Clinical trial NCT05034107: Effects of Diffused Ylang-Ylang Essential Oil Amongst Older Persons With Dementia
Official title: Effects of Diffused Ylang-Ylang (Cananga Odorata) Essential Oil Amongst Older Persons With Dementia: A Pre-Post Quasi-Experimental Study Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Behavioral and Psychiatric Symptoms of Dementia
Keywords: Aromatherapy
Ylang-Ylang
Behavioral and Psychological Symptoms of Dementia
Dementia
Lead sponsor: Universiti Teknologi Mara
Sponsor class: OTHER
Collaborators: name: Universiti Sains Malaysia
name: University of Malaya
First posted: 2021-09-05
Enrollment: 28
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cornell Scale for Depression in Dementia
timeFrame: 2 months
measure: Cohen-Mansfield Agitation Inventory
timeFrame: 2 months
measure: Neuropsychiatric Inventory- Brief Questionnaire Form
timeFrame: 2 months
Secondary outcomes:
measure: Serum BDNF (100μL)
timeFrame: 2 months
measure: Amyloid Beta (Aβ1-40) (100μL)
timeFrame: 2 months
measure: Amyloid Beta (Aβ1-42) (100μL)
timeFrame: 2 months
measure: cytokines (150μL )
timeFrame: 2 months
measure: Cortisol( 50μL)
timeFrame: 2 months
measure: adrenocorticotropic hormone (50μL)
timeFrame: 2 months
measure: MDA(Malondialdehyde) (50μL)
timeFrame: 2 months
measure: Reduced Glutathione (GSH) (0.7 mL)
timeFrame: 2 months
measure: Thiobarbituric Acid Reactants (TBARS) (0.1mL)
timeFrame: 2 months
measure: Total Antioxidant Capacity (T-AOC) (10 μL)
timeFrame: 2 months
Other outcomes:
Locations:
city: Kuala Selangor
country: Malaysia
facility: Universiti Teknologi MARA
state: Selangor
Study officials:
affiliation: Universiti Teknologi Mara
name: Shubashini Gnanasan, PhD
role: PRINCIPAL_INVESTIGATOR
References: