<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/NCT04431297</url>
  </required_header>
  <id_info>
    <org_study_id>GCO 20-1022</org_study_id>
    <nct_id>NCT04431297</nct_id>
  </id_info>
  <brief_title>Virtual Mindfulness Rounds in the Time of COVID-19 Pandemic</brief_title>
  <official_title>The Impact of Virtual Mindfulness Education Sessions on Staff Perceived Stress During COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Icahn School of Medicine at Mount Sinai</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>
      Mindfulness education will be provided via a virtual platform to see if staff stress can be&#xD;
      decreased during this time of pandemic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Healthcare workers have been front and center in battling the COVID crisis. This is a&#xD;
      situation the researchers could never have envisioned before it happened. Of course, this has&#xD;
      triggered an inordinate amount of stress. Research shows that chronic stress leaves one&#xD;
      imbalanced and one's health and happiness to suffer. Research has also demonstrated that how&#xD;
      one thinks about stress determines how the body responds to it. Simple mindfulness practices&#xD;
      provide healthier ways to deal with stress. In this study, the researchers will introduce&#xD;
      modified mindfulness practices that can be practiced in the healthcare setting or at home.&#xD;
      All of the practices are based on mindfulness principles. Mindfulness refers to a state of&#xD;
      being present in the moment, on purpose, and without judgment. &quot;Mindfulness Based Stress&#xD;
      Reduction&quot; is an 8 week, 2 hours/week curriculum that has shown results for over 40 years.&#xD;
      All the practices in this study are adapted from that protocol.&#xD;
&#xD;
      The intervention includes several mindfulness practices including an awareness of breath&#xD;
      focus instruction, breath-and-body coordination and awareness instruction, and instruction in&#xD;
      identifying times to practice these exercises. The intervention will be delivered virtually&#xD;
      2-day/week, twice/day, for four weeks.&#xD;
&#xD;
      Effectiveness will be measured by the voluntary, anonymous submission of a Perceived Stress&#xD;
      Scale, a validated survey tool to determine an individual's perceived stress level.&#xD;
&#xD;
      Participants will be healthcare workers and hospital staff in the Mount Sinai Hospital&#xD;
      system.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 22, 2021</start_date>
  <completion_date type="Actual">May 14, 2021</completion_date>
  <primary_completion_date type="Actual">May 14, 2021</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>Change in Perceived Stress Scale</measure>
    <time_frame>baseline and Week 6</time_frame>
    <description>Participants will file a 10 question validated survey tool call the Perceived Stress Scale (PSS) before and after the 4-week virtual educational intervention. Total scale range from 0 to 40, higher score indicates more perceived stress</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Chronic Stress</condition>
  <arm_group>
    <arm_group_label>Health Care Workers</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Voluntary participation in the virtual presentations</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mindfulness Rounds</intervention_name>
    <description>Virtually delivered mindfulness education sessions of 15-30 minutes, two times/week, for four weeks</description>
    <arm_group_label>Health Care Workers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mount Sinai Hospital employee&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#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>Jeffrey Zahn, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>August 19, 2021</last_update_submitted>
  <last_update_submitted_qc>August 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Icahn School of Medicine at Mount Sinai</investigator_affiliation>
    <investigator_full_name>Jeffrey Zahn</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Stress mindfulness</keyword>
  <!-- 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/NCT04431297
org study id: GCO 20-1022
nct id: NCT04431297
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Mindfulness education will be provided via a virtual platform to see if staff stress can be
      decreased during this time of pandemic.
Healthcare workers have been front and center in battling the COVID crisis. This is a
      situation the researchers could never have envisioned before it happened. Of course, this has
      triggered an inordinate amount of stress. Research shows that chronic stress leaves one
      imbalanced and one's health and happiness to suffer. Research has also demonstrated that how
      one thinks about stress determines how the body responds to it. Simple mindfulness practices
      provide healthier ways to deal with stress. In this study, the researchers will introduce
      modified mindfulness practices that can be practiced in the healthcare setting or at home.
      All of the practices are based on mindfulness principles. Mindfulness refers to a state of
      being present in the moment, on purpose, and without judgment. "Mindfulness Based Stress
      Reduction" is an 8 week, 2 hours/week curriculum that has shown results for over 40 years.
      All the practices in this study are adapted from that protocol.

      The intervention includes several mindfulness practices including an awareness of breath
      focus instruction, breath-and-body coordination and awareness instruction, and instruction in
      identifying times to practice these exercises. The intervention will be delivered virtually
      2-day/week, twice/day, for four weeks.

      Effectiveness will be measured by the voluntary, anonymous submission of a Perceived Stress
      Scale, a validated survey tool to determine an individual's perceived stress level.

      Participants will be healthcare workers and hospital staff in the Mount Sinai Hospital
      system.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in Perceived Stress Scale
time frame: baseline and Week 6
description: Participants will file a 10 question validated survey tool call the Perceived Stress Scale (PSS) before and after the 4-week virtual educational intervention. Total scale range from 0 to 40, higher score indicates more perceived stress
arm group label: Health Care Workers
arm group type: Other
description: Voluntary participation in the virtual presentations
intervention type: Other
intervention name: Mindfulness Rounds
description: Virtually delivered mindfulness education sessions of 15-30 minutes, two times/week, for four weeks
arm group label: Health Care Workers
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jeffrey Zahn, MD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Icahn School of Medicine at Mount Sinai
investigator full name: Jeffrey Zahn
investigator title: Assistant Professor