DementiaNCT05034107
Effects of Diffused Ylang-Ylang Essential Oil Amongst Older Persons With Dementia
A study testing Aromatherapy in people with Dementia and Behavioral and Psychiatric Symptoms of Dementia, run by Universiti Teknologi Mara at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Dementia, Behavioral and Psychiatric Symptoms of Dementia
- What is being tested?
- Aromatherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteMalaysia
- Study dates
- 30 Jun 2021to 2 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Diffused Ylang-Ylang (Cananga Odorata) Essential Oil Amongst Older Persons With Dementia: A Pre-Post Quasi-Experimental Study Protocol
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.
Read the 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.
- Being tested
- Aromatherapy
- Keywords
- Aromatherapy, Ylang-Ylang, Behavioral and Psychological Symptoms of Dementia, Dementia
- Medical subject headings
- Dementia, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AromatherapyOther
Also called Ylang-Ylang, Young Living® Essential Oils (Ylang-Ylang)
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.
| Study group | Role | What they receive |
|---|---|---|
| Persons with dementia | Experimental | 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. Receives: Other: Aromatherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 2 months
Secondary outcomes (10)
Serum BDNF (100μL)
Enzyme linked immunosorbent assay (ELISA) will be used.
Measured: 2 months
Amyloid Beta (Aβ1-40) (100μL)
Enzyme linked immunosorbent assay (ELISA) will be used.
Measured: 2 months
Amyloid Beta (Aβ1-42) (100μL)
Enzyme linked immunosorbent assay (ELISA) will be used.
Measured: 2 months
cytokines (150μL )
IL-2, IL-6, IL-8, and TNF-α levels will be tested using Plex Proteomic Assay kit.
Measured: 2 months
Cortisol( 50μL)
Enzyme linked immunosorbent assay (ELISA) will be used.
Measured: 2 months
adrenocorticotropic hormone (50μL)
Enzyme linked immunosorbent assay (ELISA) will be used.
Measured: 2 months
MDA(Malondialdehyde) (50μL)
Enzyme linked immunosorbent assay (ELISA) will be used.
Measured: 2 months
Reduced Glutathione (GSH) (0.7 mL)
Colorimetric Assay Kit will be used.
Measured: 2 months
Thiobarbituric Acid Reactants (TBARS) (0.1mL)
Colorimetric Assay Kit will be used.
Measured: 2 months
Total Antioxidant Capacity (T-AOC) (10 μL)
Colorimetric Assay Kit will be used.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start30 Jun 2021
- Primary completion12 Dec 2021
- Study completion2 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Teknologi Mara
- Sponsor type
- University, hospital or other
- Collaborators
- Universiti Sains Malaysia, University of Malaya
- Responsible party
- Principal investigator, Shubashini Gnanasan, Universiti Teknologi Mara
- Investigators
- Shubashini Gnanasan, PhD, Principal investigator, Universiti Teknologi Mara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034107
- Sponsor's protocol ID
- FRGS/1/2017/SKK02/UITM/02/1
- Status last verified
- Nov 2022
- First submitted
- 22 Aug 2021
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Diffused Ylang-Ylang (Cananga Odorata) Essential Oil Amongst Older Persons With Dementia: A Pre-Post Quasi-Experimental Study Protocol
- ClinicalTrials.gov ID
- NCT05034107
- Acronym / sponsor ID
- FRGS/1/2017/SKK02/UITM/02/1
- Keywords
- Aromatherapy, Ylang-Ylang, Behavioral and Psychological Symptoms of Dementia, Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Universiti Teknologi MaraUniversity, hospital or other
- Collaborators
- Universiti Sains Malaysia, University of Malaya
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 12 Dec 2021 (actual)
- Study completion
- 2 Jun 2022 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Persons with dementia | Experimental | Other: AromatherapyPersons 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AromatherapyAlso: Ylang-Ylang, Young Living® Essential Oils (Ylang-Ylang)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 | Persons with dementia |
Primary outcome
Cornell Scale for Depression in Dementia
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.
Cohen-Mansfield Agitation Inventory
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.
Neuropsychiatric Inventory- Brief Questionnaire Form
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.
10 secondary outcomes
Serum BDNF (100μL)
Time frame: 2 months
Amyloid Beta (Aβ1-40) (100μL)
Time frame: 2 months
Amyloid Beta (Aβ1-42) (100μL)
Time frame: 2 months
cytokines (150μL )
Time frame: 2 months
Cortisol( 50μL)
Time frame: 2 months
adrenocorticotropic hormone (50μL)
Time frame: 2 months
MDA(Malondialdehyde) (50μL)
Time frame: 2 months
Reduced Glutathione (GSH) (0.7 mL)
Time frame: 2 months
Thiobarbituric Acid Reactants (TBARS) (0.1mL)
Time frame: 2 months
Total Antioxidant Capacity (T-AOC) (10 μL)
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shubashini Gnanasan, PhD principal investigator
Universiti Teknologi Mara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aromatherapy in people with Dementia and Behavioral and Psychiatric Symptoms of Dementia, run by Universiti Teknologi Mara at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cornell Scale for Depression in Dementia (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.