An interventional study of Physician-Delivered Counseling and AI-Based Counseling in Cesarean Section, Informed Consent and Anxiety, sponsored by Wolfson Medical Center. Not yet recruiting at 1 site in Israel. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Wolfson Medical Center · Not applicable, Interventional, and Health services research
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.
Cesarean delivery is one of the most common surgical procedures in obstetrics, with rates increasing worldwide. Informed consent before elective cesarean delivery requires clear and comprehensive communication regarding the procedure, potential risks and benefits, alternatives, and postoperative recovery. Effective counseling is an important component of patient-centered care and may influence patient understanding, satisfaction, and anxiety.
Digital technologies are increasingly being used to improve the accessibility, consistency, and quality of patient education. Artificial intelligence (AI)-based systems have the potential to provide standardized medical information in a clear and accessible format. However, there is currently limited evidence regarding the impact of AI-based counseling compared with traditional physician-delivered counseling in the setting of elective cesarean delivery.
The purpose of this randomized controlled trial is to compare two methods of preoperative counseling before elective cesarean delivery: standard counseling provided by an obstetrician-gynecologist and counseling delivered through an AI-based system. The study will evaluate the effect of these counseling methods on patient anxiety, understanding of medical information, and satisfaction with the counseling process.
Eligible participants will be women scheduled for elective cesarean delivery who attend a dedicated preoperative clinic. After providing informed consent for study participation, participants will be randomly assigned in a 1:1 ratio to receive either physician-delivered counseling or AI-based counseling. The medical content provided in both study arms will be as similar as possible, with the method of information delivery serving as the primary variable under investigation.
Anxiety levels will be assessed before and after counseling using the State-Trait Anxiety Inventory-State (STAI-State). Following counseling, participants will complete questionnaires assessing knowledge and satisfaction. All participants will have the opportunity to ask additional questions after receiving the assigned counseling intervention to ensure adequate understanding of the planned procedure.
This study seeks to generate evidence regarding the potential role of AI-based counseling as an alternative or complementary approach to traditional preoperative counseling for elective cesarean delivery.
7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's planned enrollment of 50 is below the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Wolfson Medical Center is the lead sponsor of 118 studies on the registry; 17 are open to participants now.
Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
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Exclusion Criteria:
Participants assigned to this arm will receive a complete preoperative counseling session regarding elective cesarean delivery from an experienced obstetrician-gynecologist, according to departmental standard practice. The counseling will include information regarding the procedure, anesthesia, potential risks and benefits, recovery, and alternatives.
Other: Physician-Delivered Counseling
Participants assigned to this arm will receive standardized preoperative counseling regarding elective cesarean delivery through an artificial intelligence (AI)-based system. The counseling will provide information regarding the procedure, anesthesia, potential risks and benefits, recovery, and alternatives. The medical content will be as similar as possible to that provided in the physician counseling arm.
Other: AI-Based Counseling
A 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.
A 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.
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).
Time frame: Immediately before counseling and immediately after counseling during the same study visit.
Understanding of Medical Information
Participant understanding of information related to elective cesarean delivery, assessed using an 8-item knowledge questionnaire completed after counseling.
Time frame: Immediately after counseling during the study visit.
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.
Time frame: Immediately after counseling during the study visit.
Plan to share: Undecided — Individual participant data (IPD) sharing plans have not yet been determined. Any future data sharing will be considered in accordance with institutional policies, ethical approvals, participant privacy protections, and applicable regulations.
Start is estimated for Aug 2026; primary completion for Jul 2027, 11 months later.
Of 3,836 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's planned 11 months is close to that.
Counting every sponsor, half of 3,938 studies reached it within 12 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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