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Physician vs Artificial Intelligence Counseling Before Elective Cesarean Delivery: A Randomized Controlled Trial (CAI-CS)

8. August 2026 aktualisiert von: noa ben shoshan, Wolfson Medical Center

A Randomized Controlled Trial Comparing Physician-Provided Versus Artificial Intelligence-Based Preoperative Counseling Before Elective Cesarean Delivery

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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

50

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

      • Holon, Israel
        • Wolfson Medical Center
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
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.
Experimental: 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.
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in State Anxiety (ΔSTAI-State)
Zeitfenster: 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).
Immediately before counseling and immediately after counseling during the same study visit.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Understanding of Medical Information
Zeitfenster: Immediately after counseling during the study visit.
Participant understanding of information related to elective cesarean delivery, assessed using an 8-item knowledge questionnaire completed after counseling.
Immediately after counseling during the study visit.
Satisfaction With the Counseling Process
Zeitfenster: Immediately after counseling during the study visit.
Participant satisfaction with the counseling process, assessed using a Likert-scale questionnaire evaluating the subjective experience and satisfaction with the information provided.
Immediately after counseling during the study visit.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Noa Ben Shoshan, MD, Wolfson Medical Center
  • Studienstuhl: Giulia Bards, MD, Wolfson Medical Center

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

20. August 2026

Primärer Abschluss (Geschätzt)

30. Juli 2027

Studienabschluss (Geschätzt)

1. August 2027

Studienanmeldedaten

Zuerst eingereicht

24. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. August 2026

Zuerst gepostet (Tatsächlich)

13. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

13. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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