An interventional study of essential oils in BPSD (Behavioral and Psycological Symptoms of Dementia), sponsored by Clinica Luganese Moncucco. Completed at 1 site in Switzerland. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2021-09-30.
Sponsored by Clinica Luganese Moncucco · Not applicable, Interventional, and Treatment
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.
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.
2,172 studies on the registry are indexed under Dementia; 541 are open to participants now.
This study's enrollment of 32 is below the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →Clinica Luganese Moncucco is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
16 patients who respect the inclusion criteria, treated with psychotropic drugs Pro Re Nata.
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
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
Also known as: lavander essential oil, wild orange essential oil
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 frame: Time 1 (baseline) and Time 3 (day 7)
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 frame: Time 1 (baseline) and Time 3 (day 7)
NPI NH\> or = 1 at T1 (NPI-NH score from 0 to 144, patients with a score from 1 to 144 have been enrolled)
| Milestone | GROUP A - Control Group | GROUP B - Aromatherapy Group |
|---|---|---|
| Started | 16 | 16 |
| Completed | 16 | 14 |
| Not completed | 0 | 2 |
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.
| score on a scale | GROUP A - Control Group | GROUP B - Aromatherapy Group |
|---|---|---|
| T1 NPI score in patients do not need Pro Re Nata | 21.81 (6 to 42) | 25.93 (9 to 60) |
| T3 NPI score in patients needed Pro Re Nata | 32.87 (18 to 51) | 16.5 (9 to 33) |
| T3 NPI score in patients do not need Pro Re Nata | 20.00 (5 to 42) | 7.25 (5 to 10) |
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.
| score on a scale | GROUP A - Control Group | GROUP B - Aromatherapy Group |
|---|---|---|
| T1 NPI NH physicians in pts with PRN | 4.19 (0 to 18) | 5.64 (0 to 15) |
| T1 NPI NH physicians in pts without PRN | 1.60 (0 to 9) | 4.13 (0 to 20) |
| T1 NPI NH nurses in pts with PRN | 9.63 (0 to 25) | 11.64 (0 to 21) |
| T1 NPI NH nurses in pts without PRN | 6.40 (0 to 14) | 10.13 (0 to 27) |
| T1 NPI NH nursing assistants in pts with PRN | 11.00 (0 to 27) | 12.21 (0 to 23) |
| T1 NPI NH nursing assistants in pts without PRN | 7.10 (0 to 15) | 10.88 (0 to 31) |
| T3 NPI NH physician in pts with PRN | 6.00 (0 to 21) | 2.64 (0 to 15) |
| T3 NPI NH physician in pts without PRN | 3.20 (0 to 12) | 0.88 (0 to 6) |
| T3 NPI NH nurses in pts with PRN | 12.00 (0 to 27) | 5.79 (0 to 19) |
| T3 NPI NH nurses in pts without PRN | 9.30 (0 to 19) | 4.25 (0 to 10) |
| T3 NPI NH nursing assistants in pts with PRN | 13.19 (0 to 28) | 5.93 (0 to 19) |
| T3 NPI NH nursing assistants in pts without PRN | 9.90 (0 to 19) | 4.38 (0 to 10) |
Collected over 12 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GROUP A - Control Group | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| GROUP B - Aromatherapy Group | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Age, Categorical(Participants) | GROUP A - Control Group | GROUP B - Aromatherapy Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 16 | 16 | 32 |
| Sex: Female, Male(Participants) | GROUP A - Control Group | GROUP B - Aromatherapy Group | Total |
|---|---|---|---|
| Female | 15 | 7 | 22 |
| Male | 1 | 9 | 10 |
| Race and Ethnicity Not Collected(Participants) | GROUP A - Control Group | GROUP B - Aromatherapy Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | GROUP A - Control Group | GROUP B - Aromatherapy Group | Total |
|---|---|---|---|
| Switzerland | 16 | 16 | 32 |
| patients admitted to the geriatric acute ward in may-june 2018 CLM(participants) | GROUP A - Control Group | GROUP B - Aromatherapy Group | Total |
|---|---|---|---|
| Number | 16 | 16 | 32 |
| patients with diagnosis of dementia associated with BPSD or diagnosis made during hospitalization(participants) | GROUP A - Control Group | GROUP B - Aromatherapy Group | Total |
|---|---|---|---|
| Number | 16 | 16 | 32 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — A UPN will be attributed to each patient. The dataset containing the correspondence between the UPN and the patient's personal and clinical data will be kept at the Clinical Research Unit of the Clinica Luganese Moncucco. All the analyzed data that will be published or available for scientific discussions will be codified.
Supporting information: Study protocol, Sap, Csr, Analytic code
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Clinica Luganese Moncucco