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Clinical Trials/NCT03662360
NCT03662360
Completed
N/A

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

Clinica Luganese Moncucco1 site in 1 country32 target enrollmentMay 20, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
BPSD (Behavioral and Psycological Symptoms of Dementia)
Sponsor
Clinica Luganese Moncucco
Enrollment
32
Locations
1
Primary Endpoint
Role of Essential Oil Therapy in Environmental Diffusion as a Complement of Psychotropic Drugs in the Management of Psychological and Behavioral Disorders (BPSD)
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 20, 2018
End Date
July 30, 2018
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Clinica Luganese Moncucco
Responsible Party
Principal Investigator
Principal Investigator

Pio Eugenio Fontana

Head of Geriatric Division

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.

Outcomes

Primary Outcomes

Role of Essential Oil Therapy in Environmental Diffusion as a Complement of Psychotropic Drugs in the Management of Psychological and Behavioral Disorders (BPSD)

Time Frame: Time 1 (baseline) and Time 3 (day 7)

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.

Secondary Outcomes

  • Role of Essential Oil Therapy in Environmental Diffusion in Professional Caregiver Distress Linked to BPSD(Time 1 (baseline) and Time 3 (day 7))

Study Sites (1)

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