Does an Educational Video Increase Trial of Labor After Cesarean and Reduce Anxiety Among Women With a Prior Cesarean? A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 主要终点
- Maternal Anxiety Level
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Experimental: Video-Based Patient Education
Participants receive structured video-based education regarding trial of labor after cesarean.
干预措施: Video-Based Educational Intervention (Behavioral)
Active Comparator: Standard Verbal Counseling
Participants receive standard verbal counseling regarding trial of labor after cesarean.
干预措施: Standard Verbal Counseling (Other)
结局指标
主要结局
Maternal Anxiety Level
时间窗: Immediately after completion of counseling.
Assessment of maternal anxiety using the State-Trait Anxiety Inventory (STAI) questionnaire.
次要结局
- Patient Knowledge Regarding Trial of Labor After Cesarean(Immediately after completion of counseling.)
- Rate of Successful Trial of Labor After Cesarean (TOLAC)(From delivery.)
- Patient Satisfaction With Counseling Method(Immediately after completion of counseling.)
- Maternal Preference for Trial of Labor After Cesarean Versus Elective Repeat Cesarean Delivery(Immediately after completion of counseling.)