BMC pregnancy and childbirth · 2025
CESARCOM study protocol: assessing the impact of therapeutic communication on patients' anxiety during elective cesarean sections, - a before-and-after interventional study.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Pécheux Océane, Vocat Mélissa, Coen Matteo, de Oliveira Sara, Bouscail Hardy Anne-Lise, Jaksic Cyril, Silvestrini Nicolas, Campelo Sonia, Othenin-Girard Véronique, Montandon-La-Longe Corine-Yara, Chilin Antonina, Suppan Mélanie, Al Khoury Al Kallab Rita, Daelemans Caroline
Аннотация
BACKGROUND: Anxiety is common prior to elective caesarean sections and may negatively affect anesthesia outcomes, postoperative pain management, and maternal mental health. Pharmacological premedication remains controversial, prompting growing interest in non-pharmacological alternatives. Hypnosis-based therapeutic communication, which is founded on empathy and the use of positive verbal and non-verbal language, as well as the conscious avoidance of negative or anxiety-inducing suggestions, has shown promise in other surgical settings. However, its effectiveness in obstetrics has yet to be explored.
METHODS: This is a single-centre, prospective, before-and-after study. The study aims to assess whether implementing an on-line (asynchronous) training program on hypnosis-based therapeutic communication for obstetric care teams can reduce maternal anxiety following elective caesarean sections. The study will include two cohorts of 130 patients each: one enrolled before the intervention and one after; both blinded of the intervention phase. 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 (State-Trait Anxiety Inventory score > 45), as well as staff satisfaction, and indicators of the feasibility of implementing the training. The intervention consists of a brief (<1 hour) training module using podcasts and flashcards, combined with distributing a wordbook that promotes HBTC. Staff participation 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 hypnosis-based therapeutic communication training program 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.
TRIAL REGISTRATION: ClinicalTrials.gov, TRN: NCT07137377, Registration date: 22 August 2025.
METHODS: This is a single-centre, prospective, before-and-after study. The study aims to assess whether implementing an on-line (asynchronous) training program on hypnosis-based therapeutic communication for obstetric care teams can reduce maternal anxiety following elective caesarean sections. The study will include two cohorts of 130 patients each: one enrolled before the intervention and one after; both blinded of the intervention phase. 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 (State-Trait Anxiety Inventory score > 45), as well as staff satisfaction, and indicators of the feasibility of implementing the training. The intervention consists of a brief (<1 hour) training module using podcasts and flashcards, combined with distributing a wordbook that promotes HBTC. Staff participation 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 hypnosis-based therapeutic communication training program 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.
TRIAL REGISTRATION: ClinicalTrials.gov, TRN: NCT07137377, Registration date: 22 August 2025.