Clinical trial NCT05933993: Mothers Experience of Pain Following Elective Cesarean Section. A Qualitative Study.
Official title: Mothers Experience of Pain Following Elective Cesarean Section. A Qualitative Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean Section Complications
Keywords: postoperative pain
postoperative function
patient-relevant outcomes
Lead sponsor: Sygehus Lillebaelt
Sponsor class: OTHER
Collaborators: name: Department of Regional Health Research, University of Southern Denmark, Odense, Denmark
name: Department of Anesthesiology (4013), Copenhagen University Hospital, Copenhagen, Denmark
name: Department of Anesthesiology and Intensive Care, North Zealand Hospital, Hillerød, Denmark
First posted: 2023-07-06
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* cesarean section performed under general anesthesia

Primary outcomes:
measure: Pain
timeFrame: 4 to 7 days after the elective cesarean section
Secondary outcomes:
measure: Recovery
timeFrame: 4 to 7 days after the elective cesarean section
measure: Physical function
timeFrame: 4 to 7 days after the elective cesarean section
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Copenhagen University Hospital
city: Hillerød
country: Denmark
facility: North Zealand Hospital, Hillerød
Study officials:
affiliation: Lillebaelt Hospital Kolding, Department of Anesthesiology
name: Helene K Nedergaard
role: PRINCIPAL_INVESTIGATOR
References: