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

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05933993
• Other study ID #: 979809337
• Status: Completed
• Start date: September 20, 2023
• Est. completion date: November 20, 2023

Study information

• Verified date: April 2024
• Source: Sygehus Lillebaelt
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 20, 2023
• Est. primary completion date: November 10, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• women undergoing an elective cesarean section under spinal anesthesia

• speaking/writing Danish

Exclusion Criteria:

• cesarean section performed under general anesthesia

Related Conditions & MeSH terms

• Cesarean Section Complications

Intervention

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

Locations

Country	Name	City	State
Denmark	Rigshospitalet, Copenhagen University Hospital	Copenhagen
Denmark	North Zealand Hospital, Hillerød	Hillerød

Sponsors (4)

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

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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

External Links

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