Physician vs Artificial Intelligence Counseling Before Elective Cesarean Delivery: A Randomized Controlled Trial

NCT07762534 | Not Yet Recruiting

• 1 other identifier: 0083-26-WOMC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cesarean Section; Informed Consent; Anxiety

Keywords

Elective Cesarean Delivery; Cesarean Section; Artificial Intelligence; AI Counseling; Informed Consent; Preoperative Counseling; Patient Education; Anxiety; STAI; Shared Decision Making; Patient Satisfaction; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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).

  Immediately before counseling and immediately after counseling during the same study visit.

Secondary Outcomes (2)

• Understanding of Medical Information

  Immediately after counseling during the study visit.

• Satisfaction With the Counseling Process

  Immediately after counseling during the study visit.

Study Arms (2)

Standard Physician Counseling

EXPERIMENTAL

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

AI-Based Counseling

EXPERIMENTAL

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

Interventions

Physician-Delivered Counseling OTHER

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.

Standard Physician Counseling

AI-Based Counseling OTHER

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.

AI-Based Counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18 years or older
• Singleton pregnancy
• Third trimester of pregnancy
• Scheduled for elective cesarean delivery
• Full proficiency in written and spoken Hebrew

You may not qualify if:

• 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
• Multiple gestation pregnancy
• Known fetal anomaly or significant fetal pathology diagnosed before delivery

Sponsors & Collaborators

• Wolfson Medical Center: lead

Study Sites (1)

Wolfson medical center

Holon, Israel

Location

Related Publications (3)

• Rose SL, Shapiro D. An Ethically Supported Framework for Determining Patient Notification and Informed Consent Practices When Using Artificial Intelligence in Health Care. Chest. 2024 Sep;166(3):572-578. doi: 10.1016/j.chest.2024.04.014. Epub 2024 May 22.

  PMID: 38788895 BACKGROUND

• Schnitman G, Wang T, Kundu S, Turkdogan S, Gotlieb R, How J, Gotlieb W. The role of digital patient education in maternal health: A systematic review. Patient Educ Couns. 2022 Mar;105(3):586-593. doi: 10.1016/j.pec.2021.06.019. Epub 2021 Jun 24.

  PMID: 34183217 BACKGROUND

• Abuzaid M, Alshahrani MS, Ahmed AM, Moafa MN, Alomar O, O'Mahony A, Abu-Zaid A. Effectiveness of preoperative multimedia educational sessions on the levels of anxiety and satisfaction among women undergoing cesarean: a systematic review and meta-analysis. Women Health. 2024 May-Jun;64(5):416-426. doi: 10.1080/03630242.2024.2349560. Epub 2024 May 5.

  PMID: 38706246 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Patient Satisfaction

Condition Hierarchy (Ancestors)

Mental Disorders; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Noa Ben Shoshan, MD

  Wolfson Medical Center

  PRINCIPAL INVESTIGATOR

• Giulia Bards, MD

  Wolfson Medical Center

  STUDY CHAIR

Central Study Contacts

Noa Ben Shoshan, MD

CONTACT

+972546842628; NOALEGAZIT@GMAIL.COM

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: OB/GYN Resident, Department of Obstetrics and Gynecology, Principal Investigator

Model Details: Participants will be randomized in a 1:1 ratio to one of two parallel study arms. The first arm will receive standard preoperative counseling regarding elective cesarean delivery from an experienced obstetrician-gynecologist. The second arm will receive standardized preoperative counseling delivered through an artificial intelligence (AI)-based system. The medical content provided in both arms will be as similar as possible, with the method of information delivery serving as the primary variable under investigation.

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: August 13, 2026
• Study Start (Estimated): August 20, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 13, 2026

Record last verified: 2026-08

Locations

IL (1)