<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/NCT04497220</url>
  </required_header>
  <id_info>
    <org_study_id>ANES-2020-29006</org_study_id>
    <nct_id>NCT04497220</nct_id>
  </id_info>
  <brief_title>Poke and a Placebo</brief_title>
  <official_title>Will Negative Phrasing Create a Nocebo Effect During Epidural Placement When Compared to Positive Phrasing? A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Minnesota</source>
  <oversight_info>
    <has_dmc>Yes</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>
      To discover if a positive description of the procedure for an epidural can reduce the overall&#xD;
      pain score associated with the procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study intervention consists of two separate scripts read to the patient by the&#xD;
      anesthesiologist performing their labor epidural. One script will contain the wording &quot;Poke&#xD;
      and a burn&quot; prior to subcutaneous local anesthetic administration for the epidural placement&#xD;
      and one will contain &quot;this is numbing medication, which will make the rest of the procedure&#xD;
      go easier&quot;. There will be no difference in the epidural placement, medications, or the rest&#xD;
      of the script.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 12, 2021</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Max pain score during the epidural procedure</measure>
    <time_frame>1 hour</time_frame>
    <description>Maximum pain score will be measured using a single 11-point Numeric Rating Scale 0-10, where 0 is no pain and 10 is maximum imaginable pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall satisfaction during the epidural procedure</measure>
    <time_frame>1 hour</time_frame>
    <description>Overall satisfaction during the epidural procedure will be measured used a 5-point likert scale: 5=very satisfied, 4=satisfied, 3=neither satisfied or dissatisfied, 2=dissatisfied, 1=very dissatisfied.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Nocebo Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants in this group will receive the control treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Positive Connotation Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group will receive the experimental treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Negative Connotation Langauge</intervention_name>
    <description>The study intervention consists of two separate scripts read to the patient by the anesthesiologist performing their labor epidural. The control script includes language containing the wording &quot;Poke and a burn&quot; said prior to numbing medication for the epidural procedure. There will be no difference in the epidural placement, medications, or the rest of the script.</description>
    <arm_group_label>Nocebo Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Positive Connotation Language</intervention_name>
    <description>The study intervention consists of two separate scripts read to the patient by the anesthesiologist performing their labor epidural. The experimental script includes language containing the wording &quot;this is numbing medication, which will make the rest of the procedure go easier&quot; said prior to numbing medication for the epidural procedure. There will be no difference in the epidural placement, medications, or the rest of the script.</description>
    <arm_group_label>Positive Connotation Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  requesting an epidural for the first time&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous epidural (either for labor or for surgery)&#xD;
&#xD;
          -  BMI greater than 40 kg/m^2&#xD;
&#xD;
          -  previous lumbar spine surgery&#xD;
&#xD;
          -  inability to speak English&#xD;
&#xD;
          -  a history of chronic pain or are on chronic opioids&#xD;
&#xD;
          -  a history of opioid drug abuse&#xD;
      </textblock>
    </criteria>
    <gender>Female</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>Aaron Berg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Aaron Berg, MD</last_name>
    <phone>612-624-9990</phone>
    <email>bergx831@umn.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jonah Pearson, MD</last_name>
    <phone>612-625-6659</phone>
    <email>pears731@umn.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Candace Nelson</last_name>
      <phone>612-626-2465</phone>
      <email>nelso377@umn.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>February 20, 2023</last_update_submitted>
  <last_update_submitted_qc>February 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Epidural Anesthesia (labor)</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/NCT04497220
org study id: ANES-2020-29006
nct id: NCT04497220
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To discover if a positive description of the procedure for an epidural can reduce the overall
      pain score associated with the procedure.
The study intervention consists of two separate scripts read to the patient by the
      anesthesiologist performing their labor epidural. One script will contain the wording "Poke
      and a burn" prior to subcutaneous local anesthetic administration for the epidural placement
      and one will contain "this is numbing medication, which will make the rest of the procedure
      go easier". There will be no difference in the epidural placement, medications, or the rest
      of the script.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Max pain score during the epidural procedure
time frame: 1 hour
description: Maximum pain score will be measured using a single 11-point Numeric Rating Scale 0-10, where 0 is no pain and 10 is maximum imaginable pain.
measure: Overall satisfaction during the epidural procedure
time frame: 1 hour
description: Overall satisfaction during the epidural procedure will be measured used a 5-point likert scale: 5=very satisfied, 4=satisfied, 3=neither satisfied or dissatisfied, 2=dissatisfied, 1=very dissatisfied.
arm group label: Nocebo Group
arm group type: Placebo Comparator
description: Participants in this group will receive the control treatment
arm group label: Positive Connotation Group
arm group type: Experimental
description: Participants in this group will receive the experimental treatment.
intervention type: Behavioral
intervention name: Negative Connotation Langauge
description: The study intervention consists of two separate scripts read to the patient by the anesthesiologist performing their labor epidural. The control script includes language containing the wording "Poke and a burn" said prior to numbing medication for the epidural procedure. There will be no difference in the epidural placement, medications, or the rest of the script.
arm group label: Nocebo Group
intervention type: Behavioral
intervention name: Positive Connotation Language
description: The study intervention consists of two separate scripts read to the patient by the anesthesiologist performing their labor epidural. The experimental script includes language containing the wording "this is numbing medication, which will make the rest of the procedure go easier" said prior to numbing medication for the epidural procedure. There will be no difference in the epidural placement, medications, or the rest of the script.
arm group label: Positive Connotation Group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Aaron Berg, MD
role: Principal Investigator
affiliation: University of Minnesota
last name: Aaron Berg, MD
phone: 612-624-9990
email: bergx831@umn.edu
last name: Jonah Pearson, MD
phone: 612-625-6659
email: pears731@umn.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor