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Status unknownNCT03764046Updated Dec 4, 2018

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

An observational study in Pain Measurement, Acute Pain and Postoperative Pain, sponsored by Seoul National University Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2018-12-04.

Sponsored by Seoul National University Hospital · Observational

The sponsor has not verified this record recently (last verified Dec 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 79 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pain Measurement
  • Acute Pain
  • Postoperative Pain
  • Anesthesia
  • Surgery

Keywords

  • Pain Measurement
  • Acute Postoperative Pain
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 100 is close to the median of 102 across 608 observational studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 79 Years
Sexes eligible
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

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Postoperative Pain Scores (NRS)

    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.

    Time frame: 24 hours after surgery

  2. Postoperative Pain Scores (NRS)

    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.

    Time frame: 24.5 hours after surgery

  3. Postoperative Pain Scores (NRS)

    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).

    Time frame: 48 hours after surgery

  4. Postoperative Pain Scores (SNUIPS)

    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.

    Time frame: 24 hours after surgery

  5. Postoperative Pain Scores (SNUIPS)

    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.

    Time frame: 24.5 hours after surgery

  6. Postoperative Pain Scores (SNUIPS)

    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'.

    Time frame: 48 hours after surgery

  7. Postoperative Consumption of Patient-Controlled and/or Rescue Analgesics

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

    Time frame: 24 hours after surgery

  8. Postoperative Consumption of Patient-Controlled and/or Rescue Analgesics

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

    Time frame: 24.5 hours after surgery

  9. Postoperative Consumption of Patient-Controlled and/or Rescue Analgesics

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

    Time frame: 48 hours after surgery

  10. Understandability of Pain Scales

    Survey among patients on understandability pain scales

    Time frame: 48 hours after surgery

  11. Convenience of Pain Scales

    Survey among patients on convenience of pain scales

    Time frame: 48 hours after surgery

  12. Patient Satisfaction of Postoperative Pain Management

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

    Time frame: 48 hours after surgery

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, 03080, Korea, Republic of
08

References and documents

Publications

  • 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. PubMed 3785962 ↗
  • 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. PubMed 18487245 ↗
  • 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. PubMed 29321111 ↗
  • 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. PubMed 30534623 ↗
  • 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. PubMed 24332467 ↗
  • 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. PubMed 15652435 ↗
  • 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. PubMed 4165548 ↗
  • Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available. PubMed 4139420 ↗
  • 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. PubMed 11748392 ↗
  • 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. PubMed 10352653 ↗
  • 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. PubMed 14976305 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03764046
Lead sponsor
Seoul National University Hospital
Responsible party
Jin-Tae Kim (Professor, Seoul National University Hospital) — Principal investigator
First posted
Dec 4, 2018
Start date
Jan 1, 2019 (estimated)
Primary completion
Oct 31, 2019 (estimated)
Completion
Dec 31, 2019 (estimated)
Last update
Dec 4, 2018

Study contacts

Jin-Tae Kim, MD, PhD
Contact
jintae73@gmail.com
+82-2-2072-3664
Jin-Tae Kim
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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