Artificial Intelligence to Evaluate Postoperative Pain Based on Facial Expression

Sponsor
Seoul National University Bundang Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05477303
Collaborator
(none)
120
1
46.7
2.6

Study Details

Study Description

Brief Summary

Patients' subjective complaints about pain intensity are difficult to objectively evaluate, and may lead to inadequate pain management, especially in patients with communication difficulties.

Condition or Disease Intervention/Treatment Phase
  • Other: taking a picture of a painful facial expression

Detailed Description

Analgesia nociception index (ANI 0-100) and patient-reported numeric rating scale (NRS 0-10) were trained on a convolutional neural network (CNN) model by linking the patients' facial expression with the score. By applying the predicted pain score by the AI model to evaluate pain, it is intended to measure the intensity of pain in an automatic, fast, and objective way for appropriate pain management.

Study Design

Study Type:
Observational
Anticipated Enrollment :
120 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Artificial Intelligence to Evaluate Postoperative Pain Based on Facial Expression Recognition and Analgesia Nociception Index
Actual Study Start Date :
Jun 17, 2022
Anticipated Primary Completion Date :
Apr 20, 2023
Anticipated Study Completion Date :
May 9, 2026

Outcome Measures

Primary Outcome Measures

  1. Facial expression [immediately preoperative, postoperative time]

    Painful facial expression

  2. analgesia nociception index [immediately preoperative, postoperative time]

    ANI score

  3. numeric rating scale [immediately preoperative, postoperative time]

    pain score

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 75 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Patients aged 19-75 years who were scheduled for elective laparoscopic abdominal surgery under general anesthesia

  • American Society of Anesthesiology (ASA) class I-II

Exclusion Criteria:
  • Patients who have difficulty in communicating and reporting pain

  • Underlying diseases: liver, kidney, brain

  • Patients with BMI greater than 30 and less than 18.5

  • Alcohol or drug dependent patients

  • Patients with severe or acute respiratory failure

  • Opioid, NSAID allergy

  • Patients who are scheduled to be admitted to the intensive care unit after surgery

  • Patients who undergo cooperative surgery

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Bundang Hospital Seongnam-si Gyunggi-do Korea, Republic of 13620

Sponsors and Collaborators

  • Seoul National University Bundang Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Park InSun, Clinical instructor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT05477303
Other Study ID Numbers:
  • B-2205-757-304
First Posted:
Jul 28, 2022
Last Update Posted:
Jul 28, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 28, 2022