<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/NCT04495842</url>
  </required_header>
  <id_info>
    <org_study_id>20-7-5600</org_study_id>
    <nct_id>NCT04495842</nct_id>
  </id_info>
  <brief_title>The Effect of Aromatherapy on COVID-19-induced Anxiety</brief_title>
  <official_title>The Effect of Aromatherapy on COVID-19-induced Anxiety</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Franklin Health Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Franklin Health Research</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>
      The purpose of this study is to assess the potential for a non-invasive sensory based&#xD;
      intervention to reduce the stress associated with a COVID-19 diagnosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After being informed about the study, participants who provide consent will be randomized to&#xD;
      one of two groups. Participants will receive one of two aromas to inhale with one being&#xD;
      active and the other a control comparison.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Anticipated">March 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in state anxiety on the State portion of the State Trait Anxiety Scale (STAI-S) at 15 minutes</measure>
    <time_frame>Baseline and at 15 minutes</time_frame>
    <description>The STAI-S is a validated self reporting instrument which assesses anxious feelings at that specific moment in time. Possible scores range from 20 to 60, with higher scores pointing to higher anxiety. The STAI-S contains 20 questions which are answered on a Likert scale.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in mood state on the Abbreviated Profile of Mood States (POMS)</measure>
    <time_frame>Baseline and at 15 minutes</time_frame>
    <description>This instrument contains 40 words such as Lively or Sad, each of which are scored on a scale of 0-4 indicating how much that word refects what they feel in that moment. Scores range from 0-160 with higher scores indicating greater mood disturbances across 7 subscales.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Stress</condition>
  <condition>Covid19</condition>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive an active essential oil blend to inhale for 15 minutes. The blend contains plant based oils sourced from flowers and citrus plants.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants receive an inert comparison to inhale for 15 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Essential Oil Blend</intervention_name>
    <description>5 drops of on a tester strip</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control Blend</intervention_name>
    <description>5 drops on a tester strip</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Otherwise healthy&#xD;
&#xD;
          -  Documented COVID-19 exposure, suspected infection, or diagnosed infection&#xD;
&#xD;
          -  Has been tested for or diagnosed with COVID-19&#xD;
&#xD;
          -  adults age 18-65 living in the US&#xD;
&#xD;
          -  understands and agrees to comply with study procedures&#xD;
&#xD;
          -  provides informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smoker in household&#xD;
&#xD;
          -  Pregnant or may become pregnant&#xD;
&#xD;
          -  Difficulty breathing&#xD;
&#xD;
          -  Pain or pressure in the chest&#xD;
&#xD;
          -  Confusion&#xD;
&#xD;
          -  Hospitalization&#xD;
&#xD;
          -  Asthma, COPD, or other respiratory condition&#xD;
&#xD;
          -  demonstrated inability to comply with study procedures&#xD;
&#xD;
          -  has participated in an interventional clinical study within 31 days prior to&#xD;
             enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jessie Hawkins, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Franklin Health Research</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>PI</last_name>
    <phone>6152613116</phone>
    <email>info@franklinhealth.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Franklin Health Research Center</name>
      <address>
        <city>Franklin</city>
        <state>Tennessee</state>
        <zip>37067</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jessie Hawkins, PhD</last_name>
      <phone>615-642-1919</phone>
      <email>j.hawkins@franklinhealth.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>July 27, 2021</last_update_submitted>
  <last_update_submitted_qc>July 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>aromatherapy</keyword>
  <keyword>essential oils</keyword>
  <keyword>environmental health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04495842
org study id: 20-7-5600
nct id: NCT04495842
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess the potential for a non-invasive sensory based
      intervention to reduce the stress associated with a COVID-19 diagnosis.
After being informed about the study, participants who provide consent will be randomized to
      one of two groups. Participants will receive one of two aromas to inhale with one being
      active and the other a control comparison.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Change from baseline in state anxiety on the State portion of the State Trait Anxiety Scale (STAI-S) at 15 minutes
time frame: Baseline and at 15 minutes
description: The STAI-S is a validated self reporting instrument which assesses anxious feelings at that specific moment in time. Possible scores range from 20 to 60, with higher scores pointing to higher anxiety. The STAI-S contains 20 questions which are answered on a Likert scale.
measure: Change from baseline in mood state on the Abbreviated Profile of Mood States (POMS)
time frame: Baseline and at 15 minutes
description: This instrument contains 40 words such as Lively or Sad, each of which are scored on a scale of 0-4 indicating how much that word refects what they feel in that moment. Scores range from 0-160 with higher scores indicating greater mood disturbances across 7 subscales.
arm group label: Intervention
arm group type: Experimental
description: Participants receive an active essential oil blend to inhale for 15 minutes. The blend contains plant based oils sourced from flowers and citrus plants.
arm group label: Control
arm group type: Placebo Comparator
description: Participants receive an inert comparison to inhale for 15 minutes.
intervention type: Other
intervention name: Essential Oil Blend
description: 5 drops of on a tester strip
arm group label: Intervention
intervention type: Other
intervention name: Control Blend
description: 5 drops on a tester strip
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jessie Hawkins, PhD
role: Principal Investigator
affiliation: Franklin Health Research
last name: PI
phone: 6152613116
email: info@franklinhealth.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Anxiety Disorders
sharing ipd: No