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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Noa Ben Shoshan, MD
- 电话号码:+972546842628
- 邮箱:NOALEGAZIT@GMAIL.COM
学习地点
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Holon、以色列
- Wolfson Medical Center
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接触:
- Noa Ben Shoshan, MD
- 电话号码:+972546842628
- 邮箱:NOALEGAZIT@GMAIL.COM
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的: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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实验性的: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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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in State Anxiety (ΔSTAI-State)
大体时间: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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Understanding of Medical Information
大体时间: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
大体时间: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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合作者和调查者
调查人员
- 首席研究员:Noa Ben Shoshan, MD、Wolfson Medical Center
- 学习椅:Giulia Bards, MD、Wolfson Medical Center
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 0083-26-WOMC (其他标识符:WOLFSON MEDICAL CENTER)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
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研究美国 FDA 监管的药品
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