Universiti Teknologi MARA
Kuala Selangor, Selangor, 42300, Malaysia
NCT Number: NCT05034107
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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Notify Me40 year and older
All sexes
Interventional
Not applicable
Kuala Selangor, Selangor, 42300, Malaysia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
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.
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.
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.
Time frame: 2 months
Enzyme linked immunosorbent assay (ELISA) will be used.
Time frame: 2 months
Enzyme linked immunosorbent assay (ELISA) will be used.
Time frame: 2 months
Enzyme linked immunosorbent assay (ELISA) will be used.
Time frame: 2 months
IL-2, IL-6, IL-8, and TNF-α levels will be tested using Plex Proteomic Assay kit.
Time frame: 2 months
Enzyme linked immunosorbent assay (ELISA) will be used.
Time frame: 2 months
Enzyme linked immunosorbent assay (ELISA) will be used.
Time frame: 2 months
Enzyme linked immunosorbent assay (ELISA) will be used.
Time frame: 2 months
Colorimetric Assay Kit will be used.
Time frame: 2 months
Colorimetric Assay Kit will be used.
Time frame: 2 months
Colorimetric Assay Kit will be used.
Universiti Teknologi Mara
Other
Effects of Diffused Ylang-Ylang (Cananga Odorata) Essential Oil Amongst Older Persons With Dementia: A Pre-Post Quasi-Experimental Study Protocol
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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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