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

September 2, 2021 updated by: Pio Eugenio Fontana, Clinica Luganese Moncucco

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Ticino
      • Lugano, Ticino, Switzerland, 6900
        • Clinica Luganese Moncucco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: GROUP A - control group
16 patients who respect the inclusion criteria, treated with psychotropic drugs Pro Re Nata.
Experimental: 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
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
Other Names:
  • lavander essential oil
  • wild orange essential oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Role of Essential Oil Therapy in Environmental Diffusion as a Complement of Psychotropic Drugs in the Management of Psychological and Behavioral Disorders (BPSD)
Time Frame: 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.
Time 1 (baseline) and Time 3 (day 7)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Role of Essential Oil Therapy in Environmental Diffusion in Professional Caregiver Distress Linked to BPSD
Time Frame: 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.
Time 1 (baseline) and Time 3 (day 7)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica Luganese Moncucco

Investigators

  • Study Director: Alessandra Franzetti Pellanda, MD, Clinica Luganese Moncucco
  • Study Director: Pio Eugenio Fontana, MD, Clinica Luganese Moncucco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2018

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

July 30, 2018

Study Registration Dates

First Submitted

June 7, 2018

First Submitted That Met QC Criteria

September 6, 2018

First Posted (Actual)

September 7, 2018

Study Record Updates

Last Update Posted (Actual)

September 30, 2021

Last Update Submitted That Met QC Criteria

September 2, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLM_ds_p_02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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