NCT07137377 Assessing the Impact of Therapeutic Communication on Patients' Anxiety During Elective Cesarean Sections
| NCT ID | NCT07137377 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Geneva |
| Condition | Communication |
| Study Type | INTERVENTIONAL |
| Enrollment | 260 participants |
| Start Date | 2025-04-14 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 260 participants in total. It began in 2025-04-14 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: -≥18 years * elective c-section planned in the Maternity Unit of the Geneva University Hospitals * consent to participate Exclusion Criteria: * Not-French-speaking patients (interpreter required). * All emergency c-sections. * Death during the intervention.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07137377 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Communication. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07137377 currently recruiting?
Yes, NCT07137377 is actively recruiting participants. Contact the research team at oceane.pecheux@hug.ch for enrollment information.
Where is the NCT07137377 trial being conducted?
This trial is being conducted at Geneva, Switzerland.
Who is sponsoring the NCT07137377 clinical trial?
NCT07137377 is sponsored by University Hospital, Geneva. The trial plans to enroll 260 participants.