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

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.

Study Overview

• Status: Completed
• Conditions: Cesarean Section Complications
• Intervention / Treatment: Other: Elective cesarean section

• Study Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet, Copenhagen University Hospital
  • Hillerød, Denmark, 3400
    • North Zealand Hospital, Hillerød

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All adult women undergoing an elective cesarean section in one of the three participating hospitals are eligible for inclusion.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• cesarean section performed under general anesthesia

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	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.	4 to 7 days after the elective cesarean section

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery	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	4 to 7 days after the elective cesarean section
Physical function	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	4 to 7 days after the elective cesarean section

Collaborators and Investigators

• Sponsor: Sygehus Lillebaelt
• Collaborators: 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

Publications and helpful links

Helpful Links

• CEPRA, Collaboration for Evidence-based Practice and Research in Anesthesia

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2023
• Primary Completion (Actual): November 10, 2023
• Study Completion (Actual): November 20, 2023

Study Registration Dates

• First Submitted: June 21, 2023
• First Submitted That Met QC Criteria: July 3, 2023
• First Posted (Actual): July 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: postoperative pain; postoperative function; patient-relevant outcomes
• Other Study ID Numbers: 979809337

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No