Trial Outcomes & Findings for Elderly Demented Patients: Aromatherapy Complementary to Psychopharmacotherapy Psychological Disorders and BPSD Behavior (NCT NCT03662360)
NCT ID: NCT03662360
Last Updated: 2021-09-30
Results Overview
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.
COMPLETED
NA
32 participants
Time 1 (baseline) and Time 3 (day 7)
2021-09-30
Participant Flow
NPI NH\> or = 1 at T1 (NPI-NH score from 0 to 144, patients with a score from 1 to 144 have been enrolled)
Participant milestones
| Measure |
GROUP A - Control Group
16 patients who respect the inclusion criteria, treated with psychotropic drugs Pro Re Nata.
|
GROUP B - Aromatherapy Group
16 patients included in the inclusion criteria, treated with psychotropic drugs Pro Re Nata 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
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
GROUP A - Control Group
n=16 Participants
16 patients who respect the inclusion criteria, treated with psychotropic drugs.
|
GROUP B - Aromatherapy Group
n=16 Participants
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
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=16 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=32 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=16 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=32 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=16 Participants
|
16 Participants
n=16 Participants
|
32 Participants
n=32 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=16 Participants
|
7 Participants
n=16 Participants
|
22 Participants
n=32 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=16 Participants
|
9 Participants
n=16 Participants
|
10 Participants
n=32 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Switzerland
|
16 participants
n=16 Participants
|
16 participants
n=16 Participants
|
32 participants
n=32 Participants
|
|
patients admitted to the geriatric acute ward in may-june 2018 CLM
|
16 participants
n=16 Participants
|
16 participants
n=16 Participants
|
32 participants
n=32 Participants
|
|
patients with diagnosis of dementia associated with BPSD or diagnosis made during hospitalization
|
16 participants
n=16 Participants
|
16 participants
n=16 Participants
|
32 participants
n=32 Participants
|
PRIMARY outcome
Timeframe: Time 1 (baseline) and Time 3 (day 7)Population: All participants with NPI-NH evaluated at Time 1 and Time 3
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.
Outcome measures
| Measure |
GROUP A - Control Group
n=16 Participants
16 patients who respect the inclusion criteria, treated with psychotropic drugs Pro Re Nata.
|
GROUP B - Aromatherapy Group
n=14 Participants
16 patients included in the inclusion criteria, treated with psychotropic drugs Pro Re Nata 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
|
|---|---|---|
|
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
Interval 6.0 to 42.0
|
25.93 score on a scale
Interval 9.0 to 60.0
|
|
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
Interval 18.0 to 51.0
|
16.5 score on a scale
Interval 9.0 to 33.0
|
|
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
Interval 5.0 to 42.0
|
7.25 score on a scale
Interval 5.0 to 10.0
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
GROUP A - Control Group
n=16 Participants
16 patients who respect the inclusion criteria, treated with psychotropic drugs Pro Re Nata.
|
GROUP B - Aromatherapy Group
n=14 Participants
16 patients included in the inclusion criteria, treated with psychotropic drugs Pro Re Nata 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
|
|---|---|---|
|
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
Interval 0.0 to 18.0
|
5.64 score on a scale
Interval 0.0 to 15.0
|
|
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
Interval 0.0 to 9.0
|
4.13 score on a scale
Interval 0.0 to 20.0
|
|
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
Interval 0.0 to 25.0
|
11.64 score on a scale
Interval 0.0 to 21.0
|
|
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
Interval 0.0 to 14.0
|
10.13 score on a scale
Interval 0.0 to 27.0
|
|
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
Interval 0.0 to 27.0
|
12.21 score on a scale
Interval 0.0 to 23.0
|
|
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
Interval 0.0 to 15.0
|
10.88 score on a scale
Interval 0.0 to 31.0
|
|
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
Interval 0.0 to 21.0
|
2.64 score on a scale
Interval 0.0 to 15.0
|
|
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
Interval 0.0 to 12.0
|
0.88 score on a scale
Interval 0.0 to 6.0
|
|
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
Interval 0.0 to 27.0
|
5.79 score on a scale
Interval 0.0 to 19.0
|
|
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
Interval 0.0 to 19.0
|
4.25 score on a scale
Interval 0.0 to 10.0
|
|
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
Interval 0.0 to 28.0
|
5.93 score on a scale
Interval 0.0 to 19.0
|
|
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
Interval 0.0 to 19.0
|
4.38 score on a scale
Interval 0.0 to 10.0
|
Adverse Events
GROUP A - Control Group
GROUP B - Aromatherapy Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place