Mothers Experience of Pain Following Elective Cesarean Section. A Qualitative Study.
NCT ID: NCT05933993
Last Updated: 2024-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
27 participants
OBSERVATIONAL
2023-09-20
2023-11-20
Brief Summary
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In 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.
The 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.
Methods:
This is a qualitative study based on semi-structured telephone interviews with women 4-7 days after an elective cesarean section.
The study will take place in three Danish hospitals (Kolding, Copenhagen and Hillerød).
Women aged 18 or above, scheduled for elective cesarean section, will be eligible for inclusion.
Women 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.
Interviews 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.
Baseline characteristics will be handled with descriptive statistics.
The primary outcome of the study is a thematic analysis of Danish womens experience of pain, recovery and function following an elective cesarean section.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Mothers, following an elective cesarean sections
The cohort in this study consists of Danish mothers, undergoing an elective cesarean section in one og the three participating hospitals.
Elective cesarean section
The study does not contain an intervention in itself, but women are included if they undergo an elective cesarean section
Interventions
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Elective cesarean section
The study does not contain an intervention in itself, but women are included if they undergo an elective cesarean section
Eligibility Criteria
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Inclusion Criteria
* speaking/writing Danish
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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Department of Regional Health Research, University of Southern Denmark, Odense, Denmark
UNKNOWN
Department of Anesthesiology (4013), Copenhagen University Hospital, Copenhagen, Denmark
UNKNOWN
Nordsjaellands Hospital
OTHER
Sygehus Lillebaelt
OTHER
Responsible Party
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Helene Korvenius Nedergaard
Primary investigator
Principal Investigators
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Helene K Nedergaard
Role: PRINCIPAL_INVESTIGATOR
Lillebaelt Hospital Kolding, Department of Anesthesiology
Locations
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Rigshospitalet, Copenhagen University Hospital
Copenhagen, , Denmark
North Zealand Hospital, Hillerød
Hillerød, , Denmark
Countries
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Related Links
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CEPRA, Collaboration for Evidence-based Practice and Research in Anesthesia
Other Identifiers
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979809337
Identifier Type: -
Identifier Source: org_study_id
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