Clinical trial NCT06585839: Daring Birth - Digital Coaching Solution to Improve Childbirth Experience
Official title: Daring Birth - Digital Coaching Solution to Improve Childbirth Experience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childbirth Problems
Perinatal Depression
Anxiety in Pregnancy
Pregnancy Related
Postpartum Depression
Postpartum Anxiety
Fear of Childbirth
Lead sponsor: Aalto University
Sponsor class: OTHER
Collaborators: name: Helsinki University Central Hospital
name: Business Finland
First posted: 2024-09-19
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Childbirth experience Visual Analogue Scale
timeFrame: measured at 3 and 5 weeks postpartum
measure: Wijma Delivery Experience Questionnaire
timeFrame: measured at 3 weeks postpartum
Secondary outcomes:
measure: Fear of childbirth Visual Analogue Scale
timeFrame: measured at baseline, at 30-32 weeks of gestation, and at 35-37 weeks of gestation
measure: Edinburgh Postnatal Depression Scale
timeFrame: measured at 5 weeks postpartum
measure: Wijma Delivery Expectancy Questionnaire
timeFrame: measured at 30-32 weeks of gestation
measure: Labor pain Visual Analogue Scale
timeFrame: measured at birth and at 5 weeks postpartum
measure: Generalized Anxiety Disorder
timeFrame: measured at baseline, at 35-37 weeks of gestation, and at 5 weeks postpartum
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: Aalto University
Study officials:
References: