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| Name | Class |
|---|---|
| Helsinki University Central Hospital | OTHER |
| Business Finland | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study | Experimental | Participants have full access to the investigational device, the Natal Mind mobile application. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Fear of childbirth Visual Analogue Scale | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalto University | Espoo | Finland |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Application for the control group | Other | Application for the control group including surveys. |
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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 | 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 | 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 | 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 |
| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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