Effects of Diffused Ylang-Ylang Essential Oil Amongst Older Persons With Dementia

November 1, 2022 updated by: Shubashini Gnanasan, Universiti Teknologi Mara

Effects of Diffused Ylang-Ylang (Cananga Odorata) Essential Oil Amongst Older Persons With Dementia: A Pre-Post Quasi-Experimental Study Protocol

Ylang-Ylang (Cananga Odorata) essential oil has been postulated to have calming effect, which may improve BPSD in persons with dementia. This study aims to examine dementia-related behavioural changes using established assessment tools and brain derived neurotropic factor (BDNF) in persons with BPSD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Behavioural and Psychological Symptoms of Dementia (BPSD) refers to the spectrum of non-cognitive and non-neurological symptoms of dementia, such as agitation, psychosis, depression and apathy. Ylang-Ylang (Cananga Odorata) essential oil is postulated to have calming effect, which may improve BPSD in persons with dementia. Thus, this study aims to examine dementia-related behavioural changes using established assessment tools and brain derived neurotropic factor (BDNF) in persons with BPSD. A pre-post quasi-experimental pilot study will be conducted over a two-month period in nursing homes with persons with dementia. Approximately 30 persons with dementia are expected to participate in this study. During the pre-intervention phase, water will be diffused using a diffuser in a common area of the nursing homes. During the intervention phase, Ylang-Ylang essential oil will be diffused using the identical diffuser over the same common area. Both water and essential oil will be diffused twice a day, each for a duration of 20 min during the respective phases. Observation and documentation of behavioural symptoms will be taken using validated instruments during the pre- and post-intervention phases. In addition, 10 mL of blood will also be collected at pre and post intervention for biochemical analyses.If Ylang-ylang essential oil were found to be beneficial based on the laboratory and observational findings, it can be possibly used as an alternative approach in managing BPSD.

Study Type

Interventional

Enrollment (Actual)

28

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

  • Malaysia
    • Selangor
      • Kuala Selangor, Selangor, Malaysia, 42300
        • Universiti Teknologi Mara

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Persons who have been diagnosed with dementia by their physicians and in nursing homes in Selangor, Malaysia.
  • Persons with dementia who have at least one symptom of BPSD

Exclusion Criteria:

  • Persons with dementia with a comorbid respiratory problem like asthma or chronic obstructive pulmonary disease
  • Persons with dementia who are allergic to fragrance/perfumes
  • Persons with dementia who had a change in their psychotropic or dementia medications in the 30 days before commencement of the study, namely: acetylcholinesterase inhibitors N-methyl-D-aspartate (NMDA)-receptor antagonist (memantine), antipsychotics, antidepressants, sedatives, or medications with anticholinergic properties
  • Persons who have been diagnosed with schizophrenia or mental retardation
  • Persons who have no documented behavioral history in the previous three month
  • Persons who are currently hospitalized
  • Persons with dementia who are unwilling to participate or disallowed by caregivers/family members

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: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Persons with dementia
Persons who have been diagnosed with dementia by their physicians and in nursing homes. Persons with dementia who have at least one symptom of BPSD and willing to participate in this study. These participants will be exposed to diffused Ylang-Ylang aromatherapy.
Other: Aromatherapy
Approximately 6-7 drops of Ylang-ylang essential oil will be diffused in a common area estimated to be about 300 square feet with temperature of around 25 - 26 degree Celsius and humidity of 50% - 60%. Water and essential oil will be diffused twice a day, each for a duration of 20 min during the respective phases.
Other Names:
  • Ylang-Ylang
  • Young Living® Essential Oils (Ylang-Ylang)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cornell Scale for Depression in Dementia
Time Frame: 2 months
The mean counts of this parameter before and after intervention phase will be analysed using Cornell Scale for Depression in Dementia. The score more than 18 means the persons is having definite major depressive episode.
2 months
Cohen-Mansfield Agitation Inventory
Time Frame: 2 months
The mean counts of this parameter before and after the intervention phase will be analysed using Cohen-Mansfield Agitation Inventory. A rating of five indicates that the person is having frequent agitation within an hour.
2 months
Neuropsychiatric Inventory- Brief Questionnaire Form
Time Frame: 2 months
The mean counts of this parameter before and after the intervention phase will be analysed using the Neuropsychiatric Inventory- Brief Questionnaire Form. A person is undergoing severe symptoms of BPSD if the score is 3, while caregivers are undergoing more distress when the score is 5.
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum BDNF (100μL)
Time Frame: 2 months
Enzyme linked immunosorbent assay (ELISA) will be used.
2 months
Amyloid Beta (Aβ1-40) (100μL)
Time Frame: 2 months
Enzyme linked immunosorbent assay (ELISA) will be used.
2 months
Amyloid Beta (Aβ1-42) (100μL)
Time Frame: 2 months
Enzyme linked immunosorbent assay (ELISA) will be used.
2 months
cytokines (150μL )
Time Frame: 2 months
IL-2, IL-6, IL-8, and TNF-α levels will be tested using Plex Proteomic Assay kit.
2 months
Cortisol( 50μL)
Time Frame: 2 months
Enzyme linked immunosorbent assay (ELISA) will be used.
2 months
adrenocorticotropic hormone (50μL)
Time Frame: 2 months
Enzyme linked immunosorbent assay (ELISA) will be used.
2 months
MDA(Malondialdehyde) (50μL)
Time Frame: 2 months
Enzyme linked immunosorbent assay (ELISA) will be used.
2 months
Reduced Glutathione (GSH) (0.7 mL)
Time Frame: 2 months
Colorimetric Assay Kit will be used.
2 months
Thiobarbituric Acid Reactants (TBARS) (0.1mL)
Time Frame: 2 months
Colorimetric Assay Kit will be used.
2 months
Total Antioxidant Capacity (T-AOC) (10 μL)
Time Frame: 2 months
Colorimetric Assay Kit will be used.
2 months

Collaborators and Investigators

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

Sponsor

Universiti Teknologi Mara

Collaborators

University of Malaya
Universiti Sains Malaysia

Investigators

  • Principal Investigator: Shubashini Gnanasan, PhD, Universiti Teknologi Mara

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)

June 30, 2021

Primary Completion (Actual)

December 12, 2021

Study Completion (Actual)

June 2, 2022

Study Registration Dates

First Submitted

August 22, 2021

First Submitted That Met QC Criteria

August 27, 2021

First Posted (Actual)

September 5, 2021

Study Record Updates

Last Update Posted (Actual)

November 3, 2022

Last Update Submitted That Met QC Criteria

November 1, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FRGS/1/2017/SKK02/UITM/02/1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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