Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-27 @ 11:07 PM
Study NCT ID:
NCT05933993
Status:
COMPLETED
Last Update Posted:
2024-04-26
First Post:
2023-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mothers Experience of Pain Following Elective Cesarean Section. A Qualitative Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-11-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-24', 'studyFirstSubmitDate': '2023-06-21', 'studyFirstSubmitQcDate': '2023-07-03', 'lastUpdatePostDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain', 'timeFrame': '4 to 7 days after the elective cesarean section', 'description': 'The primary outcome of the study is a thematic analysis of Danish womens experience of pain following an elective cesarean section. As the study is qualitative, no scale will be used to measure pain, but instead the experience of pain as described by the participants.'}], 'secondaryOutcomes': [{'measure': 'Recovery', 'timeFrame': '4 to 7 days after the elective cesarean section', 'description': 'A secondary outcome of the study is a thematic analysis of Danish womens experience of recovery following an elective cesarean section. As the study is qualitative, no scale will be used, but instead the experience of recovery following cesarean section, as described by the participants'}, {'measure': 'Physical function', 'timeFrame': '4 to 7 days after the elective cesarean section', 'description': 'A secondary outcome of the study is a thematic analysis of Danish womens experience of physical function following an elective cesarean section. As the study is qualitative, no scale will be used, but instead the experience of physical function following cesarean section, as described by the participants'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postoperative pain', 'postoperative function', 'patient-relevant outcomes'], 'conditions': ['Cesarean Section Complications']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.cepra.nu/', 'label': 'CEPRA, Collaboration for Evidence-based Practice and Research in Anesthesia'}]}, 'descriptionModule': {'briefSummary': 'Background and aim:\n\nIn Denmark, approx 56.000 babies are born every year, and approx 20% of them are born by cesarean sections. Half of these cesarean sections are elective. Previous studies have shown that many women experience severe pain in the days following the cesarean section, thus limiting their ability to care for their baby and recover.\n\nThe Danish national anesthesiological research network, CEPRA (Collaboration for Evidence based Practice and Research in Anesthesia) is planning a national study on pain following elective cesarean sections. In order to assure that the investigators will be using actual patient-relevant outcomes in this large national study, the aim with this qualitative study is to obtain knowledge on how Danish women experience pain, recovery and function following an elective cesarean section.\n\nMethods:\n\nThis is a qualitative study based on semi-structured telephone interviews with women 4-7 days after an elective cesarean section.\n\nThe study will take place in three Danish hospitals (Kolding, Copenhagen and Hillerød).\n\nWomen aged 18 or above, scheduled for elective cesarean section, will be eligible for inclusion.\n\nWomen will be informed about the study, orally and in writing, at the pre-anesthesiological consultation, which is held a few days before the cesarean section. Participation is completely voluntary. If they to participate, participants will sign a consent form. The investigators will include and interview participants until data saturation occurs. It is expected that 20-30 women should be included in total, evenly distributed at the three participating hospitals.\n\nInterviews will be held by telephone, recorded digitally and transscribed verbatim. Transscribed interviews will be coded for categories and themes using the NVivo software. Data will be analysed using manifest content analysis.\n\nBaseline characteristics will be handled with descriptive statistics.\n\nThe primary outcome of the study is a thematic analysis of Danish womens experience of pain, recovery and function following an elective cesarean section.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All adult women undergoing an elective cesarean section in one of the three participating hospitals are eligible for inclusion.', 'genderDescription': 'Every person undergoing an elective cesarean section is eligible for inclusion.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women undergoing an elective cesarean section under spinal anesthesia\n* speaking/writing Danish\n\nExclusion Criteria:\n\n* cesarean section performed under general anesthesia'}, 'identificationModule': {'nctId': 'NCT05933993', 'briefTitle': 'Mothers Experience of Pain Following Elective Cesarean Section. A Qualitative Study.', 'organization': {'class': 'OTHER', 'fullName': 'Sygehus Lillebaelt'}, 'officialTitle': 'Mothers Experience of Pain Following Elective Cesarean Section. A Qualitative Study.', 'orgStudyIdInfo': {'id': '979809337'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mothers, following an elective cesarean sections', 'description': 'The cohort in this study consists of Danish mothers, undergoing an elective cesarean section in one og the three participating hospitals.', 'interventionNames': ['Other: Elective cesarean section']}], 'interventions': [{'name': 'Elective cesarean section', 'type': 'OTHER', 'description': 'The study does not contain an intervention in itself, but women are included if they undergo an elective cesarean section', 'armGroupLabels': ['Mothers, following an elective cesarean sections']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet, Copenhagen University Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '3400', 'city': 'Hillerød', 'country': 'Denmark', 'facility': 'North Zealand Hospital, Hillerød', 'geoPoint': {'lat': 55.92791, 'lon': 12.30081}}], 'overallOfficials': [{'name': 'Helene K Nedergaard', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lillebaelt Hospital Kolding, Department of Anesthesiology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sygehus Lillebaelt', 'class': 'OTHER'}, 'collaborators': [{'name': 'Department of Regional Health Research, University of Southern Denmark, Odense, Denmark', 'class': 'UNKNOWN'}, {'name': 'Department of Anesthesiology (4013), Copenhagen University Hospital, Copenhagen, Denmark', 'class': 'UNKNOWN'}, {'name': 'Nordsjaellands Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Primary investigator', 'investigatorFullName': 'Helene Korvenius Nedergaard', 'investigatorAffiliation': 'Sygehus Lillebaelt'}}}}