Can a Mobile Application, Contraction Coper, Better Prepare Women in Early Labour and Reduce Emotional Distress for Nulliparous Women? A Randomised Control Trial (the Digi-EL Trial) in a Swedish Sample
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 480
- 试验地点
- 2
- 主要终点
- Emotional distress
研究概览
简要总结
All first-time mothers in Sweden are offered parental support, but local conditions mean that not everyone gets the opportunity to take part in this. Studies show that there is a lack of evidence-based guidelines for the design of parental support in maternal health care. Early labour or latent phase of labour is the part of childbirth were women often feel insecure, in stress and left out from care. First-time mothers who have no experience of one labour before are particularly vulnerable. Many women today use digital applications during pregnancy and in connection with childbirth. There are several digital applications that will help the woman by guiding her and her partner in different decisions about labour, but it is necessary to offer evidence-based, credible electronic and digital solutions for expectant parents. A meta-synthesis from 2018 showed that women use the internet often and the information they receive there has a great influence on their different choices in connection with childbirth. Volume, accessibility, and convenience about digital solutions play a crucial role for women and partners. The digital application Contraction Coper is designed and tested by the company Birth By Heart © in order to facilitate in early labour for the pregnant woman and her partner. The overall purpose of the project is to evaluate whether the application Contraction Coper can contribute to reduced anxiety and stress during pregnancy and childbirth and whether an additional support from a midwife can increase the application use and satisfaction of women when using the application.
A randomized controlled trial is planned where first-time mothers after pregnancy week 25 are invited to participation via social platforms. Participating first-time mothers are randomly assigned to one of three groups; experiment group one, which gets access to the application Contraction Coper, experiment group two Contraction Coper Plus which gets access to both the application and support of midwives, so-called "blended" care, or three, the control group offered customary maternity care only.
Data collection is conducted using questionnaires, mobile application and activity bracelet.
详细描述
The primary outcome is emotional stress in early labour measured with the dimension "Emotional Distress" in the questionnaire Early Labour Experience Questionnaire (ELEQ) Secondary outcomes are Fear of Birth Scale(FOBS), Childbirth Experience Questionnaire (CEQ), used pain relief methods during labour and birth, mode of birth, amount of time used in the application as well as heart rate, sleep and activity for the experimental groups that had activity bracelets in addition.
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
- •First time mothers
- •From pregnancy week
- •Swedish or English spoken.
- •Having a Smartphone, Android or Apple application.
排除标准
- •°Multiparas.
研究组 & 干预措施
Control
Conventional antenatal care.
Contraction Coper
The digital application Contraction Coper is provided from pregnancy week 25. The application contains two different modules. One is an informational module about the method (about 60 minutes), the other is a contraction module to be used in early labour (in total 6 hours).
干预措施: Contraction Coper (Other)
Contraction Coper Plus
The digital application Contraction Coper with additionally support from a midwife in two different occasions during pregnancy.
干预措施: Contraction Coper (Other)
Contraction Coper Plus
The digital application Contraction Coper with additionally support from a midwife in two different occasions during pregnancy.
干预措施: Contraction Coper Plus (Other)
结局指标
主要结局
Emotional distress
时间窗: "Group differences at 1 month after birth"
The subscale Emotional distress from Early Labour Experience Questionnaire (ELEQ) will be used for measure. Emotional distress scale is assessed on a five point Likert scale 1-5. Minimum score 6 and maximum score is 30. A higher score represents more distress during early labour.
次要结局
- Support from birth companion("Group differencies at1 month after birth")
- Fear of birth in potential future birth(" Group differencies at 1 month after birth")
- Childbirth Self-Efficacy Inventory before childbirth("Assessed during pregnancy week 25 up till week 36 at consent to the study")
- Fear of birth("Assesed during pregnancy week 25 up till week 36 at consent to the study")
- Childbirth Self-Efficacy Inventory after childbirth("Group differencies at1 month after birth")
- Childbirth experience("Group differencies at 1 month after birth")
- Sense of coherence("Assessed during pregnancy week 25 up till week 36 at consent to the study")
- Activity bracelet FitBit("At the timepoint were contractions startsduring early labour and until the baby is born")
- Activity bracelet FitBit("At the timepoint were contractions starts during early labour and until the baby is born")