An Informative Video Before Planned External Cephalic Version - Does it Reduce Maternal Anxiety and Improve Chances of Success? - a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- higher success rates.
研究概览
简要总结
A randomized control trial to investigate whether an informative video before planned external cephalic version reduces maternal anxiety and improves chances of success.
详细描述
Women with a breech presentation scheduled to undergo an external cephalic version that meet the criteria are recruited in the Emergency Room by offering every woman that is scheduled to undergo an external cephalic version to participate. Women who agree to participate are asked to sign an inform consent, and are randomized to intervention group and control group. In the Emergency Room sonographic data is collected including amniotic fluid index, engaged presenting part, sonographic and clinical estimation of fetal weight, place of the placenta and various angles between the fetus and the bladder (These data are collected for the study). All participants in the intervention group watches an informative video on recruitment. This video describes in detail the expected external cephalic version process.
Before the external cephalic version and an hour after a successful or an unsuccessful external cephalic version the situation-specific anxiety is measured using the State-Trait Anxiety Inventory score (Attached).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women between ages 18-45
- •with a singleton gestation
- •at gestational week of 36 weeks 0 days until 38 weeks 0 days
- •who admitted labor word for external cephalic version .
排除标准
- •Women who had a past cesarean section
- •Women with oligohydramnios (Amniotic fluid index < 5 cm)
- •Women who had a past external cephalic version
- •Women with a failed external cephalic version in current pregnancy
- •Women who take medication for depression/anxiety disorders
- •Women with a complicated pregnancy including fetal anomalies, polyhydramnios...
研究组 & 干预措施
1. group that watches an informative video
All participants in the intervention group watches an informative video on recruitment. This video describes in detail the expected external cephalic version process.
干预措施: Video (Other)
2. group that does not watch an informative video
this group do not watch an informative video before recruitment
结局指标
主要结局
higher success rates.
时间窗: 4 years
Comparing the percentage of successful External Cephalic Version (ECV) procedures between patients who watched an informative video about the procedure and those who did not receive this intervention.
次要结局
- impact of watching an informative video before external cephalic version on maternal anxiety levels(4 years)