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

Sponsor
Sygehus Lillebaelt (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05933993
Collaborator
Department of Regional Health Research, University of Southern Denmark, Odense, Denmark (Other), Department of Anesthesiology (4013), Copenhagen University Hospital, Copenhagen, Denmark (Other), Department of Anesthesiology and Intensive Care, North Zealand Hospital, Hillerød, Denmark (Other)
30
2
12
15
1.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Elective cesarean section

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Mothers Experience of Pain Following Elective Cesarean Section. A Qualitative Study.
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
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.

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

Outcome Measures

Primary Outcome Measures

  1. Pain [4 to 7 days after the elective cesarean section]

    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.

Secondary Outcome Measures

  1. Recovery [4 to 7 days after the elective cesarean section]

    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

  2. Physical function [4 to 7 days after the elective cesarean section]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rigshospitalet, Copenhagen University Hospital Copenhagen Denmark 2100
2 North Zealand Hospital, Hillerød Hillerød Denmark 3400

Sponsors and Collaborators

  • Sygehus Lillebaelt
  • Department of Regional Health Research, University of Southern Denmark, Odense, Denmark
  • Department of Anesthesiology (4013), Copenhagen University Hospital, Copenhagen, Denmark
  • Department of Anesthesiology and Intensive Care, North Zealand Hospital, Hillerød, Denmark

Investigators

  • Principal Investigator: Helene K Nedergaard, Lillebaelt Hospital Kolding, Department of Anesthesiology

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Helene Korvenius Nedergaard, Primary investigator, Sygehus Lillebaelt
ClinicalTrials.gov Identifier:
NCT05933993
Other Study ID Numbers:
  • 979809337
First Posted:
Jul 6, 2023
Last Update Posted:
Jul 6, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Helene Korvenius Nedergaard, Primary investigator, Sygehus Lillebaelt

Study Results

No Results Posted as of Jul 6, 2023