AnxietyNCT07338747
Educational Video, Anxiety, and Mode of Delivery After Previous Cesarean
A study testing Video-Based Educational Intervention and Standard Verbal Counseling in people with Anxiety and TOLAC, run by Wolfson Medical Center.
Trial summary
This interventional study evaluates whether video-based patient education regarding Trial of Labor After Cesarean (TOLAC) reduces maternal anxiety compared with standard verbal counseling. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anxiety, TOLAC, Previous Cesarean Delivery
- What is being tested?
- Video-Based Educational Intervention and Standard Verbal Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Dec 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
- Pregnant women with a singleton pregnancy.
- History of one previous cesarean delivery with a low transverse uterine incision.
- Eligible for a trial of labor after cesarean (TOLAC) according to clinical assessment and Israeli national clinical guidelines.
- Age 18 years or older.
- Hebrew-speaking.
- Ability and willingness to provide written informed consent.
Who cannot join
- Medical or obstetric conditions contraindicating vaginal delivery, including but not limited to placenta previa or marginal placenta previa.
- History of uterine surgery other than one prior low transverse cesarean section that precludes vaginal delivery.
- History of two or more prior cesarean deliveries.
- Non-vertex fetal presentation or any presentation unsuitable for a trial of labor.
- Multiple gestation.
- Diagnosed severe anxiety disorder or other significant psychiatric disorder that may interfere with participation in the study or completion of questionnaires.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Does an Educational Video Increase Trial of Labor After Cesarean and Reduce Anxiety Among Women With a Prior Cesarean? A Randomized Controlled Trial
This interventional study evaluates whether video-based patient education regarding Trial of Labor After Cesarean (TOLAC) reduces maternal anxiety compared with standard verbal counseling. Pregnant women eligible for TOLAC will be randomized to receive either a structured educational video or routine verbal counseling. Maternal anxiety levels will be assessed using the State-Trait Anxiety Inventory (STAI).
Read the detailed description
Trial of labor after cesarean (TOLAC) is a complex clinical decision that may be associated with significant maternal anxiety. Adequate counseling is essential to support informed decision-making; however, the optimal method for delivering information remains unclear.
This randomized interventional study aims to assess whether video-based patient education can reduce anxiety levels compared with standard verbal counseling. Eligible pregnant women planning delivery after a previous cesarean section will be randomly assigned to one of two study arms: video-based educational counseling or standard verbal counseling.
Anxiety will be measured using the validated State-Trait Anxiety Inventory (STAI) questionnaire after counseling. The results of this study may inform future strategies for patient counseling and shared decision-making in women considering TOLAC.
- Being tested
- Video-Based Educational Intervention, Standard Verbal Counseling
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-Based Educational InterventionBehavioural
A structured educational video providing information on benefits, risks, and expectations of trial of labor after cesarean.
Standard Verbal CounselingOther
Routine verbal counseling provided by the treating clinician regarding trial of labor after cesarean.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Video-Based Patient Education | Experimental | Participants receive structured video-based education regarding trial of labor after cesarean. Receives: Behavioral: Video-Based Educational Intervention |
| Active Comparator: Standard Verbal Counseling | Active comparator | Participants receive standard verbal counseling regarding trial of labor after cesarean. Receives: Other: Standard Verbal Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Anxiety Level
Assessment of maternal anxiety using the State-Trait Anxiety Inventory (STAI) questionnaire.
Measured: Immediately after completion of counseling.
Secondary outcomes (4)
Patient Knowledge Regarding Trial of Labor After Cesarean
Assessment of patient knowledge regarding trial of labor after cesarean, based on a structured questionnaire developed for the study.
Measured: Immediately after completion of counseling.
Rate of Successful Trial of Labor After Cesarean (TOLAC)
Proportion of participants who achieved a successful vaginal birth following a trial of labor after cesarean.
Measured: From delivery.
Patient Satisfaction With Counseling Method
Patient-reported satisfaction with the counseling method received (video-based education or standard verbal counseling), assessed using a Likert-scale questionnaire.
Measured: Immediately after completion of counseling.
Maternal Preference for Trial of Labor After Cesarean Versus Elective Repeat Cesarean Delivery
Participant-reported preference for mode of delivery (trial of labor after cesarean versus elective repeat cesarean delivery) following counseling.
Measured: Immediately after completion of counseling.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Evaluation of the effect of video-based patient education on maternal anxiety levels prior to trial of labor after cesarean.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Shir Lev, MD, Principal investigator, Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338747
- Sponsor's protocol ID
- WOMC-0175-25
- Status last verified
- Jan 2026
- First submitted
- 1 Jan 2026
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does an Educational Video Increase Trial of Labor After Cesarean and Reduce Anxiety Among Women With a Prior Cesarean? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07338747
- Acronym / sponsor ID
- WOMC-0175-25
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- Jan 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 14 Jan 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 interventional study evaluates whether video-based patient education regarding Trial of Labor After Cesarean (TOLAC) reduces maternal anxiety compared with standard verbal counseling. Pregnant women eligible for TOLAC will be randomized to receive either a structured educational video or routine verbal counseling. Maternal anxiety levels will be assessed using the State-Trait Anxiety Inventory (STAI).
Detailed description
Trial of labor after cesarean (TOLAC) is a complex clinical decision that may be associated with significant maternal anxiety. Adequate counseling is essential to support informed decision-making; however, the optimal method for delivering information remains unclear.
This randomized interventional study aims to assess whether video-based patient education can reduce anxiety levels compared with standard verbal counseling. Eligible pregnant women planning delivery after a previous cesarean section will be randomly assigned to one of two study arms: video-based educational counseling or standard verbal counseling.
Anxiety will be measured using the validated State-Trait Anxiety Inventory (STAI) questionnaire after counseling. The results of this study may inform future strategies for patient counseling and shared decision-making in women considering TOLAC.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Evaluation of the effect of video-based patient education on maternal anxiety levels prior to trial of labor after cesarean.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Video-Based Patient Education | Experimental | Behavioral: Video-Based Educational InterventionParticipants receive structured video-based education regarding trial of labor after cesarean. |
| Active Comparator: Standard Verbal Counseling | Active comparator | Other: Standard Verbal CounselingParticipants receive standard verbal counseling regarding trial of labor after cesarean. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pregnant women with a singleton pregnancy.
- History of one previous cesarean delivery with a low transverse uterine incision.
- Eligible for a trial of labor after cesarean (TOLAC) according to clinical assessment and Israeli national clinical guidelines.
- Age 18 years or older.
- Hebrew-speaking.
Key exclusion criteria (6 listed)
- Medical or obstetric conditions contraindicating vaginal delivery, including but not limited to placenta previa or marginal placenta previa.
- History of uterine surgery other than one prior low transverse cesarean section that precludes vaginal delivery.
- History of two or more prior cesarean deliveries.
- Non-vertex fetal presentation or any presentation unsuitable for a trial of labor.
- Multiple gestation.
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 |
|---|---|---|
| Video-Based Educational InterventionA structured educational video providing information on benefits, risks, and expectations of trial of labor after cesarean. | Behavioural | Experimental: Video-Based Patient Education |
| Standard Verbal CounselingRoutine verbal counseling provided by the treating clinician regarding trial of labor after cesarean. | Other | Active Comparator: Standard Verbal Counseling |
Primary outcome
Maternal Anxiety Level
Time frame: Immediately after completion of counseling.
Assessment of maternal anxiety using the State-Trait Anxiety Inventory (STAI) questionnaire.
4 secondary outcomes
Patient Knowledge Regarding Trial of Labor After Cesarean
Time frame: Immediately after completion of counseling.
Rate of Successful Trial of Labor After Cesarean (TOLAC)
Time frame: From delivery.
Patient Satisfaction With Counseling Method
Time frame: Immediately after completion of counseling.
Maternal Preference for Trial of Labor After Cesarean Versus Elective Repeat Cesarean Delivery
Time frame: Immediately after completion of counseling.
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 14 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Shir Lev, MD principal investigator
Wolfson Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Video-Based Educational Intervention and Standard Verbal Counseling in people with Anxiety and TOLAC, run by Wolfson Medical Center.
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 6 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 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Shir Lev, MD (+972504598339, shirlevv@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Anxiety Level (time frame: Immediately after completion of counseling.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2026.