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Mothers Experience of Pain Following Elective Cesarean Section. A Qualitative Study.

Mothers Experience of Pain Following Elective Cesarean Section. A Qualitative Study.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05933993
Enrollment
27
Registered
2023-07-06
Start date
2023-09-20
Completion date
2023-11-20
Last updated
2024-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section Complications

Keywords

postoperative pain, postoperative function, patient-relevant outcomes

Brief summary

Background and aim: 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.

Interventions

OTHERElective cesarean section

The study does not contain an intervention in itself, but women are included if they undergo an elective cesarean section

Sponsors

Department of Regional Health Research, University of Southern Denmark, Odense, Denmark
CollaboratorUNKNOWN
Department of Anesthesiology (4013), Copenhagen University Hospital, Copenhagen, Denmark
CollaboratorUNKNOWN
Nordsjaellands Hospital
CollaboratorOTHER
Sygehus Lillebaelt
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* women undergoing an elective cesarean section under spinal anesthesia * speaking/writing Danish

Exclusion criteria

* cesarean section performed under general anesthesia

Design outcomes

Primary

MeasureTime frameDescription
Pain4 to 7 days after the elective cesarean sectionThe 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.

Secondary

MeasureTime frameDescription
Recovery4 to 7 days after the elective cesarean sectionA 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
Physical function4 to 7 days after the elective cesarean sectionA 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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026