NCT05987020

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

September 19, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

2 months

First QC Date

July 27, 2023

Last Update Submit

November 7, 2023

Conditions

Keywords

AromatherapyOlder Adults at Risk of metabolic syndromequality of lifequality of sleep

Outcome Measures

Primary Outcomes (2)

  • 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

    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".

    1 month after intervention

Study Arms (2)

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".

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".

Other: Aromatherapy

Interventions

The experimental group received "aromatherapy", an intervention using lavender essential oil compound, while the control group received a placebo, sweet almond oil.

pre-specified groupsubgroup of participant

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.
  • \. Complaints of sleep disorders 6. Those who agree and can cooperate with research activities

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hsinchu Cathay General Hospital

Hsinchu, East Dist, 300, Taiwan

RECRUITING

MeSH Terms

Conditions

Metabolic SyndromeSleep Initiation and Maintenance Disorders

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPhytotherapySensory Art TherapiesPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
single blinding
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomized controlled trial,RCT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head nurse

Study Record Dates

First Submitted

July 27, 2023

First Posted

August 14, 2023

Study Start

September 19, 2023

Primary Completion

November 8, 2023

Study Completion

April 30, 2024

Last Updated

November 9, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations