Assessing the Impact of Therapeutic Communication on Patients' Anxiety During Elective Cesarean Sections (CESARCOM)

University Hospitals (UH)

Status: Enrolling

Conditions: Communication; Anxiety

Treatments: Behavioral: On line teaching CESARCOM teaching programe (immersive podcasts, digital flashcards)

Study type: Interventional

Funder types: Other

Identifiers

NCT07137377

ID 2024-02495

PRD 05-2024-II (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 260 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

---

260 participants in 2 patient groups

Pre intervention group (before hypnosis-based therapeutic communication reaching programme)

No Intervention group

Description:

Patients' anxiety levels before the implementation of an online teaching programme about hypnosis based therapeutic communication in obstetrics.

post intervention group (after hypnosis-based therapeutic communication teaching programme)

Experimental group

Description:

Patients' anxiety levels after the implementation of an online teaching programme about hypnosis based therapeutic communication in obstetrics.

Treatment:

Behavioral: On line teaching CESARCOM teaching programe (immersive podcasts, digital flashcards)