BPSD (Behavioral and Psycological Symptoms of Dementia)
Conditions
Keywords
BPSD (behavioral and psycological symptoms of dementia), aromatherapy, elderly
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.
Interventions
OTHERessential 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
Sponsors
Clinica Luganese Moncucco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Role of Essential Oil Therapy in Environmental Diffusion as a Complement of Psychotropic Drugs in the Management of Psychological and Behavioral Disorders (BPSD) | 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
| Measure | Time frame | Description |
|---|---|---|
| Role of Essential Oil Therapy in Environmental Diffusion in Professional Caregiver Distress Linked to BPSD | Time 1 (baseline) and Time 3 (day 7) | 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. |
Countries
Switzerland
Participant flow
Recruitment details
NPI NH\> or = 1 at T1 (NPI-NH score from 0 to 144, patients with a score from 1 to 144 have been enrolled)
Participants by arm
| Arm | Count |
|---|---|
| GROUP A - Control Group 16 patients who respect the inclusion criteria, treated with psychotropic drugs. | 16 |
| GROUP B - Aromatherapy Group 16 patients included in the inclusion criteria, treated with psychotropic drugs and, in a complementary way, with diffusion aromatherapy
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 | 16 |
| Total | 32 |
Baseline characteristics
| Characteristic | GROUP A - Control Group | GROUP B - Aromatherapy Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 16 Participants | 16 Participants | 32 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| patients admitted to the geriatric acute ward in may-june 2018 CLM | 16 participants | 16 participants | 32 participants |
| patients with diagnosis of dementia associated with BPSD or diagnosis made during hospitalization | 16 participants | 16 participants | 32 participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Switzerland | 16 participants | 16 participants | 32 participants |
| Sex: Female, Male Female | 15 Participants | 7 Participants | 22 Participants |
| Sex: Female, Male Male | 1 Participants | 9 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 14 |
| other Total, other adverse events | 0 / 16 | 0 / 14 |
| serious Total, serious adverse events | 0 / 16 | 0 / 14 |
Outcome results
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 frame: Time 1 (baseline) and Time 3 (day 7)
Population: All participants with NPI-NH evaluated at Time 1 and Time 3
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| GROUP A - Control Group | Role of Essential Oil Therapy in Environmental Diffusion as a Complement of Psychotropic Drugs in the Management of Psychological and Behavioral Disorders (BPSD) | T1 NPI score in patients do not need Pro Re Nata | 21.81 score on a scale |
| GROUP A - Control Group | Role of Essential Oil Therapy in Environmental Diffusion as a Complement of Psychotropic Drugs in the Management of Psychological and Behavioral Disorders (BPSD) | T3 NPI score in patients needed Pro Re Nata | 32.87 score on a scale |
| GROUP A - Control Group | Role of Essential Oil Therapy in Environmental Diffusion as a Complement of Psychotropic Drugs in the Management of Psychological and Behavioral Disorders (BPSD) | T3 NPI score in patients do not need Pro Re Nata | 20.00 score on a scale |
| GROUP B - Aromatherapy Group | Role of Essential Oil Therapy in Environmental Diffusion as a Complement of Psychotropic Drugs in the Management of Psychological and Behavioral Disorders (BPSD) | T1 NPI score in patients do not need Pro Re Nata | 25.93 score on a scale |
| GROUP B - Aromatherapy Group | Role of Essential Oil Therapy in Environmental Diffusion as a Complement of Psychotropic Drugs in the Management of Psychological and Behavioral Disorders (BPSD) | T3 NPI score in patients needed Pro Re Nata | 16.5 score on a scale |
| GROUP B - Aromatherapy Group | Role of Essential Oil Therapy in Environmental Diffusion as a Complement of Psychotropic Drugs in the Management of Psychological and Behavioral Disorders (BPSD) | T3 NPI score in patients do not need Pro Re Nata | 7.25 score on a scale |
Comparison: The Mann-Whitney test has been used to evaluate the statistical significance of the difference between the variations in scores (T3 - T1) regarding the two interest groups of patients (control and treated).p-value: <0.001Wilcoxon (Mann-Whitney)
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 frame: Time 1 (baseline) and Time 3 (day 7)
Population: To evaluate the physicians, nurses and nursing assistants distress, both control and aromatherapy group were subdivided into two groups: use or not use of PNR. PNR was used at T3, so the difference between T1 and T3 was a comparison to evaluate the evolution of distress.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| GROUP A - Control Group | Role of Essential Oil Therapy in Environmental Diffusion in Professional Caregiver Distress Linked to BPSD | T1 NPI NH physicians in pts without PRN | 1.60 score on a scale |
| GROUP A - Control Group | Role of Essential Oil Therapy in Environmental Diffusion in Professional Caregiver Distress Linked to BPSD | T3 NPI NH physician in pts with PRN | 6.00 score on a scale |
| GROUP A - Control Group | Role of Essential Oil Therapy in Environmental Diffusion in Professional Caregiver Distress Linked to BPSD | T1 NPI NH nurses in pts without PRN | 6.40 score on a scale |
| GROUP A - Control Group | Role of Essential Oil Therapy in Environmental Diffusion in Professional Caregiver Distress Linked to BPSD | T3 NPI NH physician in pts without PRN | 3.20 score on a scale |
| GROUP A - Control Group | Role of Essential Oil Therapy in Environmental Diffusion in Professional Caregiver Distress Linked to BPSD | T1 NPI NH physicians in pts with PRN | 4.19 score on a scale |
| GROUP A - Control Group | Role of Essential Oil Therapy in Environmental Diffusion in Professional Caregiver Distress Linked to BPSD | T3 NPI NH nurses in pts with PRN | 12.00 score on a scale |
| GROUP A - Control Group | Role of Essential Oil Therapy in Environmental Diffusion in Professional Caregiver Distress Linked to BPSD | T1 NPI NH nursing assistants in pts with PRN | 11.00 score on a scale |
| GROUP A - Control Group | Role of Essential Oil Therapy in Environmental Diffusion in Professional Caregiver Distress Linked to BPSD | T3 NPI NH nurses in pts without PRN | 9.30 score on a scale |
| GROUP A - Control Group | Role of Essential Oil Therapy in Environmental Diffusion in Professional Caregiver Distress Linked to BPSD | T1 NPI NH nurses in pts with PRN | 9.63 score on a scale |
| GROUP A - Control Group | Role of Essential Oil Therapy in Environmental Diffusion in Professional Caregiver Distress Linked to BPSD | T3 NPI NH nursing assistants in pts with PRN | 13.19 score on a scale |
| GROUP A - Control Group | Role of Essential Oil Therapy in Environmental Diffusion in Professional Caregiver Distress Linked to BPSD | T1 NPI NH nursing assistants in pts without PRN | 7.10 score on a scale |
| GROUP A - Control Group | Role of Essential Oil Therapy in Environmental Diffusion in Professional Caregiver Distress Linked to BPSD | T3 NPI NH nursing assistants in pts without PRN | 9.90 score on a scale |
| GROUP B - Aromatherapy Group | Role of Essential Oil Therapy in Environmental Diffusion in Professional Caregiver Distress Linked to BPSD | T1 NPI NH nursing assistants in pts without PRN | 10.88 score on a scale |
| GROUP B - Aromatherapy Group | Role of Essential Oil Therapy in Environmental Diffusion in Professional Caregiver Distress Linked to BPSD | T1 NPI NH physicians in pts with PRN | 5.64 score on a scale |
| GROUP B - Aromatherapy Group | Role of Essential Oil Therapy in Environmental Diffusion in Professional Caregiver Distress Linked to BPSD | T1 NPI NH physicians in pts without PRN | 4.13 score on a scale |
| GROUP B - Aromatherapy Group | Role of Essential Oil Therapy in Environmental Diffusion in Professional Caregiver Distress Linked to BPSD | T1 NPI NH nurses in pts with PRN | 11.64 score on a scale |
| GROUP B - Aromatherapy Group | Role of Essential Oil Therapy in Environmental Diffusion in Professional Caregiver Distress Linked to BPSD | T1 NPI NH nurses in pts without PRN | 10.13 score on a scale |
| GROUP B - Aromatherapy Group | Role of Essential Oil Therapy in Environmental Diffusion in Professional Caregiver Distress Linked to BPSD | T1 NPI NH nursing assistants in pts with PRN | 12.21 score on a scale |
| GROUP B - Aromatherapy Group | Role of Essential Oil Therapy in Environmental Diffusion in Professional Caregiver Distress Linked to BPSD | T3 NPI NH nursing assistants in pts without PRN | 4.38 score on a scale |
| GROUP B - Aromatherapy Group | Role of Essential Oil Therapy in Environmental Diffusion in Professional Caregiver Distress Linked to BPSD | T3 NPI NH physician in pts with PRN | 2.64 score on a scale |
| GROUP B - Aromatherapy Group | Role of Essential Oil Therapy in Environmental Diffusion in Professional Caregiver Distress Linked to BPSD | T3 NPI NH physician in pts without PRN | 0.88 score on a scale |
| GROUP B - Aromatherapy Group | Role of Essential Oil Therapy in Environmental Diffusion in Professional Caregiver Distress Linked to BPSD | T3 NPI NH nurses in pts with PRN | 5.79 score on a scale |
| GROUP B - Aromatherapy Group | Role of Essential Oil Therapy in Environmental Diffusion in Professional Caregiver Distress Linked to BPSD | T3 NPI NH nurses in pts without PRN | 4.25 score on a scale |
| GROUP B - Aromatherapy Group | Role of Essential Oil Therapy in Environmental Diffusion in Professional Caregiver Distress Linked to BPSD | T3 NPI NH nursing assistants in pts with PRN | 5.93 score on a scale |
Comparison: The Mann-Whitney test has been used to evaluate the statistical significance of the difference between the variations scores in T3 and T1, concerning the distress of the professional caregivers in the two intereste groups of patientsp-value: <0.01Wilcoxon (Mann-Whitney)