An interventional study of Aromatherapy in Dementia and Behavioral and Psychiatric Symptoms of Dementia, sponsored by Universiti Teknologi Mara. Completed at 1 site in Malaysia. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2022-11-03.
Sponsored by Universiti Teknologi Mara · Not applicable, Interventional, and Supportive care
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.
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.
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's enrollment of 28 is below the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →Universiti Teknologi Mara is the lead sponsor of 24 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
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.
Also known as: Ylang-Ylang, Young Living® Essential Oils (Ylang-Ylang)
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.
Time frame: 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.
Time frame: 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.
Time frame: 2 months
Serum BDNF (100μL)
Enzyme linked immunosorbent assay (ELISA) will be used.
Time frame: 2 months
Amyloid Beta (Aβ1-40) (100μL)
Enzyme linked immunosorbent assay (ELISA) will be used.
Time frame: 2 months
Amyloid Beta (Aβ1-42) (100μL)
Enzyme linked immunosorbent assay (ELISA) will be used.
Time frame: 2 months
cytokines (150μL )
IL-2, IL-6, IL-8, and TNF-α levels will be tested using Plex Proteomic Assay kit.
Time frame: 2 months
Cortisol( 50μL)
Enzyme linked immunosorbent assay (ELISA) will be used.
Time frame: 2 months
adrenocorticotropic hormone (50μL)
Enzyme linked immunosorbent assay (ELISA) will be used.
Time frame: 2 months
MDA(Malondialdehyde) (50μL)
Enzyme linked immunosorbent assay (ELISA) will be used.
Time frame: 2 months
Reduced Glutathione (GSH) (0.7 mL)
Colorimetric Assay Kit will be used.
Time frame: 2 months
Thiobarbituric Acid Reactants (TBARS) (0.1mL)
Colorimetric Assay Kit will be used.
Time frame: 2 months
Total Antioxidant Capacity (T-AOC) (10 μL)
Colorimetric Assay Kit will be used.
Time frame: 2 months
Plan to share: No
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This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Universiti Teknologi Mara