CESARCOM Study Protocol: Assessing the Impact of Therapeutic Communication on Patients' Anxiety During Elective Cesarean Sections, - a Before-and-after Interventional Study

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Background: Anxiety is highly prevalent before elective caesarean sections and can have a negative impact on anesthetic outcomes, postoperative pain and maternal mental health. The use of pharmacological premedication is controversial, and non-pharmacological alternatives are increasingly being explored. Therapeutic communication, based on empathy, positive language and the conscious avoidance of negative or anxiety-inducing suggestions, has shown promise in other surgical settings. However, its effectiveness in obstetrics remains to be explored. Methods This is a single-centre, prospective, observational, before-and-after study. The study aims to assess whether implementing an on-line (asynchronous) training programme on therapeutic communication for obstetric care teams can reduce maternal anxiety following elective caesarean sections. The study includes two groups of 130 patients each, one before the intervention and one after. Anxiety levels will be assessed using the French version of the State-Trait Anxiety Inventory score, and the primary outcome will be the difference in scores after caesarean section between the two groups. Secondary outcomes include the proportion of patients with high anxiety levels (STAI-State score \>45), as well as staff satisfaction, feeling of relevance, and indicators of the feasibility of implementing the training. The intervention consists of a short (less than 1 hour) training course using podcasts and flashcards, combined with distributing a lexicon that promotes hypnosis-based therapeutic communication (HBTC). Staff participation, perceived relevance and satisfaction will be assessed using structured questionnaires based on the Likert scale. Linear and logistic regression analyses will be used to adjust for confounding variables, including baseline anxiety, psychiatric history, and intraoperative complications. Discussion This is the first study to evaluate the impact of a dedicated HBTC training programme on patient anxiety and staff experience in an obstetric surgical setting. By integrating this approach into routine cesarean section care, our aim is to improve the patient experience and enhance communication practices within clinical teams. The results could inform clinical practices on non-pharmacological strategies in obstetric care.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• ≥18 years

⁃ elective c-section planned in the Maternity Unit of the Geneva University Hospitals

⁃ consent to participate

Locations
Other Locations
Switzerland
HUG
RECRUITING
Geneva
Contact Information
Primary
Océane Pécheux
oceane.pecheux@hug.ch
+41795535095
Backup
Mélissa Vocat
melissa.vocat@hug.ch
+41795532284
Time Frame
Start Date: 2025-04-14
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 260
Treatments
No_intervention: Pre intervention group (before hypnosis-based therapeutic communication reaching programme)
Patients' anxiety levels before the implementation of an online teaching programme about hypnosis based therapeutic communication in obstetrics.
Experimental: post intervention group (after hypnosis-based therapeutic communication teaching programme)
Patients' anxiety levels after the implementation of an online teaching programme about hypnosis based therapeutic communication in obstetrics.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Geneva

This content was sourced from clinicaltrials.gov