Development and Validation of New "SNU Illustrated Pain Rating Scale" as a Tool for Postoperative Pain Assessment

Sponsor
Seoul National University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03764046
Collaborator
(none)
100
1
12
8.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Development and Validation of New "SNU Illustrated Pain Rating Scale" for Effective Assessment of Acute Postoperative Pain: a Comparative Study With Numeric Rating Scale
    Anticipated Study Start Date :
    Jan 1, 2019
    Anticipated Primary Completion Date :
    Oct 31, 2019
    Anticipated Study Completion Date :
    Dec 31, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Postoperative Pain Scores (NRS) [24 hours after surgery]

      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.

    2. Postoperative Pain Scores (NRS) [24.5 hours after surgery]

      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.

    3. Postoperative Pain Scores (NRS) [48 hours after surgery]

      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).

    4. Postoperative Pain Scores (SNUIPS) [24 hours after surgery]

      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.

    5. Postoperative Pain Scores (SNUIPS) [24.5 hours after surgery]

      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.

    6. Postoperative Pain Scores (SNUIPS) [48 hours after surgery]

      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'.

    7. Postoperative Consumption of Patient-Controlled and/or Rescue Analgesics [24 hours after surgery]

      Amount of analgesics consumed through intravenous patient-controlled analgesia and/or administration of rescue analgesics

    8. Postoperative Consumption of Patient-Controlled and/or Rescue Analgesics [24.5 hours after surgery]

      Amount of analgesics consumed through intravenous patient-controlled analgesia and/or administration of rescue analgesics

    9. Postoperative Consumption of Patient-Controlled and/or Rescue Analgesics [48 hours after surgery]

      Amount of analgesics consumed through intravenous patient-controlled analgesia and/or administration of rescue analgesics

    10. Understandability of Pain Scales [48 hours after surgery]

      Survey among patients on understandability pain scales

    11. Convenience of Pain Scales [48 hours after surgery]

      Survey among patients on convenience of pain scales

    12. Patient Satisfaction of Postoperative Pain Management [48 hours after surgery]

      Survey among patients on their level of overall satisfaction on postoperative pain management

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 79 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Adult patients undergoing a gynecological or orthopedic surgery under general anesthesia

    • Administered with intravenous patient-controlled analgesia for postoperative pain control

    • American Society of Anesthesiologists physical status class I-III patients

    Exclusion Criteria:
    • Contraindicated against fentanyl

    • Unable to communicate

    • Aged less than 18, or more than 79

    • Weighs less than 40kg or more than 89kg

    • Has severe heart disease(s)

    • Pregnant

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Seoul Korea, Republic of 03080

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    • Principal Investigator: Jin-Tae Kim, Seoul National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Jin-Tae Kim, Professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT03764046
    Other Study ID Numbers:
    • SNUMR2-2
    First Posted:
    Dec 4, 2018
    Last Update Posted:
    Dec 4, 2018
    Last Verified:
    Dec 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jin-Tae Kim, Professor, Seoul National University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 4, 2018