Physician vs Artificial Intelligence Counseling Before Elective Cesarean Delivery: A Randomized Controlled Trial (CAI-CS)
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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Noa Ben Shoshan, MD
- 電話番号:+972546842628
- メール:NOALEGAZIT@GMAIL.COM
研究場所
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Holon、イスラエル
- Wolfson Medical Center
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コンタクト:
- Noa Ben Shoshan, MD
- 電話番号:+972546842628
- メール:NOALEGAZIT@GMAIL.COM
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:ヘルスサービス研究
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的: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.
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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.
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実験的: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.
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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.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in State Anxiety (ΔSTAI-State)
時間枠:Immediately before counseling and immediately after counseling during the same study visit.
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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).
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Immediately before counseling and immediately after counseling during the same study visit.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Understanding of Medical Information
時間枠:Immediately after counseling during the study visit.
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Participant understanding of information related to elective cesarean delivery, assessed using an 8-item knowledge questionnaire completed after counseling.
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Immediately after counseling during the study visit.
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Satisfaction With the Counseling Process
時間枠:Immediately after counseling during the study visit.
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Participant satisfaction with the counseling process, assessed using a Likert-scale questionnaire evaluating the subjective experience and satisfaction with the information provided.
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Immediately after counseling during the study visit.
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Noa Ben Shoshan, MD、Wolfson Medical Center
- スタディチェア:Giulia Bards, MD、Wolfson Medical Center
出版物と役立つリンク
一般刊行物
- 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.
- 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.
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 0083-26-WOMC (その他の識別子:WOLFSON MEDICAL CENTER)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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