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Completed

NCT Number: NCT05034107

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

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universiti Teknologi MARA

Kuala Selangor, Selangor, 42300, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aromatherapy

Other

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)

Primary outcomes

  1. 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. 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.

  3. 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.

Secondary outcomes

  1. Serum BDNF (100μL)

    Time frame: 2 months

    Enzyme linked immunosorbent assay (ELISA) will be used.

  2. Amyloid Beta (Aβ1-40) (100μL)

    Time frame: 2 months

    Enzyme linked immunosorbent assay (ELISA) will be used.

  3. Amyloid Beta (Aβ1-42) (100μL)

    Time frame: 2 months

    Enzyme linked immunosorbent assay (ELISA) will be used.

  4. cytokines (150μL )

    Time frame: 2 months

    IL-2, IL-6, IL-8, and TNF-α levels will be tested using Plex Proteomic Assay kit.

  5. Cortisol( 50μL)

    Time frame: 2 months

    Enzyme linked immunosorbent assay (ELISA) will be used.

  6. adrenocorticotropic hormone (50μL)

    Time frame: 2 months

    Enzyme linked immunosorbent assay (ELISA) will be used.

  7. MDA(Malondialdehyde) (50μL)

    Time frame: 2 months

    Enzyme linked immunosorbent assay (ELISA) will be used.

  8. Reduced Glutathione (GSH) (0.7 mL)

    Time frame: 2 months

    Colorimetric Assay Kit will be used.

  9. Thiobarbituric Acid Reactants (TBARS) (0.1mL)

    Time frame: 2 months

    Colorimetric Assay Kit will be used.

  10. Total Antioxidant Capacity (T-AOC) (10 μL)

    Time frame: 2 months

    Colorimetric Assay Kit will be used.

Sponsors and collaborators

Lead sponsor

Universiti Teknologi Mara

Other

Collaborators

  • Universiti Sains Malaysia
  • University of Malaya

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Sep 5, 2021
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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