<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/NCT03764046</url>
  </required_header>
  <id_info>
    <org_study_id>SNUMR2-2</org_study_id>
    <nct_id>NCT03764046</nct_id>
  </id_info>
  <brief_title>Development and Validation of New &quot;SNU Illustrated Pain Rating Scale&quot; as a Tool for Postoperative Pain Assessment</brief_title>
  <official_title>Development and Validation of New &quot;SNU Illustrated Pain Rating Scale&quot; for Effective Assessment of Acute Postoperative Pain: a Comparative Study With Numeric Rating Scale</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>
    <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>
      The numeric rating scale (NRS), one of the most widely used pain scales in clinical practice,&#xD;
      although convenient, is often subject to bias because it requires abstract thinking from both&#xD;
      the patient and the evaluator. Compared to numbers, traumatic pain, when visualized&#xD;
      appropriately, has potential advantage as a means to indicate and communicate the severity of&#xD;
      pain. Given that they are standardized in terms of body parts, wound size, and bleeding&#xD;
      volume, illustrations of traumatic pain along with external somatic stimuli that caused it&#xD;
      can be used to serve as effective visual anchors to supplement a pain scale by giving more&#xD;
      concrete information to the patient. The purpose of this study is to develop Seoul National&#xD;
      University Illustrated Pain Scale(SNUIPS) using pictures of traumatic pain, and verify the&#xD;
      validity and effectiveness of this scale in comparison with those of NRS.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">October 31, 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>Postoperative Pain Scores (NRS)</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>Self-reported pain intensity based on numeric rating scale evaluated after 24 hours after surgery. Each item is scored from 0 to 10 (0 = no pain; 10 = worst imaginable pain). Retrospective assessment of peak postoperative pain intensity will be included in addition to evaluation of current pain intensity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative Pain Scores (NRS)</measure>
    <time_frame>24.5 hours after surgery</time_frame>
    <description>Self-reported pain intensity based on numeric rating scale evaluated after 24.5 hours after surgery for validation in terms of test-retest reliability of the scale. Each item is scored from 0 to 10 (0 = no pain; 10 = worst imaginable pain). Retrospective assessment of peak postoperative pain intensity will be included in addition to evaluation of current pain intensity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative Pain Scores (NRS)</measure>
    <time_frame>48 hours after surgery</time_frame>
    <description>Self-reported pain intensity based on numeric rating scale evaluated after 48 hours after surgery for assessment of sensitivity to change. Each item is scored from 0 to 10 (0 = no pain; 10 = worst imaginable pain).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative Pain Scores (SNUIPS)</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>Self-reported pain intensity based on Seoul National University Illustrated Pain Scale evaluated after 24 hours after surgery. Each item is scored using illustrations that corresponds to 0-10 levels of traumatic pain, beginning from 'no injury and/or pain' to 'causalgia'. Retrospective assessment of peak postoperative pain intensity will be included in addition to evaluation of current pain intensity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative Pain Scores (SNUIPS)</measure>
    <time_frame>24.5 hours after surgery</time_frame>
    <description>Self-reported pain intensity based on Seoul National University Illustrated Pain Scale evaluated after 24.5 hours after surgery. Each item is scored using illustrations that corresponds to 0-10 levels of traumatic pain, beginning from 'no injury and/or pain' to 'causalgia'. Retrospective assessment of peak postoperative pain intensity will be included in addition to evaluation of current pain intensity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative Pain Scores (SNUIPS)</measure>
    <time_frame>48 hours after surgery</time_frame>
    <description>Self-reported pain intensity based on Seoul National University Illustrated Pain Scale evaluated after 48 hours after surgery. Each item is scored using illustrations that corresponds to 0-10 levels of traumatic pain, beginning from 'no injury and/or pain' to 'causalgia'.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative Consumption of Patient-Controlled and/or Rescue Analgesics</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>Amount of analgesics consumed through intravenous patient-controlled analgesia and/or administration of rescue analgesics</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative Consumption of Patient-Controlled and/or Rescue Analgesics</measure>
