Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-31 @ 5:05 PM
Study NCT ID:
NCT01012466
Status:
COMPLETED
Last Update Posted:
2019-07-29
First Post:
2009-11-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Physical Effects of Pain Catastrophizing in Labor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048949', 'term': 'Labor 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-24', 'studyFirstSubmitDate': '2009-11-12', 'studyFirstSubmitQcDate': '2009-11-12', 'lastUpdatePostDateStruct': {'date': '2019-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relationship between pain catastrophizing and abnormal labor (deviation of progress in labor from norms)', 'timeFrame': 'Immediate postpartum'}], 'secondaryOutcomes': [{'measure': 'Relationship between pain catastrophizing and reported pain in labor', 'timeFrame': '1 day postpartum and 4-8 weeks postpartum'}, {'measure': 'Relationship between pain catastrophizing and satisfaction with birth experience and care', 'timeFrame': '1 day postpartum and 4-8 weeks postpartum'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pregnancy', 'birth', 'labor', 'labor pain', 'catastrophizing'], 'conditions': ['Pregnancy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether labor self-efficacy (as determined by scores for the Lederman PSEQ II (self-efficacy scores) impacts the second stage 2 length (nromal vs. prolonged) as determined by quartile ranges for our sample. Other studies have shown that women who experience intense pain in the earliest stages of labor have a higher risk of complications. The investigators want to know if negative thoughts can predict this outcome.', 'detailedDescription': 'Subjects will complete questionnaires at three timepoints: during the prenatal period, within 24-48 hours of giving birth, and 4-8 weeks postpartum. The questionnaires will measure pain catastrophizing, depression, maternal support, support and control in birth, and childbirth satisfaction. Chart review following delivery will record data such as length of labor, medication used, need for augmentation or surgical delivery, complications.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Nulliparous women attending the prenatal clinic at Oregon Health \\& Science University', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 20 weeks of pregnancy\n* Nulliparous\n* Singleton pregnancy\n* Low risk pregnancy\n\nExclusion Criteria:\n\n* Primiparous and multiparous women\n* Women who request cesarean delivery\n* Women who are pregnant with twins\n* Women who plan induction\n* Women who deliver before 37 weeks\n* Women enrolled in the "Centering Pregnancy" program at the Family Birth Center\n* High risk pregnancies\n* Severe mental illness that impairs cognition or function\n* Suicidal ideation\n* Women who do not speak English or Spanish'}, 'identificationModule': {'nctId': 'NCT01012466', 'briefTitle': 'The Physical Effects of Pain Catastrophizing in Labor', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'The Physical Effects of Pain Catastrophizing on Normal Labor', 'orgStudyIdInfo': {'id': '5203'}, 'secondaryIdInfos': [{'id': '5K12HD04348807'}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Beth Darnall, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Beth Darnall, PhD', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}