AzTrials
AzTrials

Pain MeasurementNCT03764046

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

An observational study of Pain Measurement and Acute Pain, run by Seoul National University Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
Pain Measurement, Acute Pain, Postoperative Pain
How many people
100 participants
Where
1 siteSouth Korea
Study dates
1 Jan 2019to 31 Dec 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 100 adult patients undergoing postoperative pain control after a gynecological or orthopedic surgery at Seoul National University Hospital

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Jin-Tae Kim, MD, PhD contact

+82-2-2072-3664

jintae73@gmail.com

South Korea1 site

  • Seoul National University Hospital

    Seoul, 03080

Other trials in South Korea

About this study

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

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.

Keywords
Pain Measurement, Acute Postoperative Pain
Medical subject headings
Acute Pain, Pain, Postoperative

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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).

    Measured: 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.

    Measured: 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.

    Measured: 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'.

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 48 hours after surgery

  10. Understandability of Pain Scales

    Survey among patients on understandability pain scales

    Measured: 48 hours after surgery

  11. Convenience of Pain Scales

    Survey among patients on convenience of pain scales

    Measured: 48 hours after surgery

  12. Patient Satisfaction of Postoperative Pain Management

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

    Measured: 48 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2018
  2. Study start1 Jan 2019 (estimated)
  3. Primary completion31 Oct 2019 (estimated)
  4. Study completion31 Dec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03764046
Sponsor's protocol ID
SNUMR2-2
Status last verified
Dec 2018
First submitted
30 Nov 2018
Last updated
4 Dec 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Pain Measurement and Acute Pain, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jin-Tae Kim, MD, PhD (+82-2-2072-3664, jintae73@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Pain Scores (NRS) (time frame: 24 hours after surgery). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03764046, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2018.

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