<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/NCT03245034</url>
  </required_header>
  <id_info>
    <org_study_id>16-02292</org_study_id>
    <nct_id>NCT03245034</nct_id>
  </id_info>
  <brief_title>Assessing the Impact of Acupuncture Therapy on Medical Resident Well-Being: Feasibility and Acceptance</brief_title>
  <official_title>Assessing the Impact of Acupuncture Therapy on Medical Resident Well-Being: Feasibility and Acceptance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</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 feasibility study develops methods for larger-scale research, evaluating the&#xD;
      acceptability and perceived impact of a group acupuncture and acupressure intervention, as&#xD;
      well as suitability of a self-report instrument. During their weekly training program, eleven&#xD;
      OB residents at NYU Lutheran Medical Center will receive three sessions of auricular&#xD;
      acupuncture therapy. (This resident population was previously anonymously surveyed and all&#xD;
      expressed interest in participating in such a study). The Professional Quality of Life Scale&#xD;
      (ProQOL) will be administered at 6 time points. A brief survey will also be given to assess&#xD;
      participants' acceptance of the intervention as well as applicability of the ProQOL&#xD;
      instrument. Additional feasibility-related outcomes include protocol compliance/withdrawals,&#xD;
      adverse events, and time taken to complete intervention and surveys.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Actual">September 1, 2017</completion_date>
  <primary_completion_date type="Actual">September 1, 2017</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Professional Quality of Life (ProQOL)</measure>
    <time_frame>4 Weeks</time_frame>
    <description>he ProQOL is the most commonly used measure of the negative and positive affects of helping others who experience suffering and trauma. The ProQOL has sub-scales for compassion satisfaction, burnout and compassion fatigue.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Exhaustion; Syndrome</condition>
  <arm_group>
    <arm_group_label>fourth-year Obstetrics and Gynecology residents</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention will be three sessions of auricular acupuncture therapy; there will be no control intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Auricular Acupuncture Therapy</intervention_name>
    <description>Acupuncture treatment will be the NADA protocol, a well-known and commonly used protocol that has previously been studied for stress relief in health care workers.In this protocol, 5, ½&quot; needles are inserted in each auricle and retained while the group relaxes for 20 minutes. It will be conducted by two acupuncturists credentialed at NYU Lutheran (TK and AG).</description>
    <arm_group_label>fourth-year Obstetrics and Gynecology residents</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Enrollment in NYU Lutheran Obstetrics &amp; Gynecology Residency program&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women currently pregnant or attempting to conceive&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>44 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Meera Kesavan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York University School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>October 6, 2017</last_update_submitted>
  <last_update_submitted_qc>October 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Medical Residents</keyword>
  <keyword>Well-Being</keyword>
  <keyword>Stress/Burnout in Medical Residents</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03245034
org study id: 16-02292
nct id: NCT03245034
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This feasibility study develops methods for larger-scale research, evaluating the
      acceptability and perceived impact of a group acupuncture and acupressure intervention, as
      well as suitability of a self-report instrument. During their weekly training program, eleven
      OB residents at NYU Lutheran Medical Center will receive three sessions of auricular
      acupuncture therapy. (This resident population was previously anonymously surveyed and all
      expressed interest in participating in such a study). The Professional Quality of Life Scale
      (ProQOL) will be administered at 6 time points. A brief survey will also be given to assess
      participants' acceptance of the intervention as well as applicability of the ProQOL
      instrument. Additional feasibility-related outcomes include protocol compliance/withdrawals,
      adverse events, and time taken to complete intervention and surveys.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Professional Quality of Life (ProQOL)
time frame: 4 Weeks
description: he ProQOL is the most commonly used measure of the negative and positive affects of helping others who experience suffering and trauma. The ProQOL has sub-scales for compassion satisfaction, burnout and compassion fatigue.
arm group label: fourth-year Obstetrics and Gynecology residents
arm group type: Experimental
description: The intervention will be three sessions of auricular acupuncture therapy; there will be no control intervention.
intervention type: Behavioral
intervention name: Auricular Acupuncture Therapy
description: Acupuncture treatment will be the NADA protocol, a well-known and commonly used protocol that has previously been studied for stress relief in health care workers.In this protocol, 5, ½" needles are inserted in each auricle and retained while the group relaxes for 20 minutes. It will be conducted by two acupuncturists credentialed at NYU Lutheran (TK and AG).
arm group label: fourth-year Obstetrics and Gynecology residents
criteria: 
gender: All
minimum age: 25 Years
maximum age: 44 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Meera Kesavan, MD
role: Principal Investigator
affiliation: NYU Langone Health
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Undecided