Daring Birth - Digital Coaching Solution to Improve Childbirth Experience

Aalto University

Status: Completed

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

Treatments: Behavioral: Digital coaching solution to improve childbirth experience; Other: Application for the control group

Study type: Interventional

Funder types: Other

Identifiers

NCT06585839

6349/2023

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Study

Experimental group

Description:

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

Treatment:

Behavioral: Digital coaching solution to improve childbirth experience

Control

Active Comparator group

Description:

Participants use the investigational device solely for inputting data at predetermined points. They receive standard care without the intervention from the investigational device.

Treatment:

Other: Application for the control group