<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/NCT03818490</url>
  </required_header>
  <id_info>
    <org_study_id>17-1200</org_study_id>
    <nct_id>NCT03818490</nct_id>
  </id_info>
  <brief_title>Aromatherapy for Anxiety Among Children With Autism Spectrum Disorder</brief_title>
  <official_title>Bergamot Aromatherapy for Anxiety in a Medical Office Among Children With Autism Spectrum Disorder: A Randomized, Controlled Trial</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>
      This study evaluated the use of bergamot aromatherapy in the treatment of anxiety in a&#xD;
      medical office setting among children who are diagnosed with an autism spectrum disorder. H&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Bergamot aromatherapy relieves anxiety in adult populations but has not been tested in a&#xD;
      pediatric population with autism spectrum disorder. Because autism spectrum disorders often&#xD;
      include hypersensitivity to sensory experiences, the use of essential oils in this population&#xD;
      should be evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 24, 2016</start_date>
  <completion_date type="Actual">March 30, 2018</completion_date>
  <primary_completion_date type="Actual">March 9, 2018</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline State Trait Anxiety Inventory for Children</measure>
    <time_frame>baseline and after the 15 minute intervention</time_frame>
    <description>Self reported anxiety survey measuring state anxiety in children through 20 questions with a score ranging from 0-60 with higher scores representing higher anxiety.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in Blood Pressure</measure>
    <time_frame>baseline and after the 15 minute intervention</time_frame>
    <description>Routine blood pressure measurement</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in Heart Rate</measure>
    <time_frame>baseline and after the 15 minute intervention</time_frame>
    <description>Routine heart rate measurement</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Anxiety</condition>
  <condition>Autism Spectrum Disorder</condition>
  <arm_group>
    <arm_group_label>Bergamot Aromatherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this group inhaled bergamot essential oil for 15 minutes at the start of their medical office visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in this group did not experience an intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Bergamot Aromatherapy</intervention_name>
    <description>Patients in this group inhaled bergamot essential oil for 15 minutes.</description>
    <arm_group_label>Bergamot Aromatherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between 6-11 years of age&#xD;
&#xD;
          -  Diagnosed with an autism spectrum disorder&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Franklin Institute of Wellness</name>
      <address>
        <city>Franklin</city>
        <state>Tennessee</state>
        <zip>37067</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>January 24, 2019</last_update_submitted>
  <last_update_submitted_qc>January 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Franklin Health Research</investigator_affiliation>
    <investigator_full_name>Jessie Hawkins, PhD</investigator_full_name>
    <investigator_title>Research Director</investigator_title>
  </responsible_party>
  <keyword>Aromatherapy</keyword>
  <keyword>Essential Oils</keyword>
  <keyword>Children</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
    <mesh_term>Autistic Disorder</mesh_term>
    <mesh_term>Autism Spectrum Disorder</mesh_term>
    <mesh_term>Child Development Disorders, Pervasive</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/NCT03818490
org study id: 17-1200
nct id: NCT03818490
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluated the use of bergamot aromatherapy in the treatment of anxiety in a
      medical office setting among children who are diagnosed with an autism spectrum disorder. H
Bergamot aromatherapy relieves anxiety in adult populations but has not been tested in a
      pediatric population with autism spectrum disorder. Because autism spectrum disorders often
      include hypersensitivity to sensory experiences, the use of essential oils in this population
      should be evaluated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change from baseline State Trait Anxiety Inventory for Children
time frame: baseline and after the 15 minute intervention
description: Self reported anxiety survey measuring state anxiety in children through 20 questions with a score ranging from 0-60 with higher scores representing higher anxiety.
measure: Change from baseline in Blood Pressure
time frame: baseline and after the 15 minute intervention
description: Routine blood pressure measurement
measure: Change from baseline in Heart Rate
time frame: baseline and after the 15 minute intervention
description: Routine heart rate measurement
arm group label: Bergamot Aromatherapy
arm group type: Experimental
description: Patients in this group inhaled bergamot essential oil for 15 minutes at the start of their medical office visit.
arm group label: Control
arm group type: No Intervention
description: Patients in this group did not experience an intervention.
intervention type: Other
intervention name: Bergamot Aromatherapy
description: Patients in this group inhaled bergamot essential oil for 15 minutes.
arm group label: Bergamot Aromatherapy
criteria: 
gender: All
minimum age: 6 Years
maximum age: 11 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Franklin Health Research
investigator full name: Jessie Hawkins, PhD
investigator title: Research Director
mesh term: Anxiety Disorders
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
mesh term: Child Development Disorders, Pervasive
sharing ipd: No