BPSD (Behavioral and Psycological Symptoms of Dementia) Clinical Trial
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
| NCT number | NCT03662360 |
| Other study ID # | CLM_ds_p_02 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 20, 2018 |
| Est. completion date | July 30, 2018 |
| Verified date | September 2021 |
| Source | Clinica Luganese Moncucco |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 32 |
| Est. completion date | July 30, 2018 |
| Est. primary completion date | June 30, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 70 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Clinica Luganese Moncucco | Lugano | Ticino |
| Lead Sponsor | Collaborator |
|---|---|
| Clinica Luganese Moncucco |
Switzerland,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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) |