HUG
Geneva, 1205, Switzerland
Location status: Recruiting
Location contact
Mélissa Vocat
CONTACT
Oceane Pécheux
CONTACT
NCT Number: NCT07137377
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Geneva, 1205, Switzerland
Location status: Recruiting
Mélissa Vocat
CONTACT
Oceane Pécheux
CONTACT
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-≥18 years
Exclusion criteria
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 :
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.
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.
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)
Contact information is provided by the study sponsor or research team.
Mélissa Vocat
CONTACT
Océane Pécheux
CONTACT
University Hospital, Geneva
Other
CESARCOM Study Protocol: Assessing the Impact of Therapeutic Communication on Patients' Anxiety During Elective Cesarean Sections, - a Before-and-after Interventional Study
Acronym: CESARCOM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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