Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-02-28 @ 10:29 PM
Study NCT ID:
NCT02316951
Status:
TERMINATED
Last Update Posted:
2023-05-26
First Post:
2014-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monitoring Postoperative Pain and Recovery Following Orthopedic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Logistical and enrollment issues', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-08-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-24', 'studyFirstSubmitDate': '2014-12-10', 'studyFirstSubmitQcDate': '2014-12-12', 'lastUpdatePostDateStruct': {'date': '2023-05-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-08-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain assessment (Correlate pain scores with motion measurements obtained through measurement of movement activity and video.)', 'timeFrame': '1 day', 'description': 'Correlate pain scores with motion measurements obtained through measurement of movement activity and video.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postoperative', 'Pain', 'Symptoms', 'Video recording', 'Orthopedic surgery'], 'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'This pilot study will seek to use emotion recognition technology from video to link patient facial expressions, heart rate and respiratory rate changes, and movement patterns to patient pain scores.', 'detailedDescription': "During hospitalization, beginning after orthopedic surgery, study participants will be asked to wear a small motion detector on their wrist. A computer vision system which analyzes both whole-body movement as well as facial expressions will be used at the bedside to compare common signs and symptoms of post op pain to patient pain scores.\n\nUp to 30 study participants will be selected.\n\nStudy participants will be asked to complete a written pain diary during waking hours.This information will be compared to the pain scores found in the patient's medical record and/or the amount and frequency of pain medications they receive."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients (age \\>21) recovering from orthopedic surgery residing in an area hospital and under the care of the acute pain service.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recovery following Orthopedic Surgery\n* Non-vulnerable adult patient\n* Residing on the 6th floor of the South Tower of UF Health Shands Hospital\n* Under the care of the acute pain service\n\nExclusion Criteria:\n\n* Inability to understand pain assessments\n* Inability to wear a motion tracking device\n* Amputation of limb\n* Vulnerable subject status\n* Anticipated discharge from hospital within 24 hours following enrollment\n* \\< 21 years of age'}, 'identificationModule': {'nctId': 'NCT02316951', 'briefTitle': 'Monitoring Postoperative Pain and Recovery Following Orthopedic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Monitoring Postoperative Pain and Recovery Following Orthopedic Surgery', 'orgStudyIdInfo': {'id': 'IRB201400424'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'single-arm study group', 'description': "Study participants will be adult patients recovering from orthopedic surgery. The study group will wear a small motion detection device and a regular Webcam will be placed near the wall facing the bed in each patient's hospital room.", 'interventionNames': ['Device: single-arm study group']}], 'interventions': [{'name': 'single-arm study group', 'type': 'DEVICE', 'description': "Study participants will wear a small motion detection device and a regular Webcam will be placed near the wall facing the bed in each patient's hospital room. Study participants will be questioned about their sociodemographic, pain, and health history.", 'armGroupLabels': ['single-arm study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'UF Health', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Patrick Tighe, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}