Daring Birth - Digital Coaching Solution to Improve Childbirth Experience

Not Applicable

Completed

• Conditions: Childbirth Problems; Perinatal Depression; Anxiety in Pregnancy; Pregnancy Related; Postpartum Depression; Postpartum Anxiety; Fear of Childbirth

• Registration Number: NCT06585839
• Lead Sponsor: Aalto University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-16
• Study First Submitted: 2024-08-16
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-03
• Study First Posted: 2024-09-19
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Childbirth experience Visual Analogue Scale	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	measured at 3 weeks postpartum	Childbirth experience W-DEQ-B (Wijma Delivery Experience Questionnaire) (min 0, max 165; higher scores mean better outcome)

Secondary Outcome Measures

Name	Time	Method
Fear of childbirth Visual Analogue Scale	measured at baseline, at 30-32 weeks of gestation, and at 35-37 weeks of gestation	Visual Analogue Scale (VAS) for fear of childbirth (FOC) (min 0, max 10; higher scores mean worse outcome)
Edinburgh Postnatal Depression Scale	measured at 5 weeks postpartum	Postpartum depression measured with Edinburgh Postnatal Depression Scale (EPDS) (min 0, max 30; higher scores mean worse outcome)
Wijma Delivery Expectancy Questionnaire	measured at 30-32 weeks of gestation	Fear of childbirth (FOC) measured with Wijma Delivery Expectancy Questionnaire (W-DEQ-A) (min 0, max 165; higher scores mean worse outcome)
Labor pain Visual Analogue Scale	measured at birth and at 5 weeks postpartum	Visual Analogue Scale (VAS) for labor pain (min 0, max 10; higher scores mean worse outcome)
Generalized Anxiety Disorder	measured at baseline, at 35-37 weeks of gestation, and at 5 weeks postpartum	Generalized Anxiety Disorder 7-item (GAD-7) (min 0, max 21; higher scores mean worse outcome)

Trial Locations

Locations (1)

Aalto University; 🇫🇮 Espoo, Finland