A Randomized Controlled Trial Comparing Physician-Provided Versus Artificial Intelligence-Based Preoperative Counseling Before Elective Cesarean Delivery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Wolfson Medical Center
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change in State Anxiety (ΔSTAI-State)
Study Overview
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women aged 18 years or older
- •Singleton pregnancy
- •Third trimester of pregnancy
- •Scheduled for elective cesarean delivery
- •Full proficiency in written and spoken Hebrew
Exclusion Criteria
- •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
Arms & Interventions
Standard Physician Counseling
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.
Intervention: Physician-Delivered Counseling (Other)
AI-Based 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.
Intervention: AI-Based Counseling (Other)
Outcomes
Primary Outcomes
Change in State Anxiety (ΔSTAI-State)
Time Frame: Immediately before counseling and immediately after counseling during the same study visit.
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(Immediately after counseling during the study visit.)
- Satisfaction With the Counseling Process(Immediately after counseling during the study visit.)
Investigators
noa ben shoshan
OB/GYN Resident, Department of Obstetrics and Gynecology, Principal Investigator
Wolfson Medical Center