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

August 20, 2025 updated by: Océane Pécheux, University Hospital, Geneva

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post elective cesarean anxiety level
Time Frame: Within 24 hours after cesarean.

To assess the impact of a therapeutic communication wordbook and hypnosis-based therapeutic communication teaching programme on patients' anxiety levels after elective c-section and the proportion of elevated anxiety levels after elective c-sections, before and after implementation of a therapeutic communication protocol/short teaching programme.

Patients' will receive State-State Anxiety Inventory (STAI) scores by email and complete them on line. Their result will be directly transfer to REDCap, data management software.

We will report difference of means of the post c-section anxiety assessed with the STAI score (as a continuous variable), each patient result being adjusted on its pre c-section STAI score (result at baseline).

Minimum STAI score result=20; maximum=80. The higher the score, the greater the level of anxiety.
Within 24 hours after cesarean.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
High anxiety levels proportion
Time Frame: Within the 24 hours after cesareans.
Differences of proportions of patients with a post- c-section State Anxiety Inventory (STAI-S) score > 45 in the two groups, and to assess the providers satisfaction with the teaching programme, as long as the feasibility of implementing such a programme in obstetrics.
Within the 24 hours after cesareans.
Providers satisfaction
Time Frame: At 6 and 12 months after the programme
The satisfaction of the team (comprising nurses, midwives, doctors, and residents) will be measured using Likert scales (minimum result=10; maximum=50; the higher is the score, the greater the level of satisfaction)
At 6 and 12 months after the programme

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2025

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

August 12, 2025

First Submitted That Met QC Criteria

August 20, 2025

First Posted (Actual)

August 22, 2025

Study Record Updates

Last Update Posted (Actual)

August 22, 2025

Last Update Submitted That Met QC Criteria

August 20, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID 2024-02495
  • PRD 05-2024-II (Other Grant/Funding Number: Research and development Fund - University Hospitals of Geneva)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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