Elderly Demented Patients: Aromatherapy Complementary to Psychopharmacotherapy Psychological Disorders and BPSD Behavior

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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BPSD (Behavioral and Psycological Symptoms of Dementia)

Intervention / Treatment
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* Other: essential oils


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: GROUP A - control group<br>16 patients who respect the inclusion criteria, treated with psychotropic drugs Pro Re Nata. | |
| Experimental: GROUP B - aromatherapy group<br>16 patients included in the inclusion criteria, treated with psychotropic drugs Pro Re Nata and, in a complementary way, with diffusion aromatherapy | Other: essential oils<br>* 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<br>* Other names: wild orange essential oil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Role of Essential Oil Therapy in Environmental Diffusion as a Complement of Psychotropic Drugs in the Management of Psychological and Behavioral Disorders (BPSD) | The Neuropsychiatric Inventory - Nursing Home Version (NPI-NH) test will characterize the neuropsychiatric and psychopathological symptoms of patients affected by dementia. Events as delirium, anxiety, depression, etc. will be recorded by the frequency (from 0, absence, to 4, high frequency) and the seriousness (from 0, absence, to 3, high). The total score of the NPI-NH is given by the frequency x (multiply) seriousness (total score for each event has a range from 0 to 12). The patient final score will be given by the sum of the score of the 12 events. For each patient will be given a total score from 0 to 144. NPI NH score has been collected in both control and aromatherapy groups at T1 and T3, in patients who needed and who did not needed Pro Re Nata. | Time 1 (baseline) and Time 3 (day 7) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Role of Essential Oil Therapy in Environmental Diffusion in Professional Caregiver Distress Linked to BPSD | NPI-NH assess the psychological distress in physicians, nurses and nursing assistants who managed the patients. It has a score from 0 (no discomfort) to score of 5 (extreme discomfort). The psychological distress is measured for each of the 12 events in the NPI-NH scale, for a total score from 0 to 60. | Time 1 (baseline) and Time 3 (day 7) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BPSD (behavioral and psycological symptoms of dementia), aromatherapy, elderly