Clinical trial NCT03764046: Development and Validation of New "SNU Illustrated Pain Rating Scale" as a Tool for Postoperative Pain Assessment
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain Measurement
Acute Pain
Postoperative Pain
Anesthesia
Surgery
Keywords: Pain Measurement
Acute Postoperative Pain
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-12-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility 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

Primary outcomes:
measure: Postoperative Pain Scores (NRS)
timeFrame: 24 hours after surgery
measure: Postoperative Pain Scores (NRS)
timeFrame: 24.5 hours after surgery
measure: Postoperative Pain Scores (NRS)
timeFrame: 48 hours after surgery
measure: Postoperative Pain Scores (SNUIPS)
timeFrame: 24 hours after surgery
measure: Postoperative Pain Scores (SNUIPS)
timeFrame: 24.5 hours after surgery
measure: Postoperative Pain Scores (SNUIPS)
timeFrame: 48 hours after surgery
measure: Postoperative Consumption of Patient-Controlled and/or Rescue Analgesics
timeFrame: 24 hours after surgery
measure: Postoperative Consumption of Patient-Controlled and/or Rescue Analgesics
timeFrame: 24.5 hours after surgery
measure: Postoperative Consumption of Patient-Controlled and/or Rescue Analgesics
timeFrame: 48 hours after surgery
measure: Understandability of Pain Scales
timeFrame: 48 hours after surgery
measure: Convenience of Pain Scales
timeFrame: 48 hours after surgery
measure: Patient Satisfaction of Postoperative Pain Management
timeFrame: 48 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
citation: 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.
citation: 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.
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. doi: 10.1016/j.jpainsymman.2004.08.007.
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. doi: 10.1016/0022-3999(66)90064-x. No abstract available.
citation: Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.
citation: 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.
citation: 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.
citation: 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.