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

NCT05933993 | Completed

• 1 other identifier: 979809337
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 2

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.

Conditions

Cesarean Section Complications

Keywords

postoperative pain; postoperative function; patient-relevant outcomes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Recovery

  4 to 7 days after the elective cesarean section

• Physical function

  4 to 7 days after the elective cesarean section

Study Arms (1)

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

Interventions

Elective cesarean section OTHER

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

Mothers, following an elective cesarean sections

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Every person undergoing an elective cesarean section is eligible for inclusion.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• cesarean section performed under general anesthesia

Sponsors & Collaborators

• Sygehus Lillebaelt: lead
• Department of Regional Health Research, University of Southern Denmark, Odense, Denmark: collaborator
• Department of Anesthesiology (4013), Copenhagen University Hospital, Copenhagen, Denmark: collaborator
• Nordsjaellands Hospital: collaborator

Study Sites (2)

Rigshospitalet, Copenhagen University Hospital

Copenhagen, 2100, Denmark

Location

North Zealand Hospital, Hillerød

Hillerød, 3400, Denmark

Location

Related Links

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

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Helene K Nedergaard

  Lillebaelt Hospital Kolding, Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary investigator

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: July 6, 2023
• Study Start: September 20, 2023
• Primary Completion: November 10, 2023
• Study Completion: November 20, 2023
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)