<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/NCT03768102</url>
  </required_header>
  <id_info>
    <org_study_id>SNUMR2-3</org_study_id>
    <nct_id>NCT03768102</nct_id>
  </id_info>
  <brief_title>Comparison of Verbal Rating Scale and Numerical Rating Scale in Post Anesthesia Care Unit</brief_title>
  <official_title>Comparative Study of Verbal Rating Scale and Numerical Rating Scale in Post Anesthesia Care Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the postanesthetic care unit(PACU), patients who are recovering from anesthesia are not&#xD;
      easy to communicate with. Accordingly, accurate evaluation of acute surgical pain is&#xD;
      difficult for PACU patients in spite of severe postoperative pain. Therefore, pain evaluation&#xD;
      is clinically important and challenging in PACU. The pain evaluation tool should be simple&#xD;
      and easy to understand for accurate assessment. Among the most commonly used pain assessment&#xD;
      methods are numerical rating scale(NRS), visual analogue scale(VAS) and verbal rating&#xD;
      scale(VRS). These three methods have proved valid for clinical situations in many studies.&#xD;
      VRS appears to be easier to understand than the other two methods for patients in PACU. The&#xD;
      purpose of this study is to compare NRS and VRS in PACU patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 12, 2018</start_date>
  <completion_date type="Actual">August 30, 2019</completion_date>
  <primary_completion_date type="Actual">August 30, 2019</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>Pain measurement by the numerical rating scale</measure>
    <time_frame>5 minutes after transferred into the postanesthesia care unit</time_frame>
    <description>Patients verbally requested to rate their pain : &quot;Rate your pain from 0 (no pain) to 10 (unbearable pain)&quot;.&#xD;
0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain measurement by the numerical rating scale</measure>
    <time_frame>20 minutes after transferred into the postanesthesia care unit</time_frame>
    <description>Patients verbally requested to rate their pain : &quot;Rate your pain from 0 (no pain) to 10 (unbearable pain)&quot; 0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain measurement by the numerical rating scale</measure>
    <time_frame>40 minutes after transferred into the postanesthesia care unit</time_frame>
    <description>Patients verbally requested to rate their pain : &quot;Rate your pain from 0 (no pain) to 10 (unbearable pain)&quot; 0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain measurement by the verbal rating scale</measure>
    <time_frame>5 minutes after transferred into the postanesthesia care unit</time_frame>
    <description>Patients verbally requested to answer which of the four categories you belong to : no pain, mild pain, moderate pain, severe pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain measurement by the verbal rating scale</measure>
    <time_frame>20 minutes after transferred into the postanesthesia care unit</time_frame>
    <description>Patients verbally requested to answer which of the four categories you belong to : no pain, mild pain, moderate pain, severe pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain measurement by the verbal rating scale</measure>
    <time_frame>40 minutes after transferred into the postanesthesia care unit</time_frame>
    <description>Patients verbally requested to answer which of the four categories you belong to : no pain, mild pain, moderate pain, severe pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>nonresponse rate of the numerical rating scale</measure>
    <time_frame>1 year</time_frame>
    <description>the rate of assessment failures among the total number of assessment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>nonresponse rate of the verbal rating scale</measure>
    <time_frame>1 year</time_frame>
    <description>the rate of assessment failures among the total number of assessment</description>
  </primary_outcome>
  <enrollment type="Actual">200</enrollment>
  <condition>Pain Measurement</condition>
  <condition>Acute Pain</condition>
  <condition>Postoperative Pain</condition>
  <eligibility>
    <study_pop>
      <textblock>
        An adult patient who has been transferred to the recovery room after receiving general&#xD;
        anesthesia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients who underwent general anesthesia&#xD;
&#xD;
          -  The American Society of Anesthesiologists(ASA) physical status classification system :&#xD;
             class 1, 2, 3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The American Society of Anesthesiologists(ASA) physical status classification system :&#xD;
             class 4, 5&#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>Jin-Tae Kim, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jin-Tae Kim</name>
      <address>
        <city>Seoul</city>
        <state>Select</state>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>October 19, 2020</last_update_submitted>
  <last_update_submitted_qc>October 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Jin-Tae Kim</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Pain</mesh_term>
  </condition_browse>
  <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/NCT03768102
org study id: SNUMR2-3
nct id: NCT03768102
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In the postanesthetic care unit(PACU), patients who are recovering from anesthesia are not
      easy to communicate with. Accordingly, accurate evaluation of acute surgical pain is
      difficult for PACU patients in spite of severe postoperative pain. Therefore, pain evaluation
      is clinically important and challenging in PACU. The pain evaluation tool should be simple
      and easy to understand for accurate assessment. Among the most commonly used pain assessment
      methods are numerical rating scale(NRS), visual analogue scale(VAS) and verbal rating
      scale(VRS). These three methods have proved valid for clinical situations in many studies.
      VRS appears to be easier to understand than the other two methods for patients in PACU. The
      purpose of this study is to compare NRS and VRS in PACU patients.
observational model: Cohort
time perspective: Prospective
measure: Pain measurement by the numerical rating scale
time frame: 5 minutes after transferred into the postanesthesia care unit
description: Patients verbally requested to rate their pain : "Rate your pain from 0 (no pain) to 10 (unbearable pain)".
0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.
measure: Pain measurement by the numerical rating scale
time frame: 20 minutes after transferred into the postanesthesia care unit
description: Patients verbally requested to rate their pain : "Rate your pain from 0 (no pain) to 10 (unbearable pain)" 0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.
measure: Pain measurement by the numerical rating scale
time frame: 40 minutes after transferred into the postanesthesia care unit
description: Patients verbally requested to rate their pain : "Rate your pain from 0 (no pain) to 10 (unbearable pain)" 0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.
measure: Pain measurement by the verbal rating scale
time frame: 5 minutes after transferred into the postanesthesia care unit
description: Patients verbally requested to answer which of the four categories you belong to : no pain, mild pain, moderate pain, severe pain
measure: Pain measurement by the verbal rating scale
time frame: 20 minutes after transferred into the postanesthesia care unit
description: Patients verbally requested to answer which of the four categories you belong to : no pain, mild pain, moderate pain, severe pain
measure: Pain measurement by the verbal rating scale
time frame: 40 minutes after transferred into the postanesthesia care unit
description: Patients verbally requested to answer which of the four categories you belong to : no pain, mild pain, moderate pain, severe pain
measure: nonresponse rate of the numerical rating scale
time frame: 1 year
description: the rate of assessment failures among the total number of assessment
measure: nonresponse rate of the verbal rating scale
time frame: 1 year
description: the rate of assessment failures among the total number of assessment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jin-Tae Kim, Ph.D.
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jin-Tae Kim
investigator title: Professor
mesh term: Acute Pain
sharing ipd: No