- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05987020
Effects of Aromatherapy for Older Adults at Risk of Metabolic Syndrome in the Community
Effects of Aromatherapy on Sleep Quality and Quality of Life for Older Adults at Risk of Metabolic Syndrome in the Community
Study Overview
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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East Dist
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Hsinchu, East Dist, Taiwan, 300
- Recruiting
- Hsinchu Cathay General Hospital
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Contact:
- Mei Hui Wang, Master
- Phone Number: 5201 +886-35278999
- Email: skywang@cgh.org.tw
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: pre-specified group
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 experimental group received "aromatherapy", an intervention using lavender essential oil compound, while the control group received a placebo, sweet almond oil.
|
Placebo Comparator: subgroup of participant
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 experimental group received "aromatherapy", an intervention using lavender essential oil compound, while the control group received a placebo, sweet almond oil.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The quality of sleep of elderly people at risk of metabolic syndrome in community bases participating in aromatherapy
Time Frame: 1 month after intervention
|
Basic Demographic Information", " The Chinese version of the Pittsburgh Sleep Quality Index, CPSQI
|
1 month after intervention
|
The quality of life of elderly people at risk of metabolic syndrome in community bases participating in aromatherapy
Time Frame: 1 month after intervention
|
Basic Demographic Information","The World Health Organization Quality of Life Questionnaire -Taiwan Version" and ""The World Health Organization Quality of Life Questionnaire -old".
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1 month after intervention
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mei-Hui Wang
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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