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

Not Applicable

Recruiting

• Conditions: Communication; Anxiety

• Registration Number: NCT07137377
• Lead Sponsor: University Hospital, Geneva

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-04-14
• Status Verified: 2025-08
• Study First Submitted: 2025-08-12
• Study First Submitted QC: 2025-08-20
• Last Update Submitted: 2025-08-20
• Study First Posted: 2025-08-22
• Last Update Posted: 2025-08-22
• Primary Completion: 2027-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 260

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Post elective cesarean anxiety level	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.

Secondary Outcome Measures

Name	Time	Method
High anxiety levels proportion	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.
Providers satisfaction	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)

Trial Locations

Locations (1)

HUG; 🇨🇭 Geneva, Switzerland