Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-27 @ 11:07 PM
Study NCT ID:
NCT05933993
Status:
COMPLETED
Last Update Posted:
2024-04-26
First Post:
2023-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mothers Experience of Pain Following Elective Cesarean Section. A Qualitative Study.
Sponsor:
Sygehus Lillebaelt
Organization:
Study Overview
Official Title:
Mothers Experience of Pain Following Elective Cesarean Section. A Qualitative Study.
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: