Anxiety in Pregnancy, Childbirth Problems, Fear of Childbirth, Perinatal Depression, Postpartum Anxiety, Postpartum Depression, Pregnancy Related
Conditions
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.
Interventions
BEHAVIORALDigital 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.
OTHERApplication for the control group
Application for the control group including surveys.
Sponsors
Helsinki University Central Hospital
Business Finland
Aalto University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Childbirth experience Visual Analogue Scale | measured at 3 and 5 weeks postpartum | Visual Analogue Scale (VAS) for childbirth experience (min 0, max 10; higher scores mean better outcome) |
| Wijma Delivery Experience Questionnaire | measured at 3 weeks postpartum | Childbirth experience W-DEQ-B (Wijma Delivery Experience Questionnaire) (min 0, max 165; higher scores mean better outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wijma Delivery Expectancy Questionnaire | 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) |
| Fear of childbirth Visual Analogue Scale | 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) |
| Generalized Anxiety Disorder | 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) |
| Labor pain Visual Analogue Scale | measured at birth and at 5 weeks postpartum | Visual Analogue Scale (VAS) for labor pain (min 0, max 10; higher scores mean worse outcome) |
| Edinburgh Postnatal Depression Scale | measured at 5 weeks postpartum | Postpartum depression measured with Edinburgh Postnatal Depression Scale (EPDS) (min 0, max 30; higher scores mean worse outcome) |
Countries
Finland
Outcome results
None listed