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

Development and Validation of New "SNU Illustrated Pain Rating Scale" for Effective Assessment of Acute Postoperative Pain: a Comparative Study With Numeric Rating Scale

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain; Surgery; Acute Pain; Anesthesia; Pain Measurement

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours after surgery
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.	24.5 hours after surgery
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).	48 hours after surgery
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.	24 hours after surgery
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.	24.5 hours after surgery
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'.	48 hours after surgery
Postoperative Consumption of Patient-Controlled and/or Rescue Analgesics	Amount of analgesics consumed through intravenous patient-controlled analgesia and/or administration of rescue analgesics	24 hours after surgery
Postoperative Consumption of Patient-Controlled and/or Rescue Analgesics	Amount of analgesics consumed through intravenous patient-controlled analgesia and/or administration of rescue analgesics	24.5 hours after surgery
Postoperative Consumption of Patient-Controlled and/or Rescue Analgesics	Amount of analgesics consumed through intravenous patient-controlled analgesia and/or administration of rescue analgesics	48 hours after surgery
Understandability of Pain Scales	Survey among patients on understandability pain scales	48 hours after surgery
Convenience of Pain Scales	Survey among patients on convenience of pain scales	48 hours after surgery
Patient Satisfaction of Postoperative Pain Management	Survey among patients on their level of overall satisfaction on postoperative pain management	48 hours after surgery

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): October 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: November 30, 2018
• First Submitted That Met QC Criteria: December 3, 2018
• First Posted (Actual): December 4, 2018

Study Record Updates

• Last Update Posted (Actual): December 4, 2018
• Last Update Submitted That Met QC Criteria: December 3, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Pain Measurement; Acute Postoperative Pain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Acute Pain
• Other Study ID Numbers: SNUMR2-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No