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Effects of Aromatherapy for Older Adults at Risk of Metabolic Syndrome in the Community

Primary Purpose

Metabolic Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Aromatherapy
Sponsored by
National Taipei University of Nursing and Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Metabolic Syndrome focused on measuring Aromatherapy, Older Adults at Risk of metabolic syndrome, quality of life, quality of sleep

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Students aged 65 or above in community care bases 2. People with normal sense of smell 3. No severe respiratory disease 4. Have any one of the metabolic syndrome risk factors According to the definition of the National Health Service: Abdominal obesity: waist circumference ≧90cm for men, waist circumference ≧80cm for women; High blood pressure: systolic blood pressure ≧ 130mmHg or diastolic blood pressure ≧ 85mmHg, or taking medication for hypertension prescribed by a doctor; High fasting blood sugar: fasting blood sugar ≧100mg/dL, or taking a doctor's prescription for diabetes treatment; High fasting triglycerides: ≧150mg/dL, or taking medicines for lowering triglycerides prescribed by doctors; Low high-density lipoprotein cholesterol: men <40mg/dL, women <50mg/dL, the above five items are risk factors, and three or more items are met as metabolic syndrome. 5. Complaints of sleep disorders 6. Those who agree and can cooperate with research activities Exclusion Criteria: Those who are allergic to essential oils Diagnosed with dementia, mental illness: such as depression Cancer patients Those who are currently using aromatherapy/have participated in or used aromatherapy-related activities within one month Currently there is a wound on the shoulder and neck

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    pre-specified group

    subgroup of participant

    Arm Description

    The experimental group received "aromatherapy", an intervention using lavender essential oil compound, while the control group received a placebo, sweet almond oil. The research tools include: "Basic Demographic Information", " The Chinese version of the Pittsburgh Sleep Quality Index, CPSQI ", "The World Health Organization Quality of Life Questionnaire -Taiwan Version" and ""The World Health Organization Quality of Life Questionnaire -old".

    The control group received a placebo, sweet almond oil. The research tools include: "Basic Demographic Information", " The Chinese version of the Pittsburgh Sleep Quality Index, CPSQI ", "The World Health Organization Quality of Life Questionnaire -Taiwan Version" and ""The World Health Organization Quality of Life Questionnaire -old".

    Outcomes

    Primary Outcome Measures

    The quality of sleep of elderly people at risk of metabolic syndrome in community bases participating in aromatherapy
    Basic Demographic Information", " The Chinese version of the Pittsburgh Sleep Quality Index, CPSQI
    The quality of life of elderly people at risk of metabolic syndrome in community bases participating in aromatherapy
    Basic Demographic Information","The World Health Organization Quality of Life Questionnaire -Taiwan Version" and ""The World Health Organization Quality of Life Questionnaire -old".

    Secondary Outcome Measures

    Full Information

    First Posted
    July 27, 2023
    Last Updated
    September 10, 2023
    Sponsor
    National Taipei University of Nursing and Health Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05987020
    Brief Title
    Effects of Aromatherapy for Older Adults at Risk of Metabolic Syndrome in the Community
    Official Title
    Effects of Aromatherapy on Sleep Quality and Quality of Life for Older Adults at Risk of Metabolic Syndrome in the Community
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 19, 2023 (Anticipated)
    Primary Completion Date
    February 28, 2024 (Anticipated)
    Study Completion Date
    April 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Taipei University of Nursing and Health Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Background: According to statistics, Taiwan will become a super-aged society in 2025, and health promotion and care for the elderly are important issues of public health. With the prolongation of life, the older adults need to face their physical weakness, decline in psychological, cognitive and social related functional abilities, the prevalence of chronic diseases and the increase in the disabled population, which has a considerable impact on individuals, families and the overall social economy. However, most older adults suffering from chronic diseases are often accompanied by physical dysfunction, which affects the quality of sleep, causes emotional distress and emotional disorders, and leads to a decline in the quality of life. Studies have found that aromatherapy can not only improve sleep and emotional problems, but also relieve physical discomfort caused by diseases, achieve the purpose of reducing medical costs and improving quality of life. However, there are very few studies regrading older adults who are at risk of metabolic syndrome in community and the effects of inhalation of compound essential oils on their sleep and quality of life. Therefore, this study will explore the use of aromatherapy to improve the quality of sleep and life of the elderly. The research results can be used as a reference for community bases to promote the improvement of sleep and quality of life for older adults, so as to achieve the goal of healthy aging.
    Detailed Description
    Objective: The purpose of this study is to understand the sleep status and quality of life of the older adults at risk of metabolic syndrome in the community and the potential contributing factors, and to explore the effect of aromatherapy on improving the sleep quality and quality of life of the older adults at risk of metabolic syndrome in the community. Methods: This study is a longitudinal study with a prospective randomized control design. A total of 64 elderly people were recruited from 2 community bases in the East District of Hsinchu City. The two bases were determined as the experimental group or the control group by simple randomization. The experimental group received "aromatherapy", an intervention using lavender essential oil compound, while the control group received a placebo, sweet almond oil. The research tools include: "Basic Demographic Information", " The Chinese version of the Pittsburgh Sleep Quality Index, CPSQI ", "The World Health Organization Quality of Life Questionnaire -Taiwan Version" and ""The World Health Organization Quality of Life Questionnaire -old". Expected results: Older Adults in the experimental group (use aromatherapy) had better sleep and quality of life than those who use placebo.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metabolic Syndrome
    Keywords
    Aromatherapy, Older Adults at Risk of metabolic syndrome, quality of life, quality of sleep

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    randomized controlled trial,RCT
    Masking
    Participant
    Masking Description
    single blinding
    Allocation
    Randomized
    Enrollment
    64 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    pre-specified group
    Arm Type
    Experimental
    Arm Description
    The experimental group received "aromatherapy", an intervention using lavender essential oil compound, while the control group received a placebo, sweet almond oil. The research tools include: "Basic Demographic Information", " The Chinese version of the Pittsburgh Sleep Quality Index, CPSQI ", "The World Health Organization Quality of Life Questionnaire -Taiwan Version" and ""The World Health Organization Quality of Life Questionnaire -old".
    Arm Title
    subgroup of participant
    Arm Type
    Placebo Comparator
    Arm Description
    The control group received a placebo, sweet almond oil. The research tools include: "Basic Demographic Information", " The Chinese version of the Pittsburgh Sleep Quality Index, CPSQI ", "The World Health Organization Quality of Life Questionnaire -Taiwan Version" and ""The World Health Organization Quality of Life Questionnaire -old".
    Intervention Type
    Other
    Intervention Name(s)
    Aromatherapy
    Intervention Description
    The experimental group received "aromatherapy", an intervention using lavender essential oil compound, while the control group received a placebo, sweet almond oil.
    Primary Outcome Measure Information:
    Title
    The quality of sleep of elderly people at risk of metabolic syndrome in community bases participating in aromatherapy
    Description
    Basic Demographic Information", " The Chinese version of the Pittsburgh Sleep Quality Index, CPSQI
    Time Frame
    1 month after intervention
    Title
    The quality of life of elderly people at risk of metabolic syndrome in community bases participating in aromatherapy
    Description
    Basic Demographic Information","The World Health Organization Quality of Life Questionnaire -Taiwan Version" and ""The World Health Organization Quality of Life Questionnaire -old".
    Time Frame
    1 month after intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Students aged 65 or above in community care bases 2. People with normal sense of smell 3. No severe respiratory disease 4. Have any one of the metabolic syndrome risk factors According to the definition of the National Health Service: Abdominal obesity: waist circumference ≧90cm for men, waist circumference ≧80cm for women; High blood pressure: systolic blood pressure ≧ 130mmHg or diastolic blood pressure ≧ 85mmHg, or taking medication for hypertension prescribed by a doctor; High fasting blood sugar: fasting blood sugar ≧100mg/dL, or taking a doctor's prescription for diabetes treatment; High fasting triglycerides: ≧150mg/dL, or taking medicines for lowering triglycerides prescribed by doctors; Low high-density lipoprotein cholesterol: men <40mg/dL, women <50mg/dL, the above five items are risk factors, and three or more items are met as metabolic syndrome. 5. Complaints of sleep disorders 6. Those who agree and can cooperate with research activities Exclusion Criteria: Those who are allergic to essential oils Diagnosed with dementia, mental illness: such as depression Cancer patients Those who are currently using aromatherapy/have participated in or used aromatherapy-related activities within one month Currently there is a wound on the shoulder and neck

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Effects of Aromatherapy for Older Adults at Risk of Metabolic Syndrome in the Community

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