<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/NCT02189980</url>
  </required_header>
  <id_info>
    <org_study_id>BHp2014-001</org_study_id>
    <nct_id>NCT02189980</nct_id>
  </id_info>
  <brief_title>Aromatherapy Using a Nasal Clip After Surgery</brief_title>
  <official_title>Aromatherapy Using a Nasal Clip After Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Balanced Health plus</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Balanced Health plus</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this follow up study is to determine the duration of action regarding&#xD;
      aromatherapy to treat nausea occurring postoperatively.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary hypothesis of the study is that post-operative patients who meet eligibility&#xD;
      criteria and report nausea and receive a blend of 45% ginger, 25% peppermint, 5% spearmint,&#xD;
      and 25% cardamom essential oils while using a nasal clip to facilitate inhalation will have&#xD;
      more relief from nausea than those who receive normal saline inhalation using the same&#xD;
      delivery system.&#xD;
&#xD;
      The secondary purposes of the study is to determine the duration of effectiveness of the&#xD;
      essential oil blend as compared to the saline in the relief of post-operative nausea and to&#xD;
      investigate the degree of comfort participants report using the nasal clip delivery system&#xD;
      for aromatherapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">August 2016</completion_date>
  <primary_completion_date type="Anticipated">August 2016</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of effectiveness of the essential oil blend</measure>
    <time_frame>Immediately to one-day post-operative</time_frame>
    <description>Evidence of effectiveness of tested aromatherapy blend in reducing symptoms of post-operative nausea as measured by patient self-report using Likert-type scale measure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Participant comfort using the nasal clip delivery system</measure>
    <time_frame>Immediately post-op to one-day post-op</time_frame>
    <description>Comfort of participants using nasal clip delivery system for aromatherapy will be measured by self-report using Likert-type scale.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Post-operative Nausea</condition>
  <arm_group>
    <arm_group_label>Saline &amp; nasal clip</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Saline and nasal clip inhaled post-operatively</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aromatherapy blend &amp; nasal clip</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Aromatherapy blend and nasal clip inhaled post-operatively</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Aromatherapy blend</intervention_name>
    <description>A blend of 45% ginger, 25% peppermint, 5% spearmint, and 25% cardamom essential oils</description>
    <arm_group_label>Aromatherapy blend &amp; nasal clip</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Duration of effectiveness of the essential oil blend</intervention_name>
    <description>Evidence of effectiveness of tested aromatherapy blend in reducing symptoms of post-operative nausea as measured by patient self-report using Likert-type scale measure immediately to one-day post-operative.</description>
    <arm_group_label>Aromatherapy blend &amp; nasal clip</arm_group_label>
    <arm_group_label>Saline &amp; nasal clip</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Participant comfort using the nasal clip delivery system</intervention_name>
    <description>Comfort of participants using nasal clip delivery system for aromatherapy will be measured by self-report using Likert-type scale immediately to one-day post-operative.</description>
    <arm_group_label>Aromatherapy blend &amp; nasal clip</arm_group_label>
    <arm_group_label>Saline &amp; nasal clip</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or over&#xD;
&#xD;
          -  cognitively able to give consent based on nurse's assessment,&#xD;
&#xD;
          -  having gynecological or other abdominal surgery&#xD;
&#xD;
          -  not allergic to peppermint, spearmint, cardamom or ginger&#xD;
&#xD;
          -  not receiving blood thinning medications&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  less than 18 years old&#xD;
&#xD;
          -  unable to cognitively give consent&#xD;
&#xD;
          -  allergic to ginger, peppermint, cardamom or spearmint.&#xD;
&#xD;
          -  receiving warfarin (Coumadin) or any antiplatelet drug (heparin, 325 mg Aspirin,&#xD;
             clopidogrel (Plavix) or other) or a diagnosis of bleeding diatheses (predisposition to&#xD;
             abnormal blood clotting/hemorrhage) will not be included in this study.&#xD;
&#xD;
          -  all surgeries other than gynecological or abdominal surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ronald Hunt, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Balanced Health plus</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ronald Hunt, MD</last_name>
    <phone>704-604-5031</phone>
    <email>rhunt@balancedhealthplus.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>CMC -- University</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28262</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ronald Hunt, MD</last_name>
      <phone>704-604-5031</phone>
      <email>rhunt@balancedhealthplus.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>January 14, 2016</last_update_submitted>
  <last_update_submitted_qc>January 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nausea</keyword>
  <keyword>Post-operative</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nausea</mesh_term>
    <mesh_term>Postoperative Nausea and Vomiting</mesh_term>
  </condition_browse>
  <!-- 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/NCT02189980
org study id: BHp2014-001
nct id: NCT02189980
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this follow up study is to determine the duration of action regarding
      aromatherapy to treat nausea occurring postoperatively.
The primary hypothesis of the study is that post-operative patients who meet eligibility
      criteria and report nausea and receive a blend of 45% ginger, 25% peppermint, 5% spearmint,
      and 25% cardamom essential oils while using a nasal clip to facilitate inhalation will have
      more relief from nausea than those who receive normal saline inhalation using the same
      delivery system.

      The secondary purposes of the study is to determine the duration of effectiveness of the
      essential oil blend as compared to the saline in the relief of post-operative nausea and to
      investigate the degree of comfort participants report using the nasal clip delivery system
      for aromatherapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Duration of effectiveness of the essential oil blend
time frame: Immediately to one-day post-operative
description: Evidence of effectiveness of tested aromatherapy blend in reducing symptoms of post-operative nausea as measured by patient self-report using Likert-type scale measure.
measure: Participant comfort using the nasal clip delivery system
time frame: Immediately post-op to one-day post-op
description: Comfort of participants using nasal clip delivery system for aromatherapy will be measured by self-report using Likert-type scale.
arm group label: Saline & nasal clip
arm group type: Placebo Comparator
description: Saline and nasal clip inhaled post-operatively
arm group label: Aromatherapy blend & nasal clip
arm group type: Experimental
description: Aromatherapy blend and nasal clip inhaled post-operatively
intervention type: Other
intervention name: Aromatherapy blend
description: A blend of 45% ginger, 25% peppermint, 5% spearmint, and 25% cardamom essential oils
arm group label: Aromatherapy blend & nasal clip
intervention type: Other
intervention name: Duration of effectiveness of the essential oil blend
description: Evidence of effectiveness of tested aromatherapy blend in reducing symptoms of post-operative nausea as measured by patient self-report using Likert-type scale measure immediately to one-day post-operative.
arm group label: Aromatherapy blend & nasal clip
arm group label: Saline & nasal clip
intervention type: Other
intervention name: Participant comfort using the nasal clip delivery system
description: Comfort of participants using nasal clip delivery system for aromatherapy will be measured by self-report using Likert-type scale immediately to one-day post-operative.
arm group label: Aromatherapy blend & nasal clip
arm group label: Saline & nasal clip
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ronald Hunt, MD
role: Principal Investigator
affiliation: Balanced Health plus
last name: Ronald Hunt, MD
phone: 704-604-5031
email: rhunt@balancedhealthplus.com
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Nausea
mesh term: Postoperative Nausea and Vomiting