跳至主要内容
临床试验/NCT05034107
NCT05034107已完成不适用

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

Universiti Teknologi Mara1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2021年6月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
1
主要终点
Cornell Scale for Depression in Dementia

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Aromatherapy (Other)

结局指标

主要结局

Cornell Scale for Depression in Dementia

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • MDA(Malondialdehyde) (50μL)(2 months)
  • cytokines (150μL )(2 months)
  • adrenocorticotropic hormone (50μL)(2 months)
  • Serum BDNF (100μL)(2 months)
  • Amyloid Beta (Aβ1-40) (100μL)(2 months)
  • Amyloid Beta (Aβ1-42) (100μL)(2 months)
  • Cortisol( 50μL)(2 months)
  • Reduced Glutathione (GSH) (0.7 mL)(2 months)
  • Thiobarbituric Acid Reactants (TBARS) (0.1mL)(2 months)
  • Total Antioxidant Capacity (T-AOC) (10 μL)(2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shubashini Gnanasan

Principal Investigator

Universiti Teknologi Mara

研究点 (1)

Loading locations...

相似试验