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

NCT07137377 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2025-08-22

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

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

A short e-learning program (immersive podcasts, digital flashcards) will be carried out for the medical and paramedical staff of the cesarean section operating room, by a specialized team. It will will consist of : * the presentation of the basic principles of therapeutic communication (listening, empathy, verbal, non-verbal, paraverbal language) * the distribution of the "HUG communication lexicon/wordbook" . * educational scenes illustrating the impact of therapeutic communication in the operating room ("good" versus "bad" words).

Sponsors & Collaborators

  • University Hospital, Geneva

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-14
Primary Completion
2027-07-31
Completion
2027-07-31

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07137377 on ClinicalTrials.gov