Mothers Experience of Pain Following Elective Cesarean Section. A

Status Completed

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Cesarean Section Complications

Clinical Trial Details

NCT number	NCT05933993
Study type	Observational
Source	Sygehus Lillebaelt
Contact
Status	Completed
Phase
Start date	September 20, 2023
Completion date	November 20, 2023

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms