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

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ClinicalTrials.gov Identifier: NCT03764046
Recruitment Status : Unknown
Verified December 2018 by Jin-Tae Kim, Seoul National University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : December 4, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Jin-Tae Kim, Seoul National University Hospital

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
Pain Measurement Acute Pain Postoperative Pain Anesthesia Surgery

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Study Type : Observational
Estimated 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
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : December 31, 2019



Primary Outcome Measures :
  1. Postoperative Pain Scores (NRS) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 48 hours after surgery ]
    Amount of analgesics consumed through intravenous patient-controlled analgesia and/or administration of rescue analgesics

  10. Understandability of Pain Scales [ Time Frame: 48 hours after surgery ]
    Survey among patients on understandability pain scales

  11. Convenience of Pain Scales [ Time Frame: 48 hours after surgery ]
    Survey among patients on convenience of pain scales

  12. Patient Satisfaction of Postoperative Pain Management [ Time Frame: 48 hours after surgery ]
    Survey among patients on their level of overall satisfaction on postoperative pain management



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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
100 adult patients undergoing postoperative pain control after a gynecological or orthopedic surgery at Seoul National University Hospital
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03764046


Contacts
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Contact: Jin-Tae Kim, MD, PhD +82-2-2072-3664 jintae73@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jin-Tae Kim Seoul National University Hospital
Publications:

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Responsible Party: Jin-Tae Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03764046    
Other Study ID Numbers: SNUMR2-2
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jin-Tae Kim, Seoul National University Hospital:
Pain Measurement
Acute Postoperative Pain
Additional relevant MeSH terms:
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Pain, Postoperative
Acute Pain
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations