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

Official title

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

Overview

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

• 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 oper

Primary outcome measures

• Post elective cesarean anxiety level [Time frame: Within 24 hours after cesarean.]

Secondary outcome measures (2)

• High anxiety levels proportion [Time frame: Within the 24 hours after cesareans.]
• Providers satisfaction [Time frame: At 6 and 12 months after the programme]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Sequential

Masking

Double blind

Primary purpose

Prevention

Study locations

Switzerland · 1 center

• HUG — Geneva

Publications

• Gaudry E, Vagg P, Spielberger CD. Validation of the State-Trait Distinction in Anxiety Research. Multivariate Behav Res. 1975 Jul 1;10(3):331-41. doi: 10.1207/s15327906mbr1003_6. PMID 26829634
• Lang EV, Hatsiopoulou O, Koch T, Berbaum K, Lutgendorf S, Kettenmann E, Logan H, Kaptchuk TJ. Can words hurt? Patient-provider interactions during invasive procedures. Pain. 2005 Mar;114(1-2):303-9. doi: 10.1016/j.pain.2004.12.028. Epub 2005 Jan 26. PMID 15733657
• Caddick J, Jawad S, Southern S, Majumder S. The power of words: sources of anxiety in patients undergoing local anaesthetic plastic surgery. Ann R Coll Surg Engl. 2012 Mar;94(2):94-8. doi: 10.1308/003588412X13171221501267. PMID 22391371
• Varga K. Suggestive techniques connected to medical interventions. Interv Med Appl Sci. 2013 Sep;5(3):95-100. doi: 10.1556/IMAS.5.2013.3.1. Epub 2013 Sep 16. PMID 24265898
• Boselli E, Demaille N, Fuchs G, Manseur A. [Assessment of the therapeutic communication in order to improve the welcoming of patients in the operating room: impact study]. Can J Anaesth. 2018 Oct;65(10):1138-1146. doi: 10.1007/s12630-018-1167-2. Epub 2018 Jun 11. French. PMID 29949092
• Wilson CJ, Mitchelson AJ, Tzeng TH, El-Othmani MM, Saleh J, Vasdev S, LaMontagne HJ, Saleh KJ. Caring for the surgically anxious patient: a review of the interventions and a guide to optimizing surgical outcomes. Am J Surg. 2016 Jul;212(1):151-9. doi: 10.1016/j.amjsurg.2015.03.023. Epub 2015 Jun 2. PMID 26138522
• Hishikawa K, Kusaka T, Fukuda T, Kohata Y, Inoue H. Anxiety or Nervousness Disturbs the Progress of Birth Based on Human Behavioral Evolutionary Biology. J Perinat Educ. 2019 Oct 1;28(4):218-223. doi: 10.1891/1058-1243.28.4.218. PMID 31728113
• Kassahun WT, Mehdorn M, Wagner TC, Babel J, Danker H, Gockel I. The effect of preoperative patient-reported anxiety on morbidity and mortality outcomes in patients undergoing major general surgery. Sci Rep. 2022 Apr 15;12(1):6312. doi: 10.1038/s41598-022-10302-z. PMID 35428818

Identifiers

NCT: NCT07137377 · ID 2024-02495 · PRD 05-2024-II

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