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Effects of an 8-week birth preparation intervention on women's mental well-being

Comparing the MyDoula app intervention with standard care for pregnant women regarding mental wellbeing: Randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16756340
Enrollment
170
Registered
2023-03-08
Start date
2021-09-08
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fear of childbirth

Interventions

The intervention group undergoes an eight-week psychological birth preparation program, which is provided via an online application with the name MyDoula. The program contains daily morning mindfulnes

Sponsors

Fachhochschule Potsdam
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Pregnant women between the 20.1 and 27.0 week of pregnancy

Exclusion criteria

Exclusion criteria: 1. Aged 17 years old and younger 2. German is not at a native language level 3. Taking psychotropic drugs, having a psychological diagnosis or being counselled by a psychologist, psychotherapist or psychiatrist at the time of the study 4. Pregnant women that give birth before finalizing the 8 weeks-MyDoula-App-Program (e.g. due to premature birth) 5. When people didn’t agree to be informed about incidental findings, e.g. high scores in the Edinburgh Postnatal Depression Scale (EPDS) screening

Design outcomes

Primary

MeasureTime frame
1. Negative birth expectations measured using the Wijma Delivery Expectations (W-DEQ) questionnaire at baseline and after 8 weeks 2. Support within the relationship measured using the “Relationship Assessment Scale” questionnaire at baseline 3. Depression Scores are measured using the “Edinburgh Depression Scale” questionnaire at baseline and 8 weeks later 4. Support within relationships measured using the “Social support instrument” questionnaire at baseline 5. Mother-Child-Bonding measured using the “Maternal antenatal attachment scale” questionnaire at baseline and 8 weeks later 6. Mental Wellbeing measured using the “Mental Wellbeing Scale” questionnaire at baseline and 8 weeks later 7. Mindfulness measured using the “Frankfurter Fragebogen Achtsamkeit (FFA)” questionnaire at baseline and 8 weeks later 8. Birth mindset measured using the “Mindset and Birth” questionnaire at baseline

Secondary

MeasureTime frame
1. Dyadic coping mechanisms of participants measured using two items of the dyadic coping inventory (DCI) at baseline 2. Quality of current relationship measured using the relationship assessment scale (RAS) at baseline 3. Social support measured using the social support instrument (ESSI) at baseline 4. Prenatal mother-child bonding measured using the Maternal antenatal attachment scale (MAAS) at baseline and 8 weeks after baseline 5. Mental wellbeing measured using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) at baseline and 8 weeks after baseline 6. Mindfulness measured using the Frankfurter Fragebogen Achtsamkeit (FFA) at baseline and 8 weeks after baseline 7. Birthyear, sex, gender, German spoken and understood as native language, graduation, professional qualification, employment, professional position, management position, salary, number of persons in household, persons under 14 in household, marital status, taking psychotropic drugs (exclusion criteria), having psychotherapy (exclusion criteria), having a psychological diagnosis (exclusion criteria), having biological children, type of previous birth(s), type