Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-02-26 @ 8:12 PM
Study NCT ID:
NCT03975660
Status:
COMPLETED
Last Update Posted:
2025-06-08
First Post:
2019-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Objective Pain Measurement Device
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D048949', 'term': 'Labor Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bcarvalho@stanford.edu', 'phone': '(650) 861-8607', 'title': 'Dr. Brendan Carvalho', 'organization': 'Stanford University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 day (average approximately 2 hours)', 'eventGroups': [{'id': 'EG000', 'title': 'Device Calibration and Validation', 'description': 'When participants request labor analgesia, the sensors of the pain measurement device are applied to the forehead and connected to the device. Data recording is then started.', 'otherNumAtRisk': 130, 'deathsNumAtRisk': 130, 'otherNumAffected': 0, 'seriousNumAtRisk': 130, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Average Self-report Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device Calibration and Validation', 'description': 'When participants request labor analgesia, the sensors of the pain measurement device are applied to the forehead and connected to the device. Data recording is then started.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.08', 'spread': '3.33', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During labor up to 2 hours after epidural', 'description': 'Average patient self-reported pain score on 0 to 10 scale (higher scores correspond to more pain)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Correlation of Average Device Pain Score to Average Self-report Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device Calibration and Validation', 'description': 'When participants request labor analgesia, the sensors of the pain measurement device are applied to the forehead and connected to the device. Data recording is then started.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.79', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During labor up to 2 hours after epidural', 'description': 'Pearson correlation', 'unitOfMeasure': 'correlation coefficient', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Correlation Between Pain Score and Brain Oxygenation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device Calibration and Validation', 'description': 'When participants request labor analgesia, the sensors of the pain measurement device are applied to the forehead and connected to the device. Data recording is then started.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During labor up to 2 hours after epidural', 'description': 'Pearson correlation between patient self-reported pain score on 0 to 10 scale (higher scores correspond to more pain) and brain oxygenation (0-100%). This outcome will be assessed in part 2 only.', 'unitOfMeasure': 'correlation coefficient', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Correlation Between Pain Score and Noninvasive Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device Calibration and Validation', 'description': 'When participants request labor analgesia, the sensors of the pain measurement device are applied to the forehead and connected to the device. Data recording is then started.'}], 'classes': [{'title': 'Pain score and diastolic blood pressure', 'categories': [{'measurements': [{'value': '0.20', 'groupId': 'OG000'}]}]}, {'title': 'Pain score and systolic blood pressure', 'categories': [{'measurements': [{'value': '0.22', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During labor up to 2 hours after epidural', 'description': 'Pearson correlation between patient self-reported pain score on 0 to 10 scale (higher scores correspond to more pain) and hemodynamic parameter noninvasive blood pressure. This outcome will be assessed in part 2 only.', 'unitOfMeasure': 'correlation coefficient', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Correlation Between Pain Score and Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device Calibration and Validation', 'description': 'When participants request labor analgesia, the sensors of the pain measurement device are applied to the forehead and connected to the device. Data recording is then started.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.20', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During labor up to 2 hours after epidural', 'description': 'Pearson correlation between patient self-reported pain score on 0 to 10 scale (higher scores correspond to more pain) and hemodynamic parameter heart rate. This outcome will be assessed in part 2 only.', 'unitOfMeasure': 'correlation coefficient', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Correlation Between Pain Score and Pulse Oximetry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device Calibration and Validation', 'description': 'When participants request labor analgesia, the sensors of the pain measurement device are applied to the forehead and connected to the device. Data recording is then started.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During labor up to 2 hours after epidural', 'description': 'Correlation between patient self-reported pain score on 0 to 10 scale (higher scores correspond to more pain) and hemodynamic parameter pulse oximetry (Sp02). This outcome will be assessed in part 2 only.', 'unitOfMeasure': 'correlation coefficient', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Reach Pain Score 2 or Less Out of 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device Calibration and Validation', 'description': 'When participants request labor analgesia, the sensors of the pain measurement device are applied to the forehead and connected to the device. Data recording is then started.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.2', 'spread': '12.60', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'within 45 minutes after the block placement', 'description': 'Pain score on 0 to 10 scale (higher scores correspond to more pain)', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time Taken for Pain Device Score to be Below Validated Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device Calibration and Validation', 'description': 'When participants request labor analgesia, the sensors of the pain measurement device are applied to the forehead and connected to the device. Data recording is then started.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.6', 'spread': '12.22', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'within 45 minutes after the block placement', 'description': 'Validated value is from the validated reading recorded by the sensor in the pilot study', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Reported Pain Scores After Block', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device Calibration and Validation', 'description': 'When participants request labor analgesia, the sensors of the pain measurement device are applied to the forehead and connected to the device. Data recording is then started.'}], 'classes': [{'title': 'Participants with data obtained for ≥ 15 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '2.50', 'groupId': 'OG000'}]}]}, {'title': 'Participants with data obtained for ≥ 30 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '2.20', 'groupId': 'OG000'}]}]}, {'title': 'Participants with data obtained for ≥ 45 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.40', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to approximately 45 minutes after the block placement', 'description': 'Pain score on 0 to 10 scale (higher scores correspond to more pain). Pain scores were obtained at random intervals and the scores were summed and averaged to create the reported score. Patients stopped rating pain once the level dropped to zero.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data for the respective time frame'}, {'type': 'SECONDARY', 'title': 'Device Recorded Pain Scores After Block', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device Calibration and Validation', 'description': 'When participants request labor analgesia, the sensors of the pain measurement device are applied to the forehead and connected to the device. Data recording is then started.'}], 'classes': [{'title': 'Participants with data recording ≥ 15 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '1.90', 'groupId': 'OG000'}]}]}, {'title': 'Participants with data recording ≥ 30 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '1.99', 'groupId': 'OG000'}]}]}, {'title': 'Participants with data recording ≥ 45 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.44', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to approximately 45 minutes after the block placement', 'description': 'Device pain score validated measure (range: 0 to 10, higher scores correspond to more pain). Pain scores were obtained at random intervals and the scores were summed and averaged to create the reported score. Device recording was discontinued when pain level dropped to zero.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with data recorded within the respective time frame'}, {'type': 'SECONDARY', 'title': 'Dermatomal Level at 45 Minutes After Block Placement as a Measure of Sensory Blockade Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device Calibration and Validation', 'description': 'When participants request labor analgesia, the sensors of the pain measurement device are applied to the forehead and connected to the device. Data recording is then started.'}], 'timeFrame': '45 minutes', 'reportingStatus': 'POSTED', 'populationDescription': 'Dermatomal testing was not performed to reduce burden on participants. The study team decided it was not critical prior to the start of the study, however, the study protocol was not amended to reflect this change. No data were collected for this Outcome Measure.'}, {'type': 'SECONDARY', 'title': 'Count of Participants With Block Failures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device Calibration and Validation', 'description': 'When participants request labor analgesia, the sensors of the pain measurement device are applied to the forehead and connected to the device. Data recording is then started.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 45 minutes after the block placement', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Count of Participants With Maternal Side Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device Calibration and Validation', 'description': 'When participants request labor analgesia, the sensors of the pain measurement device are applied to the forehead and connected to the device. Data recording is then started.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 45 minutes after the block placement', 'description': 'Monitored maternal side effects will include nausea, pruritis, hypotension', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Count of Participants With Fetal Side Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device Calibration and Validation', 'description': 'When participants request labor analgesia, the sensors of the pain measurement device are applied to the forehead and connected to the device. Data recording is then started.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 45 minutes after the block placement', 'description': 'Monitored fetal side effects include fetal decelerations early/variable/late', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Count of Participants Needing Physician Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device Calibration and Validation', 'description': 'When participants request labor analgesia, the sensors of the pain measurement device are applied to the forehead and connected to the device. Data recording is then started.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 45 minutes after the block placement', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time From Epidural to Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device Calibration and Validation', 'description': 'When participants request labor analgesia, the sensors of the pain measurement device are applied to the forehead and connected to the device. Data recording is then started.'}], 'classes': [{'categories': [{'measurements': [{'value': '560', 'spread': '398', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'from epidural to delivery (average approximately 9 hours)', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Count of Participants With Normal Vaginal Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device Calibration and Validation', 'description': 'When participants request labor analgesia, the sensors of the pain measurement device are applied to the forehead and connected to the device. Data recording is then started.'}], 'classes': [{'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from epidural to delivery (expected average: 24 hours)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Count of Participants With Assisted Vaginal Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device Calibration and Validation', 'description': 'When participants request labor analgesia, the sensors of the pain measurement device are applied to the forehead and connected to the device. Data recording is then started.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from epidural to delivery (expected average: 24 hours)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Count of Participants With Cesarean Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Device Calibration and Validation', 'description': 'When participants request labor analgesia, the sensors of the pain measurement device are applied to the forehead and connected to the device. Data recording is then started.'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from epidural to delivery (expected average: 24 hours)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Device Calibration and Validation', 'description': 'When participants request labor analgesia, the sensors of the pain measurement device (ROPA System \\[CereVu Medical, Inc. San Francisco, CA\\] and Edwards Foresight device) are applied to the forehead and connected to the device. Data recording is then started.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '130'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '130'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Device Calibration and Validation', 'description': 'When participants request labor analgesia, the sensors of the pain measurement device are applied to the forehead and connected to the device. Data recording is then started.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '31.3', 'spread': '5.35', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '130', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '83', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}, {'title': 'Black', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Caucasian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}, {'title': 'Latin American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Native American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Unknown/Not Reported', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '130', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Skin Pigmentation Fitzpatrick Scale', 'classes': [{'title': 'Type I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}, {'title': 'Type II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}]}]}, {'title': 'Type III', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}, {'title': 'Type IV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}, {'title': 'Type V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Type VI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Type I: always burns, never tans (palest; freckles) Type II: usually burns, tans minimally (light colored but darker than pale) Type III: sometimes mild burn, tans uniformly (golden honey or olive) Type IV: burns minimally, always tans well (moderate brown) Type V: very rarely burns, tans very easily (dark brown) Type VI: never burns (deeply pigmented dark brown to darkest brown)', 'unitOfMeasure': 'Participants', 'populationDescription': 'Participants with skin pigmentation data'}, {'title': 'Skin Tone', 'classes': [{'title': 'Fair', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Light', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}, {'title': 'Light to Medium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}, {'title': 'Medium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': 'Medium to Dark', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}, {'title': 'Dark', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': 'Very Dark', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Deep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Participants with skin tone data'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-04', 'size': 1528681, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-10-24T17:09', 'hasProtocol': True}, {'date': '2024-10-24', 'size': 99992, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-10-31T16:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-06', 'studyFirstSubmitDate': '2019-06-01', 'resultsFirstSubmitDate': '2024-10-31', 'studyFirstSubmitQcDate': '2019-06-03', 'lastUpdatePostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-06', 'studyFirstPostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average Self-report Pain Score', 'timeFrame': 'During labor up to 2 hours after epidural', 'description': 'Average patient self-reported pain score on 0 to 10 scale (higher scores correspond to more pain)'}, {'measure': 'Correlation of Average Device Pain Score to Average Self-report Pain Score', 'timeFrame': 'During labor up to 2 hours after epidural', 'description': 'Pearson correlation'}, {'measure': 'Correlation Between Pain Score and Brain Oxygenation', 'timeFrame': 'During labor up to 2 hours after epidural', 'description': 'Pearson correlation between patient self-reported pain score on 0 to 10 scale (higher scores correspond to more pain) and brain oxygenation (0-100%). This outcome will be assessed in part 2 only.'}, {'measure': 'Correlation Between Pain Score and Noninvasive Blood Pressure', 'timeFrame': 'During labor up to 2 hours after epidural', 'description': 'Pearson correlation between patient self-reported pain score on 0 to 10 scale (higher scores correspond to more pain) and hemodynamic parameter noninvasive blood pressure. This outcome will be assessed in part 2 only.'}, {'measure': 'Correlation Between Pain Score and Heart Rate', 'timeFrame': 'During labor up to 2 hours after epidural', 'description': 'Pearson correlation between patient self-reported pain score on 0 to 10 scale (higher scores correspond to more pain) and hemodynamic parameter heart rate. This outcome will be assessed in part 2 only.'