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

NCT05034107 | Completed DMC

• 1 other identifier: FRGS/1/2017/SKK02/UITM/02/1
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia; Behavioral and Psychiatric Symptoms of Dementia

Keywords

Aromatherapy; Ylang-Ylang; Behavioral and Psychological Symptoms of Dementia; Dementia

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (10)

• Serum BDNF (100μL)

  2 months

• Amyloid Beta (Aβ1-40) (100μL)

  2 months

• Amyloid Beta (Aβ1-42) (100μL)

  2 months

• cytokines (150μL )

  2 months

• Cortisol( 50μL)

  2 months

Study Arms (1)

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.

Other: Aromatherapy

Interventions

Aromatherapy 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.

Also known as: Ylang-Ylang, Young Living® Essential Oils (Ylang-Ylang)

Persons with dementia

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Teknologi Mara: lead
• Universiti Sains Malaysia: collaborator
• University of Malaya: collaborator

Study Sites (1)

Universiti Teknologi MARA

Kuala Selangor, Selangor, 42300, Malaysia

Location

MeSH Terms

Conditions

Dementia; Behavior

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Shubashini Gnanasan, PhD

  Universiti Teknologi Mara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 22, 2021
• First Posted: September 5, 2021
• Study Start: June 30, 2021
• Primary Completion: December 12, 2021
• Study Completion: June 2, 2022
• Last Updated: November 3, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)