Daring Birth - Digital Coaching Solution to Improve Childbirth Experience
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Childbirth experience Visual Analogue Scale
研究概览
简要总结
The aim of the study is to investigate the effectiveness of the Daring Birth digital coaching solution (the Natal Mind app) in enhancing the experience of childbirth. Natal Mind is designed for mobile phones and features a unique blend of emotion tracking, avatar-based interaction, and mass-customized psychoeducation and exercises. These features collectively work to improve the childbirth experience, alleviate pain experience during labor, and mitigate perinatal mental health (PMH) issues namely fear of childbirth (FOC), anxiety, and postpartum depression. The primary outcome of this study is the improvement of the childbirth experience, as it has been recognized to be a fundamental step in preventing postpartum problems.
The study uses a randomized controlled trial (RCT) with two arms: an intervention arm, where participants will have access to the Natal Mind app with its full functionalities, and a control arm, where participants use the app only for answering the study questionnaires while receiving standard care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Nulliparous status Estimated time of delivery (ETD) between 15.
- •and 15.9.2024 Between 20 and 28 weeks gestational age at the time of recruitment Fluency in Finnish Intended maternity care and birth hospital located in Finland Aged 18 or above
排除标准
- •Referral to a fetal medicine unit Diagnosed psychotic or bipolar disorders Active substance abuse Participation in another clinical study focusing on perinatal mental health
结局指标
主要结局
Childbirth experience Visual Analogue Scale
时间窗: measured at 3 and 5 weeks postpartum
Visual Analogue Scale (VAS) for childbirth experience (min 0, max 10; higher scores mean better outcome)
Wijma Delivery Experience Questionnaire
时间窗: measured at 3 weeks postpartum
Childbirth experience W-DEQ-B (Wijma Delivery Experience Questionnaire) (min 0, max 165; higher scores mean better outcome)
次要结局
- Fear of childbirth Visual Analogue Scale(measured at baseline, at 30-32 weeks of gestation, and at 35-37 weeks of gestation)
- Edinburgh Postnatal Depression Scale(measured at 5 weeks postpartum)
- Wijma Delivery Expectancy Questionnaire(measured at 30-32 weeks of gestation)
- Labor pain Visual Analogue Scale(measured at birth and at 5 weeks postpartum)
- Generalized Anxiety Disorder(measured at baseline, at 35-37 weeks of gestation, and at 5 weeks postpartum)