Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
NCT07137377

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

Led by University Hospital, Geneva · Updated on 2025-08-22

260

Participants Needed

1

Research Sites

119 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older
  • Elective cesarean section planned at Geneva University Hospitals Maternity Unit
  • Consent to participate in the study
Not Eligible

You will not qualify if you...

  • Patients who do not speak French and require an interpreter
  • Emergency cesarean sections
  • Death during the intervention

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Trial Site Locations

Total: 1 location

1

HUG

Geneva, Switzerland, 1205

Actively Recruiting

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Research Team

O

Océane Pécheux

CONTACT

M

Mélissa Vocat

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

PREVENTION

Number of Arms

2

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