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

Surgery Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03764046
• Other study ID #: SNUMR2-2
• Status: Not yet recruiting
• Start date: January 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: December 2018
• Source: Seoul National University Hospital
• Contact: Jin-Tae Kim, MD, PhD
• Phone: +82-2-2072-3664
• Email: jintae73[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (11)

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. — View 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. — View 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. Review. — View Citation

Eriksson K, Wikström L, Årestedt K, Fridlund B, Broström 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. — View Citation

Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. — View Citation

Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct;27(1):117-26. — View 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. Review. — View Citation

Katz J, Melzack R. Measurement of pain. Surg Clin North Am. 1999 Apr;79(2):231-52. Review. — View 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. — View Citation

Pathak A, Sharma S, Jensen MP. The utility and validity of pain intensity rating scales for use in developing countries. Pain Reports [Internet] 2018;3(5):e672. Available from: http://dx.doi.org/10.1097/PR9.0000000000000672

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Understandability of Pain Scales	Survey among patients on understandability pain scales	48 hours after surgery
Primary	Convenience of Pain Scales	Survey among patients on convenience of pain scales	48 hours after surgery
Primary	Patient Satisfaction of Postoperative Pain Management	Survey among patients on their level of overall satisfaction on postoperative pain management	48 hours after surgery