Ignite Creation Date:
2024-05-06 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05122390
Status:
COMPLETED
Last Update Posted:
2023-10-26
First Post:
2021-09-23
Brief Title:
DIGItal Early Labour A Digital Application for Coping in Early Phase of Labour
Sponsor:
Värmland County Council Sweden
Organization:
Värmland County Council Sweden
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIGI-EL
Brief Summary:
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
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
Detailed Description:
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 ScaleFOBS 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None