xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05987020</url>
    </required_header>
    <id_info>
      <org_study_id>Mei-Hui Wang</org_study_id>
      <nct_id>NCT05987020</nct_id>
    </id_info>
    <brief_title>Effects of Aromatherapy for Older Adults at Risk of Metabolic Syndrome in the Community</brief_title>
    <official_title>Effects of Aromatherapy on Sleep Quality and Quality of Life for Older Adults at Risk of Metabolic Syndrome in the Community</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Taipei University of Nursing and Health Sciences</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Taipei University of Nursing and Health Sciences</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Background: According to statistics, Taiwan will become a super-aged society in 2025, and&#xD;
        health promotion and care for the elderly are important issues of public health. With the&#xD;
        prolongation of life, the older adults need to face their physical weakness, decline in&#xD;
        psychological, cognitive and social related functional abilities, the prevalence of chronic&#xD;
        diseases and the increase in the disabled population, which has a considerable impact on&#xD;
        individuals, families and the overall social economy. However, most older adults suffering&#xD;
        from chronic diseases are often accompanied by physical dysfunction, which affects the&#xD;
        quality of sleep, causes emotional distress and emotional disorders, and leads to a decline&#xD;
        in the quality of life. Studies have found that aromatherapy can not only improve sleep and&#xD;
        emotional problems, but also relieve physical discomfort caused by diseases, achieve the&#xD;
        purpose of reducing medical costs and improving quality of life. However, there are very few&#xD;
        studies regrading older adults who are at risk of metabolic syndrome in community and the&#xD;
        effects of inhalation of compound essential oils on their sleep and quality of life.&#xD;
        Therefore, this study will explore the use of aromatherapy to improve the quality of sleep&#xD;
        and life of the elderly. The research results can be used as a reference for community bases&#xD;
        to promote the improvement of sleep and quality of life for older adults, so as to achieve&#xD;
        the goal of healthy aging.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Objective: The purpose of this study is to understand the sleep status and quality of life of&#xD;
        the older adults at risk of metabolic syndrome in the community and the potential&#xD;
        contributing factors, and to explore the effect of aromatherapy on improving the sleep&#xD;
        quality and quality of life of the older adults at risk of metabolic syndrome in the&#xD;
        community.&#xD;
  &#xD;
        Methods: This study is a longitudinal study with a prospective randomized control design. A&#xD;
        total of 64 elderly people were recruited from 2 community bases in the East District of&#xD;
        Hsinchu City. The two bases were determined as the experimental group or the control group by&#xD;
        simple randomization. The experimental group received &quot;aromatherapy&quot;, an intervention using&#xD;
        lavender essential oil compound, while the control group received a placebo, sweet almond&#xD;
        oil. The research tools include: &quot;Basic Demographic Information&quot;, &quot; The Chinese version of&#xD;
        the Pittsburgh Sleep Quality Index, CPSQI &quot;, &quot;The World Health Organization Quality of Life&#xD;
        Questionnaire -Taiwan Version&quot; and &quot;&quot;The World Health Organization Quality of Life&#xD;
        Questionnaire -old&quot;.&#xD;
  &#xD;
        Expected results: Older Adults in the experimental group (use aromatherapy) had better sleep&#xD;
        and quality of life than those who use placebo.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 19, 2023</start_date>
    <completion_date type="Anticipated">April 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 28, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>randomized controlled trial，RCT</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>single blinding</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>The quality of sleep of elderly people at risk of metabolic syndrome in community bases participating in aromatherapy</measure>
      <time_frame>1 month after intervention</time_frame>
      <description>Basic Demographic Information&quot;, &quot; The Chinese version of the Pittsburgh Sleep Quality Index, CPSQI</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The quality of life of elderly people at risk of metabolic syndrome in community bases participating in aromatherapy</measure>
      <time_frame>1 month after intervention</time_frame>
      <description>Basic Demographic Information&quot;,&quot;The World Health Organization Quality of Life Questionnaire -Taiwan Version&quot; and &quot;&quot;The World Health Organization Quality of Life Questionnaire -old&quot;.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">64</enrollment>
    <condition>Metabolic Syndrome</condition>
    <arm_group>
      <arm_group_label>pre-specified group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The experimental group received &quot;aromatherapy&quot;, an intervention using lavender essential oil compound, while the control group received a placebo, sweet almond oil. The research tools include: &quot;Basic Demographic Information&quot;, &quot; The Chinese version of the Pittsburgh Sleep Quality Index, CPSQI &quot;, &quot;The World Health Organization Quality of Life Questionnaire -Taiwan Version&quot; and &quot;&quot;The World Health Organization Quality of Life Questionnaire -old&quot;.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>subgroup of participant</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>The control group received a placebo, sweet almond oil. The research tools include: &quot;Basic Demographic Information&quot;, &quot; The Chinese version of the Pittsburgh Sleep Quality Index, CPSQI &quot;, &quot;The World Health Organization Quality of Life Questionnaire -Taiwan Version&quot; and &quot;&quot;The World Health Organization Quality of Life Questionnaire -old&quot;.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Aromatherapy</intervention_name>
      <description>The experimental group received &quot;aromatherapy&quot;, an intervention using lavender essential oil compound, while the control group received a placebo, sweet almond oil.</description>
      <arm_group_label>pre-specified group</arm_group_label>
      <arm_group_label>subgroup of participant</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Students aged 65 or above in community care bases 2. People with normal sense of smell 3.&#xD;
          No severe respiratory disease 4. Have any one of the metabolic syndrome risk factors&#xD;
  &#xD;
          According to the definition of the National Health Service:&#xD;
  &#xD;
            1. Abdominal obesity: waist circumference ≧90cm for men, waist circumference ≧80cm for&#xD;
               women;&#xD;
  &#xD;
            2. High blood pressure: systolic blood pressure ≧ 130mmHg or diastolic blood pressure ≧&#xD;
               85mmHg, or taking medication for hypertension prescribed by a doctor;&#xD;
  &#xD;
            3. High fasting blood sugar: fasting blood sugar ≧100mg/dL, or taking a doctor's&#xD;
               prescription for diabetes treatment;&#xD;
  &#xD;
            4. High fasting triglycerides: ≧150mg/dL, or taking medicines for lowering triglycerides&#xD;
               prescribed by doctors;&#xD;
  &#xD;
            5. Low high-density lipoprotein cholesterol: men &lt;40mg/dL, women &lt;50mg/dL, the above five&#xD;
               items are risk factors, and three or more items are met as metabolic syndrome.&#xD;
  &#xD;
          5. Complaints of sleep disorders 6. Those who agree and can cooperate with research&#xD;
          activities&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Those who are allergic to essential oils&#xD;
  &#xD;
            2. Diagnosed with dementia, mental illness: such as depression&#xD;
  &#xD;
            3. Cancer patients&#xD;
  &#xD;
            4. Those who are currently using aromatherapy/have participated in or used&#xD;
               aromatherapy-related activities within one month&#xD;
  &#xD;
            5. Currently there is a wound on the shoulder and neck&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>September 10, 2023</last_update_submitted>
    <last_update_submitted_qc>September 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>National Taipei University of Nursing and Health Sciences</investigator_affiliation>
      <investigator_full_name>Mei-Hui Wang</investigator_full_name>
      <investigator_title>Head nurse</investigator_title>
    </responsible_party>
    <keyword>Aromatherapy</keyword>
    <keyword>Older Adults at Risk of metabolic syndrome</keyword>
    <keyword>quality of life</keyword>
    <keyword>quality of sleep</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Metabolic Syndrome</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05987020
  org study id: Mei-Hui Wang
  nct id: NCT05987020
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: randomized controlled trial，RCT
  primary purpose: Supportive Care
  masking: Single (Participant)
  masking description: single blinding
  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
  description: Basic Demographic Information", " The Chinese version of the Pittsburgh Sleep Quality Index, CPSQI
  measure: The quality of life of elderly people at risk of metabolic syndrome in community bases participating in aromatherapy
  time frame: 1 month after intervention
  description: Basic Demographic Information","The World Health Organization Quality of Life Questionnaire -Taiwan Version" and ""The World Health Organization Quality of Life Questionnaire -old".
  arm group label: pre-specified group
  arm group type: Experimental
  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 group label: subgroup of participant
  arm group type: Placebo Comparator
  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: Aromatherapy
  description: The experimental group received "aromatherapy", an intervention using lavender essential oil compound, while the control group received a placebo, sweet almond oil.
  arm group label: pre-specified group
  arm group label: subgroup of participant
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: National Taipei University of Nursing and Health Sciences
  investigator full name: Mei-Hui Wang
  investigator title: Head nurse
  mesh term: Metabolic Syndrome
  mesh term: Syndrome
  sharing ipd: No