Psychological factors affecting postoperative pain and visceral discomfort in patients with cesarean section: a prospective observational study

Conditions: MG30.21CHRONIC POSTSURGICAL PAI

Registration Number: DRKS00028188

Lead Sponsor: niversitätsklinikum EssenKlinik für Anästhesiologie und Intensivmedizin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Female

Target Recruitment: 128

Inclusion Criteria

Adult female patients with an appointment for scheduled spinal anesthesia (SPA) caesarean section.
- Ability to fully understand the nature and purpose of the study
- Ability to cooperate with the study team and comply with the requirements of the entire study
- Signed written informed consent for the observational study and separate consent for saliva sample analysis
- Consent prior to surgery

Exclusion Criteria

- Secondary caesarean section
- Sectio caesarea with high health risk for mother (e.g., preeclampsia, amniotic infection syndrome, umbilical cord prolapse, uterine rupture) or child (very preterm or preterm premature birth, <32+0 SSW),
- Age of mother >40 years
- Insufficient knowledge of German
- Refusal to participate
- Peri- and postoperative complication of the mother (e.g. amniotic fluid embolism) or the child, which subsequently lead to exclusion

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure is the incidence of persistent postoperative pain, defined as abdominal pain intensity on a Numeric Rating Scale (NRS = 3) three months after caesarean section.

Secondary Outcome Measures

Name	Time	Method
Secondary outcome measures are dysfunction of the gut-brain axis, psychological well-being, quality of life, impairment in daily life, analgesic consumption.<br><br>Preoperative treatment expectations and specific treatment-related anxiety as well as moderating factors (symptoms of anxiety, depression, stress, cortisol level in saliva; medical factors, especially duration of surgery, anesthesia procedure, etc.; perceived quality of doctor-patient communication/satisfaction) are recorded as predictor variables.