}, {'measure': 'Correlation Between Pain Score and Pulse Oximetry', 'timeFrame': 'During labor up to 2 hours after epidural', 'description': 'Correlation between patient self-reported pain score on 0 to 10 scale (higher scores correspond to more pain) and hemodynamic parameter pulse oximetry (Sp02). This outcome will be assessed in part 2 only.'}], 'secondaryOutcomes': [{'measure': 'Time to Reach Pain Score 2 or Less Out of 10', 'timeFrame': 'within 45 minutes after the block placement', 'description': 'Pain score on 0 to 10 scale (higher scores correspond to more pain)'}, {'measure': 'Time Taken for Pain Device Score to be Below Validated Value', 'timeFrame': 'within 45 minutes after the block placement', 'description': 'Validated value is from the validated reading recorded by the sensor in the pilot study'}, {'measure': 'Patient Reported Pain Scores After Block', 'timeFrame': 'Up to approximately 45 minutes after the block placement', 'description': 'Pain score on 0 to 10 scale (higher scores correspond to more pain). Pain scores were obtained at random intervals and the scores were summed and averaged to create the reported score. Patients stopped rating pain once the level dropped to zero.'}, {'measure': 'Device Recorded Pain Scores After Block', 'timeFrame': 'Up to approximately 45 minutes after the block placement', 'description': 'Device pain score validated measure (range: 0 to 10, higher scores correspond to more pain). Pain scores were obtained at random intervals and the scores were summed and averaged to create the reported score. Device recording was discontinued when pain level dropped to zero.'}, {'measure': 'Dermatomal Level at 45 Minutes After Block Placement as a Measure of Sensory Blockade Level', 'timeFrame': '45 minutes'}, {'measure': 'Count of Participants With Block Failures', 'timeFrame': 'within 45 minutes after the block placement'}, {'measure': 'Count of Participants With Maternal Side Effects', 'timeFrame': 'within 45 minutes after the block placement', 'description': 'Monitored maternal side effects will include nausea, pruritis, hypotension'}, {'measure': 'Count of Participants With Fetal Side Effects', 'timeFrame': 'within 45 minutes after the block placement', 'description': 'Monitored fetal side effects include fetal decelerations early/variable/late'}, {'measure': 'Count of Participants Needing Physician Intervention', 'timeFrame': 'within 45 minutes after the block placement'}, {'measure': 'Time From Epidural to Delivery', 'timeFrame': 'from epidural to delivery (average approximately 9 hours)'}, {'measure': 'Count of Participants With Normal Vaginal Delivery', 'timeFrame': 'from epidural to delivery (expected average: 24 hours)'}, {'measure': 'Count of Participants With Assisted Vaginal Delivery', 'timeFrame': 'from epidural to delivery (expected average: 24 hours)'}, {'measure': 'Count of Participants With Cesarean Delivery', 'timeFrame': 'from epidural to delivery (expected average: 24 hours)'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Pain', 'Analgesia', 'Labor Pain']}, 'descriptionModule': {'briefSummary': 'This study will attempt to objectively measure pain with an experimental device. The investigators will apply the device to measure patients "pain" due to uterine contractions during routine clinical care to correlate patients verbal pain ratings and analgesia requirements to that measured by the device. A brain oxygenation device, Edwards Foresight, will be used to concurrently to monitor brain oxygenation and hemodynamics, so the relationship between the CereVu ROPA device objective measure of pain and brain oxygenation/hemodynamic changes and patient-reported pain can be determined.', 'detailedDescription': 'Despite all the progress in our understanding of the basic mechanisms of pain, the gold standard for measuring pain is still a subjective verbal numeric rating scale rating (0-10) obtained from the individual reporting pain. This method is not objective and cannot be used in all patient populations. This study will attempt to objectively measure pain in laboring mothers with a pain measurement device. The investigators aim to 1) see if the pain measurement device (CereVu ROPA) is capable of reflecting different levels of pain ratings in patients in labor having uterine contractions and then changes in pain after receiving different neuraxial techniques for labor pain and to 2) additionally determine the relationship between the CereVu ROPA device, brain oxygenation/hemodynamic changes and patient-reported pain scores.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-50\n* ASA 1 or 3 +/-E\n* Patient requesting epidural labor analgesia\n* Good toco tracing (clearly showing contractions at least every 5 minutes)\n* Pain score greater than or equal to 3 out of 10 with contractions\n\nExclusion Criteria:\n\n* History of chronic pain\n* History of chronic opioid use\n* BMI \\> 45\n* Allergy to sensor adhesive material, local anesthetic or opioids\n* Contraindication to neuraxial block\n* Patient on magnesium infusion\n* Inability to give informed consent or understand English'}, 'identificationModule': {'nctId': 'NCT03975660', 'briefTitle': 'Evaluation of Objective Pain Measurement Device', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Evaluation of Objective Pain Measurement Device', 'orgStudyIdInfo': {'id': '51101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Device Calibration and Validation', 'description': 'Patients requesting epidural labor analgesia will have pain levels monitored during labor.', 'interventionNames': ['Device: Pain Measurement Device']}], 'interventions': [{'name': 'Pain Measurement Device', 'type': 'DEVICE', 'description': 'When participants request labor analgesia, the sensors of the pain measurement device (ROPA System \\[CereVu Medical, Inc. San Francisco, CA\\] and Edwards Foresight device) will be applied to the forehead and connected to the device. Data recording is then started.', 'armGroupLabels': ['Device Calibration and Validation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Brendan Carvalho, MBBCh, FRCA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Division of Obstetric Anesthesia Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine', 'investigatorFullName': 'Brendan Carvalho', 'investigatorAffiliation': 'Stanford University'}}}}