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An exploratory study of the association between perinatal pain experience, physical activity and maternal functioning after caesarean section

An exploratory study of the association between perinatal pain experience, physical activity and maternal functioning after caesarean section - PACMATE

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00033070
Enrollment
85
Registered
2023-11-28
Start date
2023-12-01
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

primary and secondary caesarean section acute postoperative pain O82 R52.0

Interventions

Group 1: Patients after primary and secondary caesarean section wear an activity tracker Actigraph GT-3X for 7 days postoperatively, as well as they recieve questionnaires (PROM) on day 1, 4, 7 and 30

Sponsors

Universitätsklinikum Jena
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - written and informed consent - Ceasarean section performed

Exclusion criteria

Exclusion criteria: - Patient does not speak German or has communication difficulties - Participation in another clinical trial

Design outcomes

Primary

MeasureTime frame
Correlation between physical activity (between PPT4 - PPT6) and maternal functioning at PPT7 (Barkin Index of Maternal Functioning, BIMF; total score).

Secondary

MeasureTime frame
- correlative association of postoperative pain intensity (pain on exertion, maximum pain, pain at rest) and physical activity (number of steps/day (total daily steps, TDS)) at PPT1, PPT4 and PPT7 - correlative association of postoperative pain intensity (pain on exertion, maximum pain, pain at rest), maternal functioning (BIMF, total score) and physical activity (TDS) at PPT4 and PPT7 - Prognostic Analysis: o correlative association of early postoperative pain intensity (pain on exertion, maximum pain, pain at rest) at PPT1 and physical activity (TDS) at PPT7 o correlative association of early postoperative pain intensity (pain on exertion, maximum pain, pain at rest) on PPT1 and maternal functioning (BIMF, total score) on PPT7 o correlative association of cumulative activity (TDS, PTT1-7) and maternal functioning (BIMF, total score), quality of the postpartum relationship between mother and child (Postpartum Bonding Questionnaire, PBQ-16, total score), symptoms of postpartum depression (Edinburgh Postnatal Depression Screen, EPDS; total score) and maternal quality of life (EQ-5D-5L, Visual Analog Scale and subdomains) on PPT30 o Differences in cumulative activity (TDS, PTT1-7) between patients with complications occurring between PTT8 and PTT30 (e.g. readmissions) Differences between the groups of primary vs. secundary section: o Aktivity profile (TDS) between PPT1 – PPT7 o perinatal pain experience (especially postoperative pain intensity) on PPT1, PPT4, PPT7 and PPT30 o maternal functioning (BIMF, total score) on PPT4, PPT7 and PPT30 o Quality of postparum relationship between mother and child (PBQ-16, total score), symptoms of postpartum depressions (EPDS, total score) and maternal quality of life (EQ-5D-5L, visual analog scale and subdomains) on PPT30 Exploratively, the above-mentioned analyses are to be carried out with further variables of objective activity measurement (e.g. mean number of steps per minute, sleep duration, calorie consumpt

Countries

Germany

Contacts

Public ContactWinfried Meißner

Universtitätsklinikum JenaUniverstiätsklinikum Jena, Klinik für Anästhesiologie und Intensivmedizin, Sektion Schmerzmedizin

winfried.meissner@med.uni-jena.de+49 3641 9-323353

Outcome results

None listed

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