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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00028188
Enrollment
120
Registered
2022-03-04
Start date
2022-03-13
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MG30.21CHRONIC POSTSURGICAL PAIN

Interventions

Group 1: The relationship between psychological influencing factors, in particular treatment expectations, and chronic postoperative abdominal pain will be investigated in 120 patients with planned se
everyday life impairments due to pain (PAIN-OUT questionnaire and Brief Pain Inventory) - Gastrointestinal complaints
urogenital complaints. - Physical and mental health/quality of life (VR12) and child's health status - state of health (DASS) - Therapy satisfaction - Medication/analgesic consumption,

Sponsors

Universitätsklinikum EssenKlinik für Anästhesiologie und Intensivmedizin
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

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

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, 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Secondary outcome measures are dysfunction of the gut-brain axis, psychological well-being, quality of life, impairment in daily life, analgesic consumption. 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.

Countries

Germany

Contacts

Public ContactJana Aulenkamp

Universitätsklinikum EssenKlinik für Anästhesiologie

jana.aulenkamp@uk-essen.de0201-723 86219

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026