Cesarean SectionCAI-CSNCT07762534
Physician vs Artificial Intelligence Counseling Before Elective Cesarean Delivery: A Randomized Controlled Trial
A study testing Physician-Delivered Counseling and AI-Based Counseling in people with Cesarean Section and Informed Consent, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section, Informed Consent, Anxiety
- What is being tested?
- Physician-Delivered Counseling and AI-Based Counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Aug 2026to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18 years or older
- Singleton pregnancy
- Third trimester of pregnancy
- Scheduled for elective cesarean delivery
- Full proficiency in written and spoken Hebrew
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site
Wolfson medical center
Holon
Noa Ben Shoshan, MD, +972546842628, NOALEGAZIT@GMAIL.COM
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Cesarean Section, Informed Consent, Anxiety
- Being tested
- Physician-Delivered Counseling, AI-Based Counseling
- Keywords
- Elective Cesarean Delivery, Cesarean Section, Artificial Intelligence, AI Counseling, Informed Consent, Preoperative Counseling, Patient Education, Anxiety, STAI, Shared Decision Making, Patient Satisfaction, Randomized Controlled Trial
- Medical subject headings
- Anxiety Disorders, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician-Delivered CounselingOther
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 CounselingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Physician Counseling | Experimental | 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. Receives: Other: Physician-Delivered Counseling |
| AI-Based Counseling | Experimental | 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. Receives: Other: AI-Based Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Immediately before counseling and immediately after counseling during the same study visit.
Secondary outcomes (2)
Understanding of Medical Information
Participant understanding of information related to elective cesarean delivery, assessed using an 8-item knowledge questionnaire completed after counseling.
Measured: Immediately after counseling during the study visit.
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.
Measured: Immediately after counseling during the study visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start20 Aug 2026 (estimated)
- Primary completion30 Jul 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to one of two parallel study arms. The first arm will receive standard preoperative counseling regarding elective cesarean delivery from an experienced obstetrician-gynecologist. The second arm will receive standardized preoperative counseling delivered through an artificial intelligence (AI)-based system. The medical content provided in both arms will be as similar as possible, with the method of information delivery serving as the primary variable under investigation.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, noa ben shoshan, Wolfson Medical Center
- Investigators
- Noa Ben Shoshan, MD, Principal investigator, Wolfson Medical CenterGiulia Bards, MD, Study chair, Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07762534
- Sponsor's protocol ID
- 0083-26-WOMC
- Other IDs
- 0083-26-WOMC
- Acronym
- CAI-CS
- Status last verified
- Aug 2026
- First submitted
- 24 Jun 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
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.
PubMed 38788895Schnitman 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.
PubMed 34183217Abuzaid 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.
PubMed 38706246
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Physician-Provided Versus Artificial Intelligence-Based Preoperative Counseling Before Elective Cesarean Delivery
- ClinicalTrials.gov ID
- NCT07762534
- Acronym / sponsor ID
- CAI-CS / 0083-26-WOMC
- Conditions
- Cesarean Section, Informed Consent, Anxiety
- Keywords
- Elective Cesarean Delivery, Cesarean Section, Artificial Intelligence, AI Counseling, Informed Consent, Preoperative Counseling, Patient Education, Anxiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to one of two parallel study arms. The first arm will receive standard preoperative counseling regarding elective cesarean delivery from an experienced obstetrician-gynecologist. The second arm will receive standardized preoperative counseling delivered through an artificial intelligence (AI)-based system. The medical content provided in both arms will be as similar as possible, with the method of information delivery serving as the primary variable under investigation.
| Arm | Type | Receives |
|---|---|---|
| Standard Physician Counseling | Experimental | Other: Physician-Delivered CounselingParticipants 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. |
| AI-Based Counseling | Experimental | Other: AI-Based CounselingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women aged 18 years or older
- Singleton pregnancy
- Third trimester of pregnancy
- Scheduled for elective cesarean delivery
- Full proficiency in written and spoken Hebrew
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physician-Delivered CounselingA 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. | Other | Standard Physician Counseling |
| AI-Based CounselingA 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. | Other | AI-Based Counseling |
Primary outcome
Change in State Anxiety (ΔSTAI-State)
Time frame: 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).
2 secondary outcomes
Understanding of Medical Information
Time frame: Immediately after counseling during the study visit.
Satisfaction With the Counseling Process
Time frame: Immediately after counseling during the study visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Background: PubMed 38788895Rose 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.
- Background: PubMed 34183217Schnitman 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.
- Background: PubMed 38706246Abuzaid 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.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Noa Ben Shoshan, MD principal investigator
Wolfson Medical Center
Giulia Bards, MD study chair
Wolfson Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physician-Delivered Counseling and AI-Based Counseling in people with Cesarean Section and Informed Consent, run by Wolfson Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noa Ben Shoshan, MD (+972546842628, NOALEGAZIT@GMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in State Anxiety (ΔSTAI-State) (time frame: Immediately before counseling and immediately after counseling during the same study visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07762534, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.