Effects of Diffused Ylang-Ylang Essential Oil Amongst Older Persons With Dementia
Primary Purpose
Dementia, Behavioral and Psychiatric Symptoms of Dementia
Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Aromatherapy
Sponsored by
About this trial
This is an interventional supportive care trial for Dementia focused on measuring Aromatherapy, Ylang-Ylang, Behavioral and Psychological Symptoms of Dementia, Dementia
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
Sites / Locations
- Universiti Teknologi MARA
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Persons with dementia
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Serum BDNF (100μL)
Enzyme linked immunosorbent assay (ELISA) will be used.
Amyloid Beta (Aβ1-40) (100μL)
Enzyme linked immunosorbent assay (ELISA) will be used.
Amyloid Beta (Aβ1-42) (100μL)
Enzyme linked immunosorbent assay (ELISA) will be used.
cytokines (150μL )
IL-2, IL-6, IL-8, and TNF-α levels will be tested using Plex Proteomic Assay kit.
Cortisol( 50μL)
Enzyme linked immunosorbent assay (ELISA) will be used.
adrenocorticotropic hormone (50μL)
Enzyme linked immunosorbent assay (ELISA) will be used.
MDA(Malondialdehyde) (50μL)
Enzyme linked immunosorbent assay (ELISA) will be used.
Reduced Glutathione (GSH) (0.7 mL)
Colorimetric Assay Kit will be used.
Thiobarbituric Acid Reactants (TBARS) (0.1mL)
Colorimetric Assay Kit will be used.
Total Antioxidant Capacity (T-AOC) (10 μL)
Colorimetric Assay Kit will be used.
Full Information
NCT ID
NCT05034107
First Posted
August 22, 2021
Last Updated
November 1, 2022
Sponsor
Universiti Teknologi Mara
Collaborators
Universiti Sains Malaysia, University of Malaya
1. Study Identification
Unique Protocol Identification Number
NCT05034107
Brief Title
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 30, 2021 (Actual)
Primary Completion Date
December 12, 2021 (Actual)
Study Completion Date
June 2, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Teknologi Mara
Collaborators
Universiti Sains Malaysia, University of Malaya
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Behavioral and Psychiatric Symptoms of Dementia
Keywords
Aromatherapy, Ylang-Ylang, Behavioral and Psychological Symptoms of Dementia, Dementia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Persons with dementia
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Aromatherapy
Other Intervention Name(s)
Ylang-Ylang, Young Living® Essential Oils (Ylang-Ylang)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cornell Scale for Depression in Dementia
Description
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
Title
Cohen-Mansfield Agitation Inventory
Description
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
Title
Neuropsychiatric Inventory- Brief Questionnaire Form
Description
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
Secondary Outcome Measure Information:
Title
Serum BDNF (100μL)
Description
Enzyme linked immunosorbent assay (ELISA) will be used.
Time Frame
2 months
Title
Amyloid Beta (Aβ1-40) (100μL)
Description
Enzyme linked immunosorbent assay (ELISA) will be used.
Time Frame
2 months
Title
Amyloid Beta (Aβ1-42) (100μL)
Description
Enzyme linked immunosorbent assay (ELISA) will be used.
Time Frame
2 months
Title
cytokines (150μL )
Description
IL-2, IL-6, IL-8, and TNF-α levels will be tested using Plex Proteomic Assay kit.
Time Frame
2 months
Title
Cortisol( 50μL)
Description
Enzyme linked immunosorbent assay (ELISA) will be used.
Time Frame
2 months
Title
adrenocorticotropic hormone (50μL)
Description
Enzyme linked immunosorbent assay (ELISA) will be used.
Time Frame
2 months
Title
MDA(Malondialdehyde) (50μL)
Description
Enzyme linked immunosorbent assay (ELISA) will be used.
Time Frame
2 months
Title
Reduced Glutathione (GSH) (0.7 mL)
Description
Colorimetric Assay Kit will be used.
Time Frame
2 months
Title
Thiobarbituric Acid Reactants (TBARS) (0.1mL)
Description
Colorimetric Assay Kit will be used.
Time Frame
2 months
Title
Total Antioxidant Capacity (T-AOC) (10 μL)
Description
Colorimetric Assay Kit will be used.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shubashini Gnanasan, PhD
Organizational Affiliation
Universiti Teknologi Mara
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universiti Teknologi MARA
City
Kuala Selangor
State/Province
Selangor
ZIP/Postal Code
42300
Country
Malaysia
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Diffused Ylang-Ylang Essential Oil Amongst Older Persons With Dementia
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