<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/NCT02243410</url>
  </required_header>
  <id_info>
    <org_study_id>HBK01</org_study_id>
    <nct_id>NCT02243410</nct_id>
  </id_info>
  <brief_title>Visual Analogue Scale - a Quality Assurance Study</brief_title>
  <official_title>Visual Analogue Scale (VAS) - a Quality Assurance Research Study to Assess the Quality of the VAS as a Means for Measuring Postoperative Pain.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Herlev Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Herlev Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It has come to our attention that there is not a general consensus of how to apply Visual&#xD;
      Analogue Scale (VAS) as a tool in measuring pain amongst postoperative patients in Denmark.&#xD;
&#xD;
      The assumption is that patients will grade the level of pain differently dependent on how VAS&#xD;
      is presented.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To ensure the data is valid for the study it has been decided to base the research material&#xD;
      on four different VAS usage, as it is most often used in clinical practise in Denmark. Which&#xD;
      in this case implies VAS horizontal, with and without endpoint, and VAS vertical, with and&#xD;
      without endpoint. Every participant will grade their pain on each of the listed VAS&#xD;
      representations. Furthermore, as a guideline, the participant will be asked to grade the pain&#xD;
      on a Numerical Ranking Scale (NRS).&#xD;
&#xD;
      The ordering of VAS lines will be subject to randomization, for each participant&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</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>agreement in VAS values with horizontal vs vertical and with and without stop lines</measure>
    <time_frame>First five days after surgery</time_frame>
  </primary_outcome>
  <enrollment type="Actual">62</enrollment>
  <condition>Surgery</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All participants will be postoperative patients of Department of Surgery, Department of&#xD;
        Gynecology and Department of Orthopaedic Surgery, all based at Herlev Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient must have undergone surgery within the last five days&#xD;
&#xD;
          -  The patient must be able and willing to participate in the study&#xD;
&#xD;
          -  Must be at 18 years of age or older&#xD;
&#xD;
          -  A patient can only participate one time.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previously included patients&#xD;
&#xD;
          -  Medically treated patients Linguistic difficulties&#xD;
&#xD;
          -  Mentally or physically exhausted&#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>Jacob Rosenberg, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Herlev Hospital</name>
      <address>
        <city>Herlev</city>
        <zip>2730</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <last_update_submitted>September 15, 2014</last_update_submitted>
  <last_update_submitted_qc>September 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 17, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Herlev Hospital</investigator_affiliation>
    <investigator_full_name>Jacob Rosenberg</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT02243410
org study id: HBK01
nct id: NCT02243410
lead sponsor: 
has dmc: No
It has come to our attention that there is not a general consensus of how to apply Visual
      Analogue Scale (VAS) as a tool in measuring pain amongst postoperative patients in Denmark.

      The assumption is that patients will grade the level of pain differently dependent on how VAS
      is presented.
To ensure the data is valid for the study it has been decided to base the research material
      on four different VAS usage, as it is most often used in clinical practise in Denmark. Which
      in this case implies VAS horizontal, with and without endpoint, and VAS vertical, with and
      without endpoint. Every participant will grade their pain on each of the listed VAS
      representations. Furthermore, as a guideline, the participant will be asked to grade the pain
      on a Numerical Ranking Scale (NRS).

      The ordering of VAS lines will be subject to randomization, for each participant
observational model: Cohort
time perspective: Prospective
measure: agreement in VAS values with horizontal vs vertical and with and without stop lines
time frame: First five days after surgery
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jacob Rosenberg, MD
role: Study Chair
affiliation: Professor
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Herlev Hospital
investigator full name: Jacob Rosenberg
investigator title: Professor