Metabolic SyndromeNCT05987020
Effects of Aromatherapy for Older Adults at Risk of Metabolic Syndrome in the Community
A study testing Aromatherapy in people with Metabolic Syndrome, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Aromatherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Sep 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Hsinchu Cathay General Hospital
Hsinchu, East Dist, 300
Mei Hui Wang, Master, +886-35278999 ext. 5201, skywang@cgh.org.tw
About this study
Official title: Effects of Aromatherapy on Sleep Quality and Quality of Life for Older Adults at Risk of Metabolic Syndrome in the Community
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.
Read the 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.
- Conditions
- Metabolic Syndrome
- Being tested
- Aromatherapy
- Keywords
- Aromatherapy, Older Adults at Risk of metabolic syndrome, quality of life, quality of sleep
- Medical subject headings
- Metabolic Syndrome, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AromatherapyOther
The experimental group received "aromatherapy", an intervention using lavender essential oil compound, while the control group received a placebo, sweet almond oil.
| Study group | Role | What they receive |
|---|---|---|
| pre-specified group | Experimental | 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". Receives: Other: Aromatherapy |
| subgroup of participant | Placebo comparator | 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". Receives: Other: Aromatherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month after intervention
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".
Measured: 1 month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start19 Sep 2023
- Primary completion8 Nov 2023
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial，RCT
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mei-Hui Wang, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05987020
- Sponsor's protocol ID
- Mei-Hui Wang
- Status last verified
- Nov 2023
- First submitted
- 27 Jul 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aromatherapy on Sleep Quality and Quality of Life for Older Adults at Risk of Metabolic Syndrome in the Community
- ClinicalTrials.gov ID
- NCT05987020
- Acronym / sponsor ID
- Mei-Hui Wang
- Conditions
- Metabolic Syndrome
- Keywords
- Aromatherapy, Older Adults at Risk of metabolic syndrome, quality of life, quality of sleep
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 8 Nov 2023 (actual)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized controlled trial，RCT
| Arm | Type | Receives |
|---|---|---|
| pre-specified group | Experimental | Other: AromatherapyThe 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". |
| subgroup of participant | Placebo comparator | Other: AromatherapyThe 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". |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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
- 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;
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AromatherapyThe experimental group received "aromatherapy", an intervention using lavender essential oil compound, while the control group received a placebo, sweet almond oil. | Other | pre-specified group, subgroup of participant |
Primary outcome
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
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".
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aromatherapy in people with Metabolic Syndrome, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The quality of sleep of elderly people at risk of metabolic syndrome in community bases participating in aromatherapy (time frame: 1 month after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.