<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/NCT01723137</url>
  </required_header>
  <id_info>
    <org_study_id>10-3189</org_study_id>
    <nct_id>NCT01723137</nct_id>
  </id_info>
  <brief_title>Measuring Changes in Acute Pain in the Emergency Department Using Patient Reported Scales</brief_title>
  <official_title>Measuring Changes in Acute Pain in the Emergency Department Using Patient Reported Scales</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hennepin Healthcare Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hennepin Healthcare Research Institute</source>
  <brief_summary>
    <textblock>
      Patient reported pain, stress, and anxiety measures have been found to be inter-related, but&#xD;
      it is not known if they are all associated with receiving opiate medications. The objective&#xD;
      of this study is to determine if patients' degree of reported pain, stress, or anxiety is&#xD;
      associated with receiving opiate pain medications in the emergency department or at&#xD;
      discharge. Alert patients at least 18 years of age and who report pain greater than 3/10 are&#xD;
      eligible to participate in the study. Consenting patients complete Visual Analog Scales&#xD;
      describing their perceived pain, stress, and anxiety from enrollment until discharge.&#xD;
      Demographic data and administration of pain medication is also recorded. Visual Analog Scale&#xD;
      scores among patients who received an opioid pain medicine in the emergency department and at&#xD;
      discharge will be compared to those who did not.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2010</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Patient Described Stress</measure>
    <time_frame>Immediately upon enrollment, every 30 minutes after until hospital discharge, and upon discharge, for up to 24 hours.</time_frame>
    <description>Patients describe stress by completion of 100 mm Visual Analog Scale, bordered by the words &quot;no stress&quot; and &quot;most stress possible&quot;.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Patient described anxiety.</measure>
    <time_frame>Immediately upon study enrollment, every 30 minutes post-enrollment, and upon hospital discharge, for up to 24 hours.</time_frame>
    <description>Patients describe anxiety by completing 100mm Visual Analog Scale, bordered by the words &quot;no anxiety&quot; and &quot;most anxiety possible&quot;.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in patient described satisfaction with ongoing treatment.</measure>
    <time_frame>Immeditately upon enrollment, every 30 minutes post-enrollment, and upon hospital discharge, up to 24 hours.</time_frame>
    <description>Patients describe satisfaction with ongoing treatment by completion of 100mm Visual Analog Scale, bordered by the words &quot;not satisfied at all&quot; and &quot;completely satisfied&quot;.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in patient described pain.</measure>
    <time_frame>Immediately upon enrollment, every 30 minutes post-enrollment, and upon discharge, for up to 24 hours.</time_frame>
    <description>Patients describe pain by completing a 100mm Visual Analog Scale, bordered by the words &quot;no pain&quot; and &quot;worst pain possible&quot;.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">3630</enrollment>
  <condition>Acute Pain</condition>
  <arm_group>
    <arm_group_label>In pain</arm_group_label>
    <description>Patients who report pain greater than or equal to 3 out of 10 are eligible for this study.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients presenting to the emergency department at an urban county hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Reported pain greater than or equal to 3 out of 10&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 18 years of age&#xD;
&#xD;
          -  Decreased level of consciousness&#xD;
&#xD;
          -  Inability to answer questions&#xD;
&#xD;
          -  Prisoner&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James R Miner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hennepin Healthcare Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hennepin County Medical Center</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55415</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2013</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <last_update_submitted>October 24, 2013</last_update_submitted>
  <last_update_submitted_qc>October 24, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 25, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pain</keyword>
  <keyword>Pain measurement</keyword>
  <keyword>Visual analog scale</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Stress</keyword>
  <keyword>Opioid</keyword>
  <keyword>Emergency department</keyword>
  <keyword>Demographics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Acute Pain</mesh_term>
  </condition_browse>
  <!-- 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/NCT01723137
org study id: 10-3189
nct id: NCT01723137
lead sponsor: 
Patient reported pain, stress, and anxiety measures have been found to be inter-related, but
      it is not known if they are all associated with receiving opiate medications. The objective
      of this study is to determine if patients' degree of reported pain, stress, or anxiety is
      associated with receiving opiate pain medications in the emergency department or at
      discharge. Alert patients at least 18 years of age and who report pain greater than 3/10 are
      eligible to participate in the study. Consenting patients complete Visual Analog Scales
      describing their perceived pain, stress, and anxiety from enrollment until discharge.
      Demographic data and administration of pain medication is also recorded. Visual Analog Scale
      scores among patients who received an opioid pain medicine in the emergency department and at
      discharge will be compared to those who did not.
observational model: Cohort
time perspective: Prospective
measure: Change in Patient Described Stress
time frame: Immediately upon enrollment, every 30 minutes after until hospital discharge, and upon discharge, for up to 24 hours.
description: Patients describe stress by completion of 100 mm Visual Analog Scale, bordered by the words "no stress" and "most stress possible".
measure: Change in Patient described anxiety.
time frame: Immediately upon study enrollment, every 30 minutes post-enrollment, and upon hospital discharge, for up to 24 hours.
description: Patients describe anxiety by completing 100mm Visual Analog Scale, bordered by the words "no anxiety" and "most anxiety possible".
measure: Change in patient described satisfaction with ongoing treatment.
time frame: Immeditately upon enrollment, every 30 minutes post-enrollment, and upon hospital discharge, up to 24 hours.
description: Patients describe satisfaction with ongoing treatment by completion of 100mm Visual Analog Scale, bordered by the words "not satisfied at all" and "completely satisfied".
measure: Change in patient described pain.
time frame: Immediately upon enrollment, every 30 minutes post-enrollment, and upon discharge, for up to 24 hours.
description: Patients describe pain by completing a 100mm Visual Analog Scale, bordered by the words "no pain" and "worst pain possible".
arm group label: In pain
description: Patients who report pain greater than or equal to 3 out of 10 are eligible for this study.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: James R Miner, MD
role: Principal Investigator
affiliation: Hennepin Healthcare Research Institute
facility: 
country: United States
responsible party type: Sponsor
mesh term: Emergencies
mesh term: Acute Pain