    <time_frame>24.5 hours after surgery</time_frame>
    <description>Amount of analgesics consumed through intravenous patient-controlled analgesia and/or administration of rescue analgesics</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative Consumption of Patient-Controlled and/or Rescue Analgesics</measure>
    <time_frame>48 hours after surgery</time_frame>
    <description>Amount of analgesics consumed through intravenous patient-controlled analgesia and/or administration of rescue analgesics</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Understandability of Pain Scales</measure>
    <time_frame>48 hours after surgery</time_frame>
    <description>Survey among patients on understandability pain scales</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Convenience of Pain Scales</measure>
    <time_frame>48 hours after surgery</time_frame>
    <description>Survey among patients on convenience of pain scales</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Satisfaction of Postoperative Pain Management</measure>
    <time_frame>48 hours after surgery</time_frame>
    <description>Survey among patients on their level of overall satisfaction on postoperative pain management</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Pain Measurement</condition>
  <condition>Acute Pain</condition>
  <condition>Postoperative Pain</condition>
  <condition>Anesthesia</condition>
  <condition>Surgery</condition>
  <eligibility>
    <study_pop>
      <textblock>
        100 adult patients undergoing postoperative pain control after a gynecological or&#xD;
        orthopedic surgery at Seoul National University Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients undergoing a gynecological or orthopedic surgery under general&#xD;
             anesthesia&#xD;
&#xD;
          -  Administered with intravenous patient-controlled analgesia for postoperative pain&#xD;
             control&#xD;
&#xD;
          -  American Society of Anesthesiologists physical status class I-III patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindicated against fentanyl&#xD;
&#xD;
          -  Unable to communicate&#xD;
&#xD;
          -  Aged less than 18, or more than 79&#xD;
&#xD;
          -  Weighs less than 40kg or more than 89kg&#xD;
&#xD;
          -  Has severe heart disease(s)&#xD;
&#xD;
          -  Pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jin-Tae Kim</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jin-Tae Kim, MD, PhD</last_name>
    <phone>+82-2-2072-3664</phone>
    <email>jintae73@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct;27(1):117-126. doi: 10.1016/0304-3959(86)90228-9.</citation>
    <PMID>3785962</PMID>
  </reference>
  <reference>
    <citation>Breivik H, Borchgrevink PC, Allen SM, Rosseland LA, Romundstad L, Hals EK, Kvarstein G, Stubhaug A. Assessment of pain. Br J Anaesth. 2008 Jul;101(1):17-24. doi: 10.1093/bja/aen103. Epub 2008 May 16.</citation>
    <PMID>18487245</PMID>
  </reference>
  <reference>
    <citation>Karcioglu O, Topacoglu H, Dikme O, Dikme O. A systematic review of the pain scales in adults: Which to use? Am J Emerg Med. 2018 Apr;36(4):707-714. doi: 10.1016/j.ajem.2018.01.008. Epub 2018 Jan 6.</citation>
    <PMID>29321111</PMID>
  </reference>
  <reference>
    <citation>Pathak A, Sharma S, Jensen MP. The utility and validity of pain intensity rating scales for use in developing countries. Pain Rep. 2018 Aug 6;3(5):e672. doi: 10.1097/PR9.0000000000000672. eCollection 2018 Sep-Oct.</citation>
    <PMID>30534623</PMID>
  </reference>
  <reference>
    <citation>Eriksson K, Wikstrom L, Arestedt K, Fridlund B, Brostrom A. Numeric rating scale: patients' perceptions of its use in postoperative pain assessments. Appl Nurs Res. 2014 Feb;27(1):41-6. doi: 10.1016/j.apnr.2013.10.006. Epub 2013 Oct 31.</citation>
    <PMID>24332467</PMID>
  </reference>
  <reference>
    <citation>Noble B, Clark D, Meldrum M, ten Have H, Seymour J, Winslow M, Paz S. The measurement of pain, 1945-2000. J Pain Symptom Manage. 2005 Jan;29(1):14-21. doi: 10.1016/j.jpainsymman.2004.08.007.</citation>
    <PMID>15652435</PMID>
  </reference>
  <reference>
    <citation>Bond MR, Pilowsky I. Subjective assessment of pain and its relationship to the administration of analgesics in patients with advanced cancer. J Psychosom Res. 1966 Sep;10(2):203-8. doi: 10.1016/0022-3999(66)90064-x. No abstract available.</citation>
    <PMID>4165548</PMID>
  </reference>
  <reference>
    <citation>Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.</citation>
    <PMID>4139420</PMID>
  </reference>
  <reference>
    <citation>Bodian CA, Freedman G, Hossain S, Eisenkraft JB, Beilin Y. The visual analog scale for pain: clinical significance in postoperative patients. Anesthesiology. 2001 Dec;95(6):1356-61. doi: 10.1097/00000542-200112000-00013.</citation>
    <PMID>11748392</PMID>
  </reference>
  <reference>
    <citation>Katz J, Melzack R. Measurement of pain. Surg Clin North Am. 1999 Apr;79(2):231-52. doi: 10.1016/s0039-6109(05)70381-9.</citation>
    <PMID>10352653</PMID>
  </reference>
  <reference>
    <citation>Singer T, Seymour B, O'Doherty J, Kaube H, Dolan RJ, Frith CD. Empathy for pain involves the affective but not sensory components of pain. Science. 2004 Feb 20;303(5661):1157-62. doi: 10.1126/science.1093535.</citation>
    <PMID>14976305</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>December 3, 2018</last_update_submitted>
  <last_update_submitted_qc>December 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 2018</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>
  <keyword>Pain Measurement</keyword>
  <keyword>Acute Postoperative Pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</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/NCT03764046
org study id: SNUMR2-2
nct id: NCT03764046
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The numeric rating scale (NRS), one of the most widely used pain scales in clinical practice,
      although convenient, is often subject to bias because it requires abstract thinking from both
      the patient and the evaluator. Compared to numbers, traumatic pain, when visualized
      appropriately, has potential advantage as a means to indicate and communicate the severity of
      pain. Given that they are standardized in terms of body parts, wound size, and bleeding
      volume, illustrations of traumatic pain along with external somatic stimuli that caused it
      can be used to serve as effective visual anchors to supplement a pain scale by giving more
      concrete information to the patient. The purpose of this study is to develop Seoul National
      University Illustrated Pain Scale(SNUIPS) using pictures of traumatic pain, and verify the
      validity and effectiveness of this scale in comparison with those of NRS.
observational model: Cohort
time perspective: Prospective
measure: Postoperative Pain Scores (NRS)
time frame: 24 hours after surgery
description: Self-reported pain intensity based on numeric rating scale evaluated after 24 hours after surgery. Each item is scored from 0 to 10 (0 = no pain; 10 = worst imaginable pain). Retrospective assessment of peak postoperative pain intensity will be included in addition to evaluation of current pain intensity.
measure: Postoperative Pain Scores (NRS)
time frame: 24.5 hours after surgery
description: Self-reported pain intensity based on numeric rating scale evaluated after 24.5 hours after surgery for validation in terms of test-retest reliability of the scale. Each item is scored from 0 to 10 (0 = no pain; 10 = worst imaginable pain). Retrospective assessment of peak postoperative pain intensity will be included in addition to evaluation of current pain intensity.
measure: Postoperative Pain Scores (NRS)
time frame: 48 hours after surgery
description: Self-reported pain intensity based on numeric rating scale evaluated after 48 hours after surgery for assessment of sensitivity to change. Each item is scored from 0 to 10 (0 = no pain; 10 = worst imaginable pain).
measure: Postoperative Pain Scores (SNUIPS)
time frame: 24 hours after surgery
description: Self-reported pain intensity based on Seoul National University Illustrated Pain Scale evaluated after 24 hours after surgery. Each item is scored using illustrations that corresponds to 0-10 levels of traumatic pain, beginning from 'no injury and/or pain' to 'causalgia'. Retrospective assessment of peak postoperative pain intensity will be included in addition to evaluation of current pain intensity.
measure: Postoperative Pain Scores (SNUIPS)
time frame: 24.5 hours after surgery
description: Self-reported pain intensity based on Seoul National University Illustrated Pain Scale evaluated after 24.5 hours after surgery. Each item is scored using illustrations that corresponds to 0-10 levels of traumatic pain, beginning from 'no injury and/or pain' to 'causalgia'. Retrospective assessment of peak postoperative pain intensity will be included in addition to evaluation of current pain intensity.
measure: Postoperative Pain Scores (SNUIPS)
time frame: 48 hours after surgery
description: Self-reported pain intensity based on Seoul National University Illustrated Pain Scale evaluated after 48 hours after surgery. Each item is scored using illustrations that corresponds to 0-10 levels of traumatic pain, beginning from 'no injury and/or pain' to 'causalgia'.
