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NCT Number: NCT07409012

Development of a Patient-Centered Assessment Tool for Pain During Cesarean Delivery

This study aims to develop a standardized tool to assess intraoperative pain during cesarean delivery under neuroaxial anesthesia. The tool will draw on existing scientific literature, expert clinical opinion and the experiences of patients who have recently undergone caesarean delivery. Experts from multiple disciplines will participate in a structured consensus process (Delphi process) to identify and refine key assessment items. Patient interviews will be conducted to ensure that the tool reflects patient priorities and experiences.

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Key information

Conditions

Elective Cesarean Delivery

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University Hospital Basel

Basel, Canton of Basel-City, Switzerland

Location status: Recruiting

Location contact

Lena Anna Gschwandtner, Doctoral candidate

CONTACT

[email protected]

+41 61 32 83351

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Signed informed consent
  • Age > 18 years
  • Proficient in German or Swiss German
  • Category 2-4 Cesarean delivery under neuraxial anesthesia within last 48-72 hours
  • Delivery of an healthy infant of at least 35+1 weeks of gestation

Exclusion criteria

  • Known fetal abnormalities or neonatal death
  • Admission of the neonate to the ICU
  • Severe postpartum hemorrhage of >1000ml blood loss
  • Preeclampsia
  • Current psychiatric disease, e.g. schizophrenia, personality disorders
  • Substance abuse
  • Chronic pain disease

Treatment and study plan

Primary outcomes

  1. The development of an assessment tool with a consensus-based item set for pain during caesarean delivery.

    Time frame: 48-72 hours postoperatively

    As this is a study focusing on methodological development, the primary outcome is the establishment of a consensus-based, patient-centered assessment tool. This tool is derived from a literature review and finalized through a Delphi process (expert consensus) and patient-centered via cognitive interviews. As the outcome of this study is the finalized set of items, the tool will not be clinically applied to measure the incidence of pain during cesarean delivery within this study. It serves as a foundation for future psychometric validation and clinical application.

Secondary outcomes

  1. Identifying themes in qualitative interviews with patients regarding their informational priorities prior to cesarean delivery.

    Time frame: 48-72 hours postoperatively

    The secondary measure will be assessed in the qualitative interviews with patients after cesarean delivery, during which the items for the assessment tool will be discussed as well. Patients will be asked to share their informational priorities and what they want to know before undergoing a cesarean delivery. To measure this outcome, inductive coding and thematic analysis will be used to identify themes that describe these priorities.

Study contacts

Contact information is provided by the study sponsor or research team.

Lena Gschwandtner

CONTACT

[email protected]

+41 61 328 33 51

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Pain During Cesarean Delivery: a Patient-Centered Assessment Tool Developed With Mixed Methods

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2026
Registry last updated
Jul 24, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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