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Completed

NCT Number: NCT05933993

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • cesarean section performed under general anesthesia

Treatment and study plan

Elective cesarean section

Other

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

Primary outcomes

  1. Pain

    Time frame: 4 to 7 days after the elective cesarean section

    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.

Secondary outcomes

  1. Recovery

    Time frame: 4 to 7 days after the elective cesarean section

    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

  2. Physical function

    Time frame: 4 to 7 days after the elective cesarean section

    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

Sponsors and collaborators

Lead sponsor

Sygehus Lillebaelt

Other

Collaborators

  • Department of Anesthesiology (4013), Copenhagen University Hospital, Copenhagen, Denmark
  • Nordsjaellands Hospital
  • University of Southern Denmark

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 6, 2023
Registry last updated
Apr 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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