<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/NCT04472559</url>
  </required_header>
  <id_info>
    <org_study_id>20-000773</org_study_id>
    <nct_id>NCT04472559</nct_id>
  </id_info>
  <brief_title>Acupressure for COVID-19 Related Quality of Life and Stress</brief_title>
  <official_title>Randomized Controlled Trial of Acupressure for Health-Related Quality of Life and Perception of Stress Among Health Care Providers During the COVID-19 Pandemic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Los Angeles</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 is being conducted to evaluate the efficacy of acupressure in promoting health and&#xD;
      well-being among healthcare workers during the COVID-19 pandemic. The investigators&#xD;
      hypothesize that providing participants with a remote and standardized self-acupressure&#xD;
      training program will improve HRQOL and the perception of stress. In the event that the study&#xD;
      demonstrates acupressure to be safe and effective for this indication, the training could be&#xD;
      scaled up and deployed at low-cost nationally and internationally.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 16, 2021</start_date>
  <completion_date type="Actual">September 1, 2022</completion_date>
  <primary_completion_date type="Actual">June 24, 2022</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Health Related Quality of Life</measure>
    <time_frame>8 weeks</time_frame>
    <description>SF-12v2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perception of stress</measure>
    <time_frame>8 weeks</time_frame>
    <description>Perceived Stress Scale</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">164</enrollment>
  <condition>Quality of Life</condition>
  <condition>Stress</condition>
  <arm_group>
    <arm_group_label>Self-acupressure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Self-acupressure</intervention_name>
    <description>Self-acupressure</description>
    <arm_group_label>Self-acupressure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adult patients (18 years of age and over) who are health care providers according&#xD;
             to self-report will be eligible for participation with the exception of subjects&#xD;
             meeting exclusion criteria as below.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria includes subjects who are physically unable to participate (e.g.,&#xD;
             from severe arthritis) or cognitively unable to participate (e.g., from dementia) will&#xD;
             be excluded. Patients unable to provide their own informed consent will be excluded.&#xD;
             Patients under the age of 18 years will be excluded. Pregnant women will be excluded.&#xD;
             Patients who have previous training in acupressure will be excluded.&#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>Ka-Kit Hui, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCLA</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>October 31, 2022</last_update_submitted>
  <last_update_submitted_qc>October 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Kakit P. Hui, MD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <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/NCT04472559
org study id: 20-000773
nct id: NCT04472559
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is being conducted to evaluate the efficacy of acupressure in promoting health and
      well-being among healthcare workers during the COVID-19 pandemic. The investigators
      hypothesize that providing participants with a remote and standardized self-acupressure
      training program will improve HRQOL and the perception of stress. In the event that the study
      demonstrates acupressure to be safe and effective for this indication, the training could be
      scaled up and deployed at low-cost nationally and internationally.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Health Related Quality of Life
time frame: 8 weeks
description: SF-12v2
measure: Perception of stress
time frame: 8 weeks
description: Perceived Stress Scale
arm group label: Self-acupressure
arm group type: Experimental
arm group label: Control
arm group type: No Intervention
intervention type: Behavioral
intervention name: Self-acupressure
description: Self-acupressure
arm group label: Self-acupressure
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ka-Kit Hui, MD
role: Principal Investigator
affiliation: University of California, Los Angeles
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Kakit P. Hui, MD
investigator title: Professor
sharing ipd: No