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/NCT05961995</url>
    </required_header>
    <id_info>
      <org_study_id>2022H0078</org_study_id>
      <nct_id>NCT05961995</nct_id>
    </id_info>
    <brief_title>Heartfulness Meditation Cyclic Vomiting Syndrome</brief_title>
    <acronym>HFN in CVS</acronym>
    <official_title>Heartfulness Meditation: Acute and Long-term Effects on the Endocannabinoid Signaling System and Correlation With Psychological Outcomes in Cyclic Vomiting Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ohio State University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ohio State University</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>
        Cyclic vomiting syndrome (CVS) is a chronic disorder of gut-brain interaction (DGBI)&#xD;
        characterized by episodes of vomiting often triggered by stress. CVS affects 2% of the&#xD;
        population and has a disproportionate negative impact on patients and the healthcare system.&#xD;
        Although gastrointestinal symptoms are prominent, most patients have comorbid anxiety,&#xD;
        depression, high degrees of psychological distress, and other negative cognitive traits that&#xD;
        adversely affect health-related quality of life (HRQoL). This is independent of typical&#xD;
        measures of severity of CVS and warrants treatment. Recent guidelines recommend a&#xD;
        biopsychosocial model of care incorporating techniques like meditation to mitigate stress and&#xD;
        improve psychological outcomes in CVS. One potential approach to improve these outcomes is&#xD;
        the use of heartfulness (HFN) meditation.&#xD;
  &#xD;
        Heartfulness meditation is a secular, specific, guided meditation technique that includes&#xD;
        progressive relaxation with a concentrated focus on the heart. It is offered virtually and is&#xD;
        free-of charge ensuring no barriers to broad application in clinical practice. A pilot study&#xD;
        incorporating HFN meditation in CVS significantly reduced psychological distress, perceived&#xD;
        stress, and improved coping strategies, sleep quality, and HRQoL. Other data also show that&#xD;
        HFN meditation improves overall well-being and reduces perceived stress. However, there are&#xD;
        significant gaps in our understanding of the mechanism underlying HFN meditation and its&#xD;
        effects on patient outcomes.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 6, 2022</start_date>
    <completion_date type="Anticipated">January 2024</completion_date>
    <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Acute physiological effects of HFN Meditation on the endocannabinoid signaling system (ECSS)</measure>
      <time_frame>6 weeks</time_frame>
      <description>Conduct a prospective study to elucidate the acute effects of HFN meditation on the ECSS in CVS. We will measure circulating endocannabinoids and related lipids immediately before and after HFN meditation.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Correlate indices of ECSS with psychological state</measure>
      <time_frame>6 weeks</time_frame>
      <description>Measure stat anxiety with State Trait Anxiety Inventory (STAI) tool</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Correlate indices of ECSS with psychological state</measure>
      <time_frame>6 weeks</time_frame>
      <description>Measure state mood with Profile of Mood States (POMS) tool</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Long-term effects of HFN Meditation on the ECSS and correlation with psychological outcomes</measure>
      <time_frame>6 weeks</time_frame>
      <description>Measure psychological distress using Brief Symptom Inventory (BSI) questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Long-term effects of HFN Meditation on the ECSS and correlation with psychological outcomes</measure>
      <time_frame>6 weeks</time_frame>
      <description>Measure sleep quality using Pittsburgh Sleep Quality Index (PSQI) questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Long-term effects of HFN Meditation on the ECSS and correlation with psychological outcomes</measure>
      <time_frame>6 weeks</time_frame>
      <description>Measure Health-related quality of life (HRQOL) using Patient-Reported Outcomes Measurement Information System (PROMIS) quality of life questionnaire</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Cyclic Vomiting Syndrome</condition>
    <arm_group>
      <arm_group_label>HFN Meditation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects will complete guided meditation sessions 3 x a week for six weeks delivered in the app via video, as well as pre- and post-meditation psychological state assessments.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Heartfulness meditation</intervention_name>
      <description>Heartfulness meditation is a secular, specific, guided meditation technique that includes progressive relaxation with a concentrated focus on the heart.</description>
      <arm_group_label>HFN Meditation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients aged 18 - 80 years of age&#xD;
  &#xD;
            -  Diagnosed with CVS based on Rome criteria&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Major psychiatric illness such as schizophrenia, bipolar disease, and major depression&#xD;
               or anxiety that is not controlled with medication or requiring inpatient care within&#xD;
               the past year&#xD;
  &#xD;
            -  History of suicidal attempt/ideation in the past year&#xD;
  &#xD;
            -  Cognitive impairment that precludes the ability to meditate&#xD;
  &#xD;
            -  Inability to sit for at least 30 minutes&#xD;
  &#xD;
            -  Severe cardiopulmonary diseases, malignancy, or renal failure on dialysis&#xD;
  &#xD;
            -  Other organic gastrointestinal diseases or systemic diseases including but not limited&#xD;
               to inflammatory bowel disease and chronic liver diseases&#xD;
  &#xD;
            -  Pregnancy at the time of enrollment&#xD;
  &#xD;
            -  BMI &lt; 18 or &gt;35&#xD;
  &#xD;
            -  Regular cannabis use (defined as daily or near-daily cannabis use) and&#xD;
  &#xD;
            -  Individuals with significant prior meditation experience (continuous meditation&#xD;
               practice for ≥ 3 months within a year prior to the study).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Thangam Venkatesan, MD</last_name>
      <phone>614-293-6255</phone>
      <email>thangam.venkatesean@osumc.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Kebire Gofar, MD, MPH</last_name>
      <phone>614-293-8400</phone>
      <email>kebire.gofar@osumc.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The Ohio State University</name>
        <address>
          <city>Columbus</city>
          <state>Ohio</state>
          <zip>43210</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Thangam Venkatesan, MD</last_name>
        <phone>614-293-6255</phone>
        <email>thangam.venkatesan@osumc.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>April 2023</verification_date>
    <study_first_submitted>April 5, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 18, 2023</last_update_submitted>
    <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ohio State University</investigator_affiliation>
      <investigator_full_name>Thangam Venkatesan</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Syndrome</mesh_term>
      <mesh_term>Vomiting</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/NCT05961995
  org study id: 2022H0078
  nct id: NCT05961995
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Cyclic vomiting syndrome (CVS) is a chronic disorder of gut-brain interaction (DGBI)
        characterized by episodes of vomiting often triggered by stress. CVS affects 2% of the
        population and has a disproportionate negative impact on patients and the healthcare system.
        Although gastrointestinal symptoms are prominent, most patients have comorbid anxiety,
        depression, high degrees of psychological distress, and other negative cognitive traits that
        adversely affect health-related quality of life (HRQoL). This is independent of typical
        measures of severity of CVS and warrants treatment. Recent guidelines recommend a
        biopsychosocial model of care incorporating techniques like meditation to mitigate stress and
        improve psychological outcomes in CVS. One potential approach to improve these outcomes is
        the use of heartfulness (HFN) meditation.
  
        Heartfulness meditation is a secular, specific, guided meditation technique that includes
        progressive relaxation with a concentrated focus on the heart. It is offered virtually and is
        free-of charge ensuring no barriers to broad application in clinical practice. A pilot study
        incorporating HFN meditation in CVS significantly reduced psychological distress, perceived
        stress, and improved coping strategies, sleep quality, and HRQoL. Other data also show that
        HFN meditation improves overall well-being and reduces perceived stress. However, there are
        significant gaps in our understanding of the mechanism underlying HFN meditation and its
        effects on patient outcomes.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Acute physiological effects of HFN Meditation on the endocannabinoid signaling system (ECSS)
  time frame: 6 weeks
  description: Conduct a prospective study to elucidate the acute effects of HFN meditation on the ECSS in CVS. We will measure circulating endocannabinoids and related lipids immediately before and after HFN meditation.
  measure: Correlate indices of ECSS with psychological state
  time frame: 6 weeks
  description: Measure stat anxiety with State Trait Anxiety Inventory (STAI) tool
  measure: Correlate indices of ECSS with psychological state
  time frame: 6 weeks
  description: Measure state mood with Profile of Mood States (POMS) tool
  measure: Long-term effects of HFN Meditation on the ECSS and correlation with psychological outcomes
  time frame: 6 weeks
  description: Measure psychological distress using Brief Symptom Inventory (BSI) questionnaire
  measure: Long-term effects of HFN Meditation on the ECSS and correlation with psychological outcomes
  time frame: 6 weeks
  description: Measure sleep quality using Pittsburgh Sleep Quality Index (PSQI) questionnaire
  measure: Long-term effects of HFN Meditation on the ECSS and correlation with psychological outcomes
  time frame: 6 weeks
  description: Measure Health-related quality of life (HRQOL) using Patient-Reported Outcomes Measurement Information System (PROMIS) quality of life questionnaire
  arm group label: HFN Meditation
  arm group type: Experimental
  description: Subjects will complete guided meditation sessions 3 x a week for six weeks delivered in the app via video, as well as pre- and post-meditation psychological state assessments.
  intervention type: Behavioral
  intervention name: Heartfulness meditation
  description: Heartfulness meditation is a secular, specific, guided meditation technique that includes progressive relaxation with a concentrated focus on the heart.
  arm group label: HFN Meditation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Thangam Venkatesan, MD
  phone: 614-293-6255
  email: thangam.venkatesean@osumc.edu
  last name: Kebire Gofar, MD, MPH
  phone: 614-293-8400
  email: kebire.gofar@osumc.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Ohio State University
  investigator full name: Thangam Venkatesan
  investigator title: Principal Investigator
  mesh term: Syndrome
  mesh term: Vomiting
  sharing ipd: No