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Elderly Demented Patients: Aromatherapy Complementary to Psychopharmacotherapy Psychological Disorders and BPSD Behavior

Primary Purpose

BPSD (Behavioral and Psycological Symptoms of Dementia)

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
essential oils
Sponsored by
Clinica Luganese Moncucco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for BPSD (Behavioral and Psycological Symptoms of Dementia) focused on measuring BPSD (behavioral and psycological symptoms of dementia), aromatherapy, elderly

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinica Luganese Moncucco

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

GROUP A - control group

GROUP B - aromatherapy group

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 7, 2018
Last Updated
September 2, 2021
Sponsor
Clinica Luganese Moncucco
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1. Study Identification

Unique Protocol Identification Number
NCT03662360
Brief Title
Elderly Demented Patients: Aromatherapy Complementary to Psychopharmacotherapy Psychological Disorders and BPSD Behavior
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 20, 2018 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
July 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinica Luganese Moncucco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
BPSD (Behavioral and Psycological Symptoms of Dementia)
Keywords
BPSD (behavioral and psycological symptoms of dementia), aromatherapy, elderly

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GROUP A - control group
Arm Type
No Intervention
Arm Description
16 patients who respect the inclusion criteria, treated with psychotropic drugs Pro Re Nata.
Arm Title
GROUP B - aromatherapy group
Arm Type
Experimental
Arm Description
16 patients included in the inclusion criteria, treated with psychotropic drugs Pro Re Nata and, in a complementary way, with diffusion aromatherapy
Intervention Type
Other
Intervention Name(s)
essential oils
Other Intervention Name(s)
lavander essential oil, wild orange essential oil
Intervention Description
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
Primary Outcome Measure Information:
Title
Role of Essential Oil Therapy in Environmental Diffusion as a Complement of Psychotropic Drugs in the Management of Psychological and Behavioral Disorders (BPSD)
Description
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)
Secondary Outcome Measure Information:
Title
Role of Essential Oil Therapy in Environmental Diffusion in Professional Caregiver Distress Linked to BPSD
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandra Franzetti Pellanda, MD
Organizational Affiliation
Clinica Luganese Moncucco
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Pio Eugenio Fontana, MD
Organizational Affiliation
Clinica Luganese Moncucco
Official's Role
Study Director
Facility Information:
Facility Name
Clinica Luganese Moncucco
City
Lugano
State/Province
Ticino
ZIP/Postal Code
6900
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
after the end of data collection
IPD Sharing Access Criteria
All the available data will be codified
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Links:
URL
http://www.uptodate.com/contents/mild-cognitive-impairment-epidemiology-pathology-and-clinical-assessment?search=mild%20cognitive%20impairment&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1
Description
details about mild cognitive impairment

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Elderly Demented Patients: Aromatherapy Complementary to Psychopharmacotherapy Psychological Disorders and BPSD Behavior

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