Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2026-01-03 @ 9:09 PM
Study NCT ID:
NCT01996592
Status:
COMPLETED
Last Update Posted:
2018-08-13
First Post:
2013-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Persistent Pain After CS Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jbooth@wakehealth.edu', 'phone': '336-718-8278', 'title': 'Jessica L. Booth, MD', 'organization': 'Wake Forest School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Cesarean Section Deliveries', 'description': 'those subjects having an elective cesarean section will complete an informed consent form, complete the preoperative questionnaire, and then be contacted for 60 days postoperatively', 'otherNumAtRisk': 530, 'deathsNumAtRisk': 530, 'otherNumAffected': 0, 'seriousNumAtRisk': 530, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Persistent Pain-PERCEIVED STRESS Scores Stratified by the Rate of Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1-perceived Stress Scores', 'description': 'Subjects who had the fastest recovery'}, {'id': 'OG001', 'title': 'Group 2 Perceived Stress Scale', 'description': 'Subjects who experienced average recovery'}, {'id': 'OG002', 'title': 'Group 3 Perceived Stress Scale', 'description': 'Subjects who experienced the slowest recovery from surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '11.4', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '12.9', 'spread': '5.8', 'groupId': 'OG001'}, {'value': '15.4', 'spread': '5.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000'], 'pValueComment': 'p-value was calculated', 'groupDescription': 'PROMIS -perceived stress scale was utilized (a validated test). Scoring ranges from 0-40, with the following ranges indicative of low, moderate, or high perceived stress:\n\n0-13=low stress 14-26=moderate stress 27-40=high perceived stress', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '60 days', 'description': 'By identifying preoperative risk factors for chronic pain and mapping out the trajectory of pain after cesarean delivery, we may be able to use novel pharmacologic or psychological interventions to alter postoperative pain trajectories. Two predominant risk factors have been determined thus far to put those at risk. They are emotional distress/depression and perceived stress. The 530 participants recovery pain scores were broken down into 3 subgroups--group 1 is those who had the fastest recovery, group 2 which is the "average" recovery, and group 3 which is the group with the slowest recovery.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Persistent Pain-EMOTIONAL DISTRESS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '307', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1-emotional Distress Scores', 'description': 'Subjects who had the fastest recovery'}, {'id': 'OG001', 'title': 'Group 2 Emotional Distress Scale', 'description': 'Subjects who experienced average recovery'}, {'id': 'OG002', 'title': 'Group 3 Emotional Distress Scale', 'description': 'Subjects who experienced the slowest recovery from surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '10.7', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '11.5', 'spread': '4.2', 'groupId': 'OG001'}, {'value': '12.8', 'spread': '4.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'p-value was calculated', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '60 days', 'description': 'By identifying preoperative risk factors for chronic pain and mapping out the trajectory of pain after cesarean delivery, we may be able to use novel pharmacologic or psychological interventions to alter postoperative pain trajectories. Two predominant risk factors have been determined thus far to put those at risk. They are emotional distress/depression and perceived stress. The 530 participants recovery pain scores were broken down into 3 subgroups--group 1 is those who had the fastest recovery, group 2 which is the "average" recovery, and group 3 which is the group with the slowest recovery.\n\nPROMIS Emotional Distress-Depression Short form utilized for this outcome. scoring for this ranges from 8-40, with the higher the score the worse the distress', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cesarean Section Deliveries', 'description': 'those subjects having an elective cesarean section will complete an informed consent form, complete the preoperative questionnaire, and then be contacted for 60 days postoperatively'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '575'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '530'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}]}], 'dropWithdraws': [{'type': 'no response to text/no diary entry', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'change in surgical date', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'change in mode of delivery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Elective cesarean section patients \\>/= 18 years of age who agree to be contacted for 8 weeks after delivery to obtain pain scores'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '530', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Cesarean Section Deliveries', 'description': 'those subjects having an elective cesarean section will complete an informed consent form, complete the preoperative questionnaire, and then be contacted for 60 days postoperatively'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '530', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '530', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '575 enrolled; 530 analyzed. 