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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWolfson Medical Center

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Physician-Delivered Counseling

    Other intervention

    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.

  • AI-Based Counseling

    Other intervention

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Standard Physician CounselingExperimental treatment 1 intervention
Group B: AI-Based CounselingExperimental treatment 1 intervention

Trial outcomes

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).

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

Secondary outcomes

1

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.
2

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.

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: