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

NCT05933993 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 27

Last updated 2024-04-26

No results posted yet for this study

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.

Conditions

  • Cesarean Section Complications

Interventions

OTHER

Elective cesarean section

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

Sponsors & Collaborators

  • Department of Regional Health Research, University of Southern Denmark, Odense, Denmark

    collaborator UNKNOWN
  • Department of Anesthesiology (4013), Copenhagen University Hospital, Copenhagen, Denmark

    collaborator UNKNOWN
  • Nordsjaellands Hospital

    collaborator OTHER
  • Sygehus Lillebaelt

    lead OTHER

Principal Investigators

  • Helene K Nedergaard · Lillebaelt Hospital Kolding, Department of Anesthesiology

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-20
Primary Completion
2023-11-10
Completion
2023-11-20

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05933993 on ClinicalTrials.gov