Daring Birth - Digital Coaching Solution to Improve Childbirth Experience

NCT06585839 | Completed

• 1 other identifier: 6349/2023
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Childbirth experience Visual Analogue Scale

  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

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

  measured at 3 weeks postpartum

Secondary Outcomes (5)

• Fear of childbirth Visual Analogue Scale

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

• Edinburgh Postnatal Depression Scale

  measured at 5 weeks postpartum

• Wijma Delivery Expectancy Questionnaire

  measured at 30-32 weeks of gestation

• Labor pain Visual Analogue Scale

  measured at birth and at 5 weeks postpartum

• Generalized Anxiety Disorder

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

Study Arms (2)

Study

EXPERIMENTAL

Participants have full access to the investigational device, the Natal Mind mobile application.

Behavioral: Digital coaching solution to improve childbirth experience

Control

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Natal Mind

Study

Application for the control group OTHER

Application for the control group including surveys.

Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Referral to a fetal medicine unit Diagnosed psychotic or bipolar disorders Active substance abuse Participation in another clinical study focusing on perinatal mental health

Sponsors & Collaborators

• Aalto University: lead
• Helsinki University Central Hospital: collaborator
• Business Finland: collaborator

Study Sites (1)

Aalto University

Espoo, Finland

Location

Related Links

• Related Info

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: September 19, 2024
• Study Start: February 16, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 31, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)