Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-30 @ 6:20 PM
Study NCT ID:
NCT05477303
Status:
RECRUITING
Last Update Posted:
2022-07-28
First Post:
2022-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Artificial Intelligence to Evaluate Postoperative Pain Based on Facial Expression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005149', 'term': 'Facial Expression'}, {'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D009633', 'term': 'Nonverbal Communication'}, {'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D010146', 'term': 'Pain'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2026-05-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-26', 'studyFirstSubmitDate': '2022-07-26', 'studyFirstSubmitQcDate': '2022-07-26', 'lastUpdatePostDateStruct': {'date': '2022-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Facial expression', 'timeFrame': 'immediately preoperative, postoperative time', 'description': 'Painful facial expression'}, {'measure': 'analgesia nociception index', 'timeFrame': 'immediately preoperative, postoperative time', 'description': 'ANI score'}, {'measure': 'numeric rating scale', 'timeFrame': 'immediately preoperative, postoperative time', 'description': 'pain score'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Artificial Intelligence', 'Facial Expression', 'Analgesia', 'Pain, Postoperative']}, 'referencesModule': {'references': [{'pmid': '38176698', 'type': 'DERIVED', 'citation': 'Park I, Park JH, Yoon J, Na HS, Oh AY, Ryu J, Koo BW. Machine learning model of facial expression outperforms models using analgesia nociception index and vital signs to predict postoperative pain intensity: a pilot study. Korean J Anesthesiol. 2024 Apr;77(2):195-204. doi: 10.4097/kja.23583. Epub 2024 Jan 5.'}, {'pmid': '38150126', 'type': 'DERIVED', 'citation': 'Park I, Park JH, Yoon J, Song IA, Na HS, Ryu JH, Oh AY. Artificial intelligence model predicting postoperative pain using facial expressions: a pilot study. J Clin Monit Comput. 2024 Apr;38(2):261-270. doi: 10.1007/s10877-023-01100-7. Epub 2023 Dec 27.'}]}, 'descriptionModule': {'briefSummary': "Patients' subjective complaints about pain intensity are difficult to objectively evaluate, and may lead to inadequate pain management, especially in patients with communication difficulties.", 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who were scheduled for elective laparoscopic abdominal surgery under general anesthesia', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 19-75 years who were scheduled for elective laparoscopic abdominal surgery under general anesthesia\n* American Society of Anesthesiology (ASA) class I-II\n\nExclusion Criteria:\n\n* Patients who have difficulty in communicating and reporting pain\n* Underlying diseases: liver, kidney, brain\n* Patients with BMI greater than 30 and less than 18.5\n* Alcohol or drug dependent patients\n* Patients with severe or acute respiratory failure\n* Opioid, NSAID allergy\n* Patients who are scheduled to be admitted to the intensive care unit after surgery\n* Patients who undergo cooperative surgery'}, 'identificationModule': {'nctId': 'NCT05477303', 'briefTitle': 'Artificial Intelligence to Evaluate Postoperative Pain Based on Facial Expression', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'Artificial Intelligence to Evaluate Postoperative Pain Based on Facial Expression Recognition and Analgesia Nociception Index', 'orgStudyIdInfo': {'id': 'B-2205-757-304'}}, 'armsInterventionsModule': {'interventions': [{'name': 'taking a picture of a painful facial expression', 'type': 'OTHER', 'description': "Immediately after surgery, the patient's facial expression and the NRS score and ANI score reported by the patient are checked together."}]}, 'contactsLocationsModule': {'locations': [{'zip': '13620', 'city': 'Seongnam-si', 'state': 'Gyunggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'InSun Park, MD', 'role': 'CONTACT', 'email': 'pis121@hanmail.net', 'phone': '82317877507'}], 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'centralContacts': [{'name': 'InSun Park, MD', 'role': 'CONTACT', 'email': 'pis121@hanmail.net', 'phone': '82317877499'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical instructor', 'investigatorFullName': 'Park InSun', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}