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

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05034107
• Other study ID #: FRGS/1/2017/SKK02/UITM/02/1
• Status: Completed
• Phase: N/A
• Start date: June 30, 2021
• Est. completion date: June 2, 2022

Study information

• Verified date: November 2022
• Source: Universiti Teknologi Mara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2, 2022
• Est. primary completion date: December 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Behavioral and Psychiatric Symptoms of Dementia
• Dementia

Intervention

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.

Locations

Country	Name	City	State
Malaysia	Universiti Teknologi MARA	Kuala Selangor	Selangor

Sponsors (3)

Lead Sponsor	Collaborator
Universiti Teknologi Mara	Universiti Sains Malaysia, University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Serum BDNF (100µL)	Enzyme linked immunosorbent assay (ELISA) will be used.	2 months
Secondary	Amyloid Beta (Aß1-40) (100µL)	Enzyme linked immunosorbent assay (ELISA) will be used.	2 months
Secondary	Amyloid Beta (Aß1-42) (100µL)	Enzyme linked immunosorbent assay (ELISA) will be used.	2 months
Secondary	cytokines (150µL )	IL-2, IL-6, IL-8, and TNF-a levels will be tested using Plex Proteomic Assay kit.	2 months
Secondary	Cortisol( 50µL)	Enzyme linked immunosorbent assay (ELISA) will be used.	2 months
Secondary	adrenocorticotropic hormone (50µL)	Enzyme linked immunosorbent assay (ELISA) will be used.	2 months
Secondary	MDA(Malondialdehyde) (50µL)	Enzyme linked immunosorbent assay (ELISA) will be used.	2 months
Secondary	Reduced Glutathione (GSH) (0.7 mL)	Colorimetric Assay Kit will be used.	2 months
Secondary	Thiobarbituric Acid Reactants (TBARS) (0.1mL)	Colorimetric Assay Kit will be used.	2 months
Secondary	Total Antioxidant Capacity (T-AOC) (10 µL)	Colorimetric Assay Kit will be used.	2 months