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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Dementia, Behavioral and Psychiatric Symptoms of Dementia

Intervention / Treatment
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* Other: Aromatherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: A pre-post quasi-experimental study will be conducted over a two-month period in nursing homes with persons with dementia. During the pre-intervention phase, essential oil diffusers containing water will be diffused in the common area of the nursing homes. During the intervention phase, Ylang-Ylang essential oil will be diffused using an identical diffuser. Behavioural parameters and blood samples will be taken after pre and post intervention phase.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Persons with dementia<br>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<br>* 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.<br>* Other names: Young Living® Essential Oils (Ylang-Ylang);|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aromatherapy, Ylang-Ylang, Behavioral and Psychological Symptoms of Dementia, Dementia