45 subjects were excluded for the following reasons: no response to text/no diary entry: 32 change in surgical date: 4 withdrew consent prior to study initiation: 5 change in mode of delivery: 4'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '138', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '384', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': '575 enrolled; 530 analyzed. 45 subjects were excluded for the following reasons: no response to text/no diary entry: 32 change in surgical date: 4 withdrew consent prior to study initiation: 5 change in mode of delivery: 4'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 575}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-10', 'studyFirstSubmitDate': '2013-11-21', 'resultsFirstSubmitDate': '2017-06-15', 'studyFirstSubmitQcDate': '2013-11-21', 'lastUpdatePostDateStruct': {'date': '2018-08-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-10', 'studyFirstPostDateStruct': {'date': '2013-11-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Persistent Pain-PERCEIVED STRESS Scores Stratified by the Rate of Recovery', 'timeFrame': '60 days', 'description': 'By identifying preoperative risk factors for chronic pain and mapping out the trajectory of pain after cesarean delivery, we may be able to use novel pharmacologic or psychological interventions to alter postoperative pain trajectories. Two predominant risk factors have been determined thus far to put those at risk. They are emotional distress/depression and perceived stress. The 530 participants recovery pain scores were broken down into 3 subgroups--group 1 is those who had the fastest recovery, group 2 which is the "average" recovery, and group 3 which is the group with the slowest recovery.'}, {'measure': 'Persistent Pain-EMOTIONAL DISTRESS', 'timeFrame': '60 days', 'description': 'By identifying preoperative risk factors for chronic pain and mapping out the trajectory of pain after cesarean delivery, we may be able to use novel pharmacologic or psychological interventions to alter postoperative pain trajectories. Two predominant risk factors have been determined thus far to put those at risk. They are emotional distress/depression and perceived stress. The 530 participants recovery pain scores were broken down into 3 subgroups--group 1 is those who had the fastest recovery, group 2 which is the "average" recovery, and group 3 which is the group with the slowest recovery.\n\nPROMIS Emotional Distress-Depression Short form utilized for this outcome. scoring for this ranges from 8-40, with the higher the score the worse the distress'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic pain', 'cesarean section pain'], 'conditions': ['Persistent Pain After Delivery']}, 'descriptionModule': {'briefSummary': "Many factors influence the development of persistent pain after CS (chronic pain) as well as post-partum depression. We are attempting to use trajectory pain methods in an attempt to identify those at risk for the development of persistent pain post delivery using a daily method of contact for the determination of pain scores. Assessments are also done evaluating satisfaction of pain management and maternal/infant bonding opportunities. Physical activity is monitored by subject's wearing a Fitbit with correlation being done with pain scores obtained over 60 days postop with eligible subjects..", 'detailedDescription': "Subjects are contacted on a daily basis after having a cesarean delivery to determine current pain, current pain unpleasantness, worst pain, worst pain unpleasantness, average pain, and average pain unpleaseantness. Preoperatively subjects complete a psycho-social/depressive screening questionnaire. Pain treatments/satisfaction assessments are captured for the first 24 hours. Mother/baby outcomes are also captured. Physical activity and pain scores are also correlated with the subject's wearing of a Fitbit physical activity bracelet with eligible subjects for 60 days post-delivery."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'those subjects who are scheduled to have an elective cesarean section (CS) and able to complete a preoperative psychosocial/depressive questionnaire and who agree to be contacted on a daily basis for 60 days postoperatively', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>/= 18 years of age English speaking\n\nExclusion Criteria:\n\nnon-English speaking'}, 'identificationModule': {'nctId': 'NCT01996592', 'briefTitle': 'Persistent Pain After CS Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Novel Approach Using Pre-surgery Psychosocial State and Pain Trajectory Methods to Identify Patient Characteristics and Predict Patients at Risk for Persistent Pain After Cesarean Delivery', 'orgStudyIdInfo': {'id': 'IRB00022468'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'cesarean section deliveries', 'description': 'those subjects having an elective cesarean section will complete an informed consent form, complete the preoperative questionnaire, and then be contacted for 60 days postoperatively'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Forsyth Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Jessica Booth, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}