NCT03764046|Unknown
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Sponsor study identifier
observational
100
1 country
1
Study Start
January 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 30, 2018
Actual (reported)December 4, 2018
Actual (reported)January 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
100 adult patients undergoing postoperative pain control after a gynecological or orthopedic surgery at Seoul National University Hospital
Seoul National University Hospital
Seoul, 03080, South Korea
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.
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.
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.
Jin-Tae Kim
Seoul National University Hospital
First Submitted
November 30, 2018
First Posted
December 4, 2018
Study Start
January 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 31, 2019
Prediction Model of Acute Postoperative Pain in Bilateral Total Knee Replacement Arthroplasty Patient
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
Contact the study team to confirm eligibility.
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.
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.
Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.
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.
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.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 4, 2018
Record last verified: 2018-12
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