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

NCT03662360 | Completed Results

• 1 other identifier: CLM_ds_p_02
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

BPSD (Behavioral and Psycological Symptoms of Dementia)

Keywords

BPSD (behavioral and psycological symptoms of dementia); aromatherapy; elderly

Outcome Measures

Primary Outcomes (1)

• 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 1 (baseline) and Time 3 (day 7)

Secondary Outcomes (1)

• Role of Essential Oil Therapy in Environmental Diffusion in Professional Caregiver Distress Linked to BPSD

  Time 1 (baseline) and Time 3 (day 7)

Study Arms (2)

GROUP A - control group

NO INTERVENTION

16 patients who respect the inclusion criteria, treated with psychotropic drugs Pro Re Nata.

GROUP B - aromatherapy group

EXPERIMENTAL

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

Interventions

essential oils OTHER

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

GROUP B - aromatherapy group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• patients admitted to the acute geriatric ward;
• patients with a known diagnosis of dementia associated with BPSD or diagnosis performed during hospitalization.

You may not qualify if:

• patients with alcohol-based dementia;
• patients with Mild Cognitive Impairment (MCI) - section 4 -;
• patients with language barrier;
• patients already being treated with aromatherapy.

Sponsors & Collaborators

• Clinica Luganese Moncucco: lead

Study Sites (1)

Clinica Luganese Moncucco

Lugano, Canton Ticino, 6900, Switzerland

Location

Related Publications (25)

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Related Links

• details about mild cognitive impairment

MeSH Terms

Conditions

Behavior

Interventions

Oils, Volatile

Intervention Hierarchy (Ancestors)

Oils; Lipids

Results Point of Contact

• Title: Dr. Med. Pio Fontana
• Organization: Clinica Luganese Moncucco

pioeugenio.fontana@moncucco.ch

0041919608712

Study Officials

• Alessandra Franzetti Pellanda, MD

  Clinica Luganese Moncucco

  STUDY DIRECTOR

• Pio Eugenio Fontana, MD

  Clinica Luganese Moncucco

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Geriatric Division

Model Details: 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

Study Record Dates

• First Submitted: June 7, 2018
• First Posted: September 7, 2018
• Study Start: May 20, 2018
• Primary Completion: June 30, 2018
• Study Completion: July 30, 2018
• Last Updated: September 30, 2021
• Results First Posted: September 30, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: after the end of data collection
• Access Criteria: All the available data will be codified

Locations

CH (1)