Daring Birth - Digital Coaching Solution to Improve Childbirth Experience

January 30, 2025 updated by: Aalto University

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Espoo, Finland
        • Aalto University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study
Participants have full access to the investigational device, the Natal Mind mobile application.
Behavioral: Digital coaching solution to improve childbirth experience
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
Active Comparator: Control
Participants use the investigational device solely for inputting data at predetermined points. They receive standard care without the intervention from the investigational device.
Other: Application for the control group
Application for the control group including surveys.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
measured at 3 and 5 weeks postpartum
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)
measured at 3 weeks postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
measured at baseline, at 30-32 weeks of gestation, and at 35-37 weeks of gestation
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)
measured at 5 weeks postpartum
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)
measured at 30-32 weeks of gestation
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)
measured at birth and at 5 weeks postpartum
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)
measured at baseline, at 35-37 weeks of gestation, and at 5 weeks postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aalto University

Collaborators

Helsinki University Central Hospital
Business Finland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2024

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

August 16, 2024

First Submitted That Met QC Criteria

September 3, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 30, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6349/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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