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

NCT ID: NCT05034107

Last Updated: 2022-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-30

Study Completion Date

2022-06-02

Brief Summary

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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

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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.

Conditions

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Dementia Behavioral and Psychiatric Symptoms of Dementia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Persons with dementia

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.

Group Type EXPERIMENTAL

Aromatherapy

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Ylang-Ylang Young LivingĀ® Essential Oils (Ylang-Ylang)

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universiti Sains Malaysia

OTHER

Sponsor Role collaborator

University of Malaya

OTHER

Sponsor Role collaborator

Universiti Teknologi Mara

OTHER

Sponsor Role lead

Responsible Party

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Shubashini Gnanasan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shubashini Gnanasan, PhD

Role: PRINCIPAL_INVESTIGATOR

Universiti Teknologi Mara

Locations

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Universiti Teknologi MARA

Kuala Selangor, Selangor, Malaysia

Site Status

Countries

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Malaysia

Other Identifiers

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FRGS/1/2017/SKK02/UITM/02/1

Identifier Type: -

Identifier Source: org_study_id

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