteria:

* patients with alcohol-based dementia;
* patients with Mild Cognitive Impairment (MCI) - section 4 -;
* patients with language barrier;
* patients already being treated with aromatherapy.

Primary outcomes:
measure: Role of Essential Oil Therapy in Environmental Diffusion as a Complement of Psychotropic Drugs in the Management of Psychological and Behavioral Disorders (BPSD)
timeFrame: Time 1 (baseline) and Time 3 (day 7)
Secondary outcomes:
measure: Role of Essential Oil Therapy in Environmental Diffusion in Professional Caregiver Distress Linked to BPSD
timeFrame: Time 1 (baseline) and Time 3 (day 7)
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Clinica Luganese Moncucco
state: Ticino
Study officials:
affiliation: Clinica Luganese Moncucco
name: Alessandra Franzetti Pellanda, MD
role: STUDY_DIRECTOR
affiliation: Clinica Luganese Moncucco
name: Pio Eugenio Fontana, MD
role: STUDY_DIRECTOR
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