measure: Postoperative Consumption of Patient-Controlled and/or Rescue Analgesics
time frame: 24 hours after surgery
description: Amount of analgesics consumed through intravenous patient-controlled analgesia and/or administration of rescue analgesics
measure: Postoperative Consumption of Patient-Controlled and/or Rescue Analgesics
time frame: 24.5 hours after surgery
description: Amount of analgesics consumed through intravenous patient-controlled analgesia and/or administration of rescue analgesics
measure: Postoperative Consumption of Patient-Controlled and/or Rescue Analgesics
time frame: 48 hours after surgery
description: Amount of analgesics consumed through intravenous patient-controlled analgesia and/or administration of rescue analgesics
measure: Understandability of Pain Scales
time frame: 48 hours after surgery
description: Survey among patients on understandability pain scales
measure: Convenience of Pain Scales
time frame: 48 hours after surgery
description: Survey among patients on convenience of pain scales
measure: Patient Satisfaction of Postoperative Pain Management
time frame: 48 hours after surgery
description: Survey among patients on their level of overall satisfaction on postoperative pain management
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 79 Years
healthy volunteers: No
last name: Jin-Tae Kim
role: Principal Investigator
affiliation: Seoul National University Hospital
last name: Jin-Tae Kim, MD, PhD
phone: +82-2-2072-3664
email: jintae73@gmail.com
facility: 
country: Korea, Republic of
citation: Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct;27(1):117-126. doi: 10.1016/0304-3959(86)90228-9.
PMID: 3785962
citation: Breivik H, Borchgrevink PC, Allen SM, Rosseland LA, Romundstad L, Hals EK, Kvarstein G, Stubhaug A. Assessment of pain. Br J Anaesth. 2008 Jul;101(1):17-24. doi: 10.1093/bja/aen103. Epub 2008 May 16.
PMID: 18487245
citation: Karcioglu O, Topacoglu H, Dikme O, Dikme O. A systematic review of the pain scales in adults: Which to use? Am J Emerg Med. 2018 Apr;36(4):707-714. doi: 10.1016/j.ajem.2018.01.008. Epub 2018 Jan 6.
PMID: 29321111
citation: Pathak A, Sharma S, Jensen MP. The utility and validity of pain intensity rating scales for use in developing countries. Pain Rep. 2018 Aug 6;3(5):e672. doi: 10.1097/PR9.0000000000000672. eCollection 2018 Sep-Oct.
PMID: 30534623
citation: Eriksson K, Wikstrom L, Arestedt K, Fridlund B, Brostrom A. Numeric rating scale: patients' perceptions of its use in postoperative pain assessments. Appl Nurs Res. 2014 Feb;27(1):41-6. doi: 10.1016/j.apnr.2013.10.006. Epub 2013 Oct 31.
PMID: 24332467
citation: Noble B, Clark D, Meldrum M, ten Have H, Seymour J, Winslow M, Paz S. The measurement of pain, 1945-2000. J Pain Symptom Manage. 2005 Jan;29(1):14-21. doi: 10.1016/j.jpainsymman.2004.08.007.
PMID: 15652435
citation: Bond MR, Pilowsky I. Subjective assessment of pain and its relationship to the administration of analgesics in patients with advanced cancer. J Psychosom Res. 1966 Sep;10(2):203-8. doi: 10.1016/0022-3999(66)90064-x. No abstract available.
PMID: 4165548
citation: Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.
PMID: 4139420
citation: Bodian CA, Freedman G, Hossain S, Eisenkraft JB, Beilin Y. The visual analog scale for pain: clinical significance in postoperative patients. Anesthesiology. 2001 Dec;95(6):1356-61. doi: 10.1097/00000542-200112000-00013.
PMID: 11748392
citation: Katz J, Melzack R. Measurement of pain. Surg Clin North Am. 1999 Apr;79(2):231-52. doi: 10.1016/s0039-6109(05)70381-9.
PMID: 10352653
citation: Singer T, Seymour B, O'Doherty J, Kaube H, Dolan RJ, Frith CD. Empathy for pain involves the affective but not sensory components of pain. Science. 2004 Feb 20;303(5661):1157-62. doi: 10.1126/science.1093535.
PMID: 14976305
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jin-Tae Kim
investigator title: Professor
mesh term: Pain, Postoperative
mesh term: Acute Pain