- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07762534
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.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Noa Ben Shoshan, MD
- Номер телефона: +972546842628
- Электронная почта: NOALEGAZIT@GMAIL.COM
Места учебы
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Holon, Израиль
- Wolfson Medical Center
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Контакт:
- Noa Ben Shoshan, MD
- Номер телефона: +972546842628
- Электронная почта: NOALEGAZIT@GMAIL.COM
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Исследования в области здравоохранения
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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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Экспериментальный: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in State Anxiety (ΔSTAI-State)
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Understanding of Medical Information
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Noa Ben Shoshan, MD, Wolfson Medical Center
- Учебный стул: Giulia Bards, MD, Wolfson Medical Center
Публикации и полезные ссылки
Общие публикации
- 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.
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 0083-26-WOMC (Другой идентификатор: WOLFSON MEDICAL CENTER)
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .