CompletedNot Applicable

Daring Birth - Digital Coaching Solution to Improve Childbirth Experience

Finland200 participantsStarted 2024-02-16

Plain-language summary

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.

Who can participate

Age range

18 Years – 60 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Nulliparous status Estimated time of delivery (ETD) between 15.5. 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 Exclusion Criteria: * Referral to a fetal medicine unit Diagnosed psychotic or bipolar disorders Active substance abuse Participation in another clinical study focusing on perinatal mental health

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Childbirth experience Visual Analogue Scale

Timeframe: measured at 3 and 5 weeks postpartum

Wijma Delivery Experience Questionnaire

Timeframe: measured at 3 weeks postpartum

Trial details

NCT IDNCT06585839

SponsorAalto University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31

View on ClinicalTrials.gov More Childbirth Problems trials