Daring Birth - Digital Coaching Solution to Improve Childbirth Experience

Aalto University200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

200

Conditions

Childbirth Problems Perinatal Depression Anxiety in Pregnancy

Interventions

Digital coaching solution to improve childbirth experienceBEHAVIORAL

Intervention provides coaching to improve the childbirth experience and offers comprehensive perinatal mental health support to pregnant and postpartum women. It features emotion tracking and exercise customization functionality, along with an avatar-based platform. The app includes digital psychotherapy exercises and psychoeducation. These core elements are complemented by exercises in mindfulness, relaxation, and self-soothing.

Application for the control groupOTHER

Application for the control group including surveys.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Childbirth experience Visual Analogue Scale

Visual Analogue Scale (VAS) for childbirth experience (min 0, max 10; higher scores mean better outcome)

Time frame: measured at 3 and 5 weeks postpartum

Wijma Delivery Experience Questionnaire

Childbirth experience W-DEQ-B (Wijma Delivery Experience Questionnaire) (min 0, max 165; higher scores mean better outcome)

Time frame: measured at 3 weeks postpartum

Secondary Outcomes

Fear of childbirth Visual Analogue Scale

Visual Analogue Scale (VAS) for fear of childbirth (FOC) (min 0, max 10; higher scores mean worse outcome)

Time frame: measured at baseline, at 30-32 weeks of gestation, and at 35-37 weeks of gestation

Edinburgh Postnatal Depression Scale

Postpartum depression measured with Edinburgh Postnatal Depression Scale (EPDS) (min 0, max 30; higher scores mean worse outcome)

Time frame: measured at 5 weeks postpartum

Wijma Delivery Expectancy Questionnaire

Fear of childbirth (FOC) measured with Wijma Delivery Expectancy Questionnaire (W-DEQ-A) (min 0, max 165; higher scores mean worse outcome)

Time frame: measured at 30-32 weeks of gestation

Labor pain Visual Analogue Scale

Visual Analogue Scale (VAS) for labor pain (min 0, max 10; higher scores mean worse outcome)

Time frame: measured at birth and at 5 weeks postpartum

Generalized Anxiety Disorder

Generalized Anxiety Disorder 7-item (GAD-7) (min 0, max 21; higher scores mean worse outcome)

Time frame: measured at baseline, at 35-37 weeks of gestation, and at 5 weeks postpartum