Skip to main content
OpenTrials
Completed

NCT Number: NCT06585839

Daring Birth - Digital Coaching Solution to Improve Childbirth Experience

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Childbirth Problems Anxiety in Pregnancy Depression, Postpartum Depressive Disorder Fear of Childbirth Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Perinatal Depression Postpartum Anxiety Postpartum Depression Pregnancy Complications Pregnancy Related Puerperal Disorders Urogenital Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aalto University

Espoo, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digital coaching solution to improve childbirth experience

Behavioral

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.

Other names: Natal Mind

Application for the control group

Other

Application for the control group including surveys.

Primary outcomes

  1. Childbirth experience Visual Analogue Scale

    Time frame: measured at 3 and 5 weeks postpartum

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

  2. Wijma Delivery Experience Questionnaire

    Time frame: measured at 3 weeks postpartum

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

Secondary outcomes

  1. Fear of childbirth Visual Analogue Scale

    Time frame: 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)

  2. Edinburgh Postnatal Depression Scale

    Time frame: measured at 5 weeks postpartum

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

  3. Wijma Delivery Expectancy Questionnaire

    Time frame: 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)

  4. Labor pain Visual Analogue Scale

    Time frame: measured at birth and at 5 weeks postpartum

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

  5. Generalized Anxiety Disorder

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Aalto University

Other

Collaborators

  • Business Finland
  • Helsinki University Central Hospital

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.