About this trial
This randomized controlled trial will compare two methods of providing preoperative counseling before elective cesarean delivery: counseling by an obstetrician-gynecologist and counseling delivered through an artificial intelligence (AI)-based system. The study aims to evaluate the effects of these counseling methods on patients' anxiety levels, understanding of medical information, and satisfaction with the counseling process.
Women scheduled for elective cesarean delivery will be randomly assigned to receive either standard physician counseling or AI-based counseling containing the same medical information. Anxiety, knowledge, and satisfaction will be assessed using questionnaires before and after counseling.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women aged 18 years or older
Singleton pregnancy
Third trimester of pregnancy
Scheduled for elective cesarean delivery
Disqualifiers
Non-elective cesarean delivery (urgent or emergency cesarean delivery) that does not allow completion of the counseling process and study questionnaires
Known anxiety disorder or depression
Cognitive impairment
Insufficient Hebrew language proficiency to independently complete study questionnaires
Trial design
Parallel
Treatments tested in this trial
Physician-Delivered Counseling
Other interventionA complete preoperative counseling session regarding elective cesarean delivery provided by an experienced obstetrician-gynecologist according to departmental standard practice. Counseling includes information regarding the procedure, anesthesia, risks, benefits, alternatives, and recovery.
AI-Based Counseling
Other interventionA standardized preoperative counseling session regarding elective cesarean delivery delivered through an artificial intelligence (AI)-based system. The counseling provides information regarding the procedure, anesthesia, risks, benefits, alternatives, and recovery. The medical content is intended to be as similar as possible to that provided in the physician counseling arm.
Treatment groups
Trial outcomes
Primary outcomes
Change in State Anxiety (ΔSTAI-State)
Change in anxiety level measured by the State-Trait Anxiety Inventory-State (STAI-State), calculated as the difference between the post-counseling score (T2) and the pre-counseling score (T1).
Secondary outcomes
Understanding of Medical Information
Participant understanding of information related to elective cesarean delivery, assessed using an 8-item knowledge questionnaire completed after counseling.
Satisfaction With the Counseling Process
Participant satisfaction with the counseling process, assessed using a Likert-scale questionnaire evaluating the subjective experience and satisfaction with the information provided.
Sponsors and contacts
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