<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/NCT04482647</url>
  </required_header>
  <id_info>
    <org_study_id>2020-0483</org_study_id>
    <secondary_id>NCI-2020-04931</secondary_id>
    <secondary_id>2020-0483</secondary_id>
    <nct_id>NCT04482647</nct_id>
  </id_info>
  <brief_title>Breathing Techniques and Meditation for Health Care Workers During COVID-19 Pandemic</brief_title>
  <official_title>Breathing Techniques and Meditation for Health Care Workers During COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</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 phase I trial investigates breathing techniques and meditation for health care workers&#xD;
      during COVID-19 pandemic. Breathing techniques and medication may help manage stress and&#xD;
      improve lung health. The goal of this trial is to learn if breathing techniques and&#xD;
      meditation may help to reduce stress and improve lung health in health care workers during&#xD;
      the COVID-19 pandemic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. To demonstrate the feasibility of a short pranayama or breathing techniques and meditation&#xD;
      during Covid-19 pandemic.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the adherence to the practice assessed as at least 50% of participants&#xD;
      implement the intervention for 3 or more times in a week by the end of week 1/day 7 (+ 3&#xD;
      days).&#xD;
&#xD;
      II. To determine the change in resilience, perceived stress and psychological impact from day&#xD;
      0 today 28 as measured by the Brief Resilient Coping Scale (BRCS), Perceived Stress Scale&#xD;
      (PSS4), and COVID-19 Stress among health care workers questionnaire.&#xD;
&#xD;
      III. To determine the changes in breath holding time measured weekly for 4 weeks.&#xD;
&#xD;
      IV. To determine the differences in breath holding time between those who are adherent and&#xD;
      those who are not adherent to the practice.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients view an instructional video on breathing techniques and meditation. Patients then&#xD;
      perform breathing techniques over 3 minutes and meditation over 2 minutes twice daily (BID)&#xD;
      for 28 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 17, 2020</start_date>
  <completion_date type="Anticipated">April 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2025</primary_completion_date>
  <phase>Phase 1</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>Number of Participants Recruited to the Study (Feasibility)</measure>
    <time_frame>Within 2 months</time_frame>
    <description>To demonstrate the feasibility of a short pranayama or breathing techniques and meditation during Covid-19 pandemic. Feasibility will be defined as recruitment of 50 participants to the study within 2 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Perceived the Intervention as Useful</measure>
    <time_frame>Week 1 and Week 4</time_frame>
    <description>Defined as more than 50% of participants perceive the intervention as useful. Meditation perception questions were asked such as usefulness, feeling at peace, hopeful, or relaxed, and responses were recorded as strongly agree, agree, neutral, disagree, and strongly disagree at weeks 1 and 4.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Resilience</measure>
    <time_frame>2 years</time_frame>
    <description>Measured by the Brief Resilient Coping Scale among health care workers questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceive Stress and Psychological Impact</measure>
    <time_frame>2 years</time_frame>
    <description>Measured by the Perceived Stress Scale and COVID-19 Stress among health care workers questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breath Holding Time</measure>
    <time_frame>2 years</time_frame>
    <description>Will determine the differences in breath holding time between those who are adherent and those who are not adherent to the practice.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to the Practice</measure>
    <time_frame>2 years</time_frame>
    <description>Will determine the adherence to the practice assessed as at least 50% of participants implement the intervention for 3 or more times in a week by the end of week 1/day 7 (+ 3 days).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>COVID-19 Infection</condition>
  <arm_group>
    <arm_group_label>Supportive Care (video, breathing techniques, meditation)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients view an instructional video on breathing techniques and meditation. Patients then perform breathing techniques over 3 minutes and meditation over 2 minutes BID for 28 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Media Intervention</intervention_name>
    <description>View instructional video</description>
    <arm_group_label>Supportive Care (video, breathing techniques, meditation)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Meditation Therapy</intervention_name>
    <description>Perform meditation</description>
    <arm_group_label>Supportive Care (video, breathing techniques, meditation)</arm_group_label>
    <other_name>Meditation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Supportive Care (video, breathing techniques, meditation)</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Supportive Care (video, breathing techniques, meditation)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Yoga</intervention_name>
    <description>Perform breathing techniques</description>
    <arm_group_label>Supportive Care (video, breathing techniques, meditation)</arm_group_label>
    <other_name>Yoga Therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must be able to read and understand English&#xD;
&#xD;
          -  Must be employed at MD Anderson Cancer Center&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Epilepsy&#xD;
&#xD;
          -  Brain tumor&#xD;
&#xD;
          -  Brain aneurysm&#xD;
&#xD;
          -  Pregnant or trying to get pregnant&#xD;
&#xD;
          -  Brain bleeding in the past 1 year&#xD;
&#xD;
          -  Recent abdominal surgery and not cleared to exercise&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Santhosshi Narayanan</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>M D Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <results_first_submitted>February 1, 2022</results_first_submitted>
  <results_first_submitted_qc>February 11, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">February 16, 2022</results_first_posted>
  <last_update_submitted>April 13, 2023</last_update_submitted>
  <last_update_submitted_qc>April 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 19, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/47/NCT04482647/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The purpose of this study is to determine the effects of web-based breathing techniques and meditation on lung health and building resilience among health care workers dealing with the COVID-19 pandemic.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Supportive Care (Video, Breathing Techniques, Meditation)</title>
          <description>Patients view an instructional video on breathing techniques and meditation. Patients then perform breathing techniques over 3 minutes and meditation over 2 minutes BID for 28 days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="88"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Time constraints</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Health issues</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death in the family</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Disliked the intervention</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No reasons specified</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Supportive Care (Video, Breathing Techniques, Meditation)</title>
          <description>Patients view an instructional video on breathing techniques and meditation. Patients then perform breathing techniques over 3 minutes and meditation over 2 minutes BID for 28 days.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="100"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>26-35 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36-45 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>46-55 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>56-65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Above 66 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Junior/High</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>College</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Masters or higher</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Religion</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Catholic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protestant</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>None</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Occupation</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Clinical role</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Administration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Research</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Recruited to the Study (Feasibility)</title>
        <description>To demonstrate the feasibility of a short pranayama or breathing techniques and meditation during Covid-19 pandemic. Feasibility will be defined as recruitment of 50 participants to the study within 2 months.</description>
        <time_frame>Within 2 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Supportive Care (Video, Breathing Techniques, Meditation)</title>
            <description>Patients view an instructional video on breathing techniques and meditation. Patients then perform breathing techniques over 3 minutes and meditation over 2 minutes BID for 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Recruited to the Study (Feasibility)</title>
          <description>To demonstrate the feasibility of a short pranayama or breathing techniques and meditation during Covid-19 pandemic. Feasibility will be defined as recruitment of 50 participants to the study within 2 months.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Perceived the Intervention as Useful</title>
        <description>Defined as more than 50% of participants perceive the intervention as useful. Meditation perception questions were asked such as usefulness, feeling at peace, hopeful, or relaxed, and responses were recorded as strongly agree, agree, neutral, disagree, and strongly disagree at weeks 1 and 4.</description>
        <time_frame>Week 1 and Week 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Supportive Care (Video, Breathing Techniques, Meditation)</title>
            <description>Patients view an instructional video on breathing techniques and meditation. Patients then perform breathing techniques over 3 minutes and meditation over 2 minutes BID for 28 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Perceived the Intervention as Useful</title>
          <description>Defined as more than 50% of participants perceive the intervention as useful. Meditation perception questions were asked such as usefulness, feeling at peace, hopeful, or relaxed, and responses were recorded as strongly agree, agree, neutral, disagree, and strongly disagree at weeks 1 and 4.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Resilience</title>
        <description>Measured by the Brief Resilient Coping Scale among health care workers questionnaire.</description>
        <time_frame>2 years</time_frame>
        <posting_date>11/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Perceive Stress and Psychological Impact</title>
        <description>Measured by the Perceived Stress Scale and COVID-19 Stress among health care workers questionnaire.</description>
        <time_frame>2 years</time_frame>
        <posting_date>11/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Breath Holding Time</title>
        <description>Will determine the differences in breath holding time between those who are adherent and those who are not adherent to the practice.</description>
        <time_frame>2 years</time_frame>
        <posting_date>11/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adherence to the Practice</title>
        <description>Will determine the adherence to the practice assessed as at least 50% of participants implement the intervention for 3 or more times in a week by the end of week 1/day 7 (+ 3 days).</description>
        <time_frame>2 years</time_frame>
        <posting_date>11/2024</posting_date>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>adverse event data were collected at week 1 and week 4</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Supportive Care (Video, Breathing Techniques, Meditation)</title>
          <description>Patients view an instructional video on breathing techniques and meditation. Patients then perform breathing techniques over 3 minutes and meditation over 2 minutes BID for 28 days.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Reporting Results for Primary Outcome Measures due to the PCD has been met.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Santhosshi Narayanan, MD-Assistant Professor, Integrative Medicine Program</name_or_title>
      <organization>UT MD Anderson Cancer Center</organization>
      <phone>(346) 228-6676</phone>
      <email>snarayanan2@mdanderson.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04482647
org study id: 2020-0483
secondary id: NCI-2020-04931
secondary id: 2020-0483
nct id: NCT04482647
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This phase I trial investigates breathing techniques and meditation for health care workers
      during COVID-19 pandemic. Breathing techniques and medication may help manage stress and
      improve lung health. The goal of this trial is to learn if breathing techniques and
      meditation may help to reduce stress and improve lung health in health care workers during
      the COVID-19 pandemic.
PRIMARY OBJECTIVE:

      I. To demonstrate the feasibility of a short pranayama or breathing techniques and meditation
      during Covid-19 pandemic.

      SECONDARY OBJECTIVES:

      I. To determine the adherence to the practice assessed as at least 50% of participants
      implement the intervention for 3 or more times in a week by the end of week 1/day 7 (+ 3
      days).

      II. To determine the change in resilience, perceived stress and psychological impact from day
      0 today 28 as measured by the Brief Resilient Coping Scale (BRCS), Perceived Stress Scale
      (PSS4), and COVID-19 Stress among health care workers questionnaire.

      III. To determine the changes in breath holding time measured weekly for 4 weeks.

      IV. To determine the differences in breath holding time between those who are adherent and
      those who are not adherent to the practice.

      OUTLINE:

      Patients view an instructional video on breathing techniques and meditation. Patients then
      perform breathing techniques over 3 minutes and meditation over 2 minutes twice daily (BID)
      for 28 days.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of Participants Recruited to the Study (Feasibility)
time frame: Within 2 months
description: To demonstrate the feasibility of a short pranayama or breathing techniques and meditation during Covid-19 pandemic. Feasibility will be defined as recruitment of 50 participants to the study within 2 months.
measure: Number of Participants Who Perceived the Intervention as Useful
time frame: Week 1 and Week 4
description: Defined as more than 50% of participants perceive the intervention as useful. Meditation perception questions were asked such as usefulness, feeling at peace, hopeful, or relaxed, and responses were recorded as strongly agree, agree, neutral, disagree, and strongly disagree at weeks 1 and 4.
measure: Change in Resilience
time frame: 2 years
description: Measured by the Brief Resilient Coping Scale among health care workers questionnaire.
measure: Perceive Stress and Psychological Impact
time frame: 2 years
description: Measured by the Perceived Stress Scale and COVID-19 Stress among health care workers questionnaire.
measure: Breath Holding Time
time frame: 2 years
description: Will determine the differences in breath holding time between those who are adherent and those who are not adherent to the practice.
measure: Adherence to the Practice
time frame: 2 years
description: Will determine the adherence to the practice assessed as at least 50% of participants implement the intervention for 3 or more times in a week by the end of week 1/day 7 (+ 3 days).
arm group label: Supportive Care (video, breathing techniques, meditation)
arm group type: Experimental
description: Patients view an instructional video on breathing techniques and meditation. Patients then perform breathing techniques over 3 minutes and meditation over 2 minutes BID for 28 days.
intervention type: Other
intervention name: Media Intervention
description: View instructional video
arm group label: Supportive Care (video, breathing techniques, meditation)
intervention type: Procedure
intervention name: Meditation Therapy
description: Perform meditation
arm group label: Supportive Care (video, breathing techniques, meditation)
other name: Meditation
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Supportive Care (video, breathing techniques, meditation)
other name: Quality of Life Assessment
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Supportive Care (video, breathing techniques, meditation)
intervention type: Procedure
intervention name: Yoga
description: Perform breathing techniques
arm group label: Supportive Care (video, breathing techniques, meditation)
other name: Yoga Therapy
criteria: 
gender: All
minimum age: N/A
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Santhosshi Narayanan
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: COVID-19
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Reporting Results for Primary Outcome Measures due to the PCD has been met.
point of contact: 