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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07137377
Acronym
CESARCOM
Enrollment
260
Registered
2025-08-22
Start date
2025-04-14
Completion date
2027-07-31
Last updated
2025-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Communication

Keywords

hypnosis based therapeutic communication, anxiety, STAI score

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.

Interventions

BEHAVIORALOn 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

University Hospital, Geneva
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Patients' do not know if they are in the pre intervention group or in the post intervention group. The statistician will not know which is the pre or the post intervention group either.

Intervention model description

Patients' anxiety before and after a teaching programme of the providers.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Post elective cesarean anxiety levelWithin 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.

Secondary

MeasureTime frameDescription
High anxiety levels proportionWithin 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.
Providers satisfactionAt 6 and 12 months after the programmeThe 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)

Countries

Switzerland

Contacts

Primary ContactOcéane Pécheux
oceane.pecheux@hug.ch+41795535095
Backup ContactMélissa Vocat
melissa.vocat@hug.ch+41795532284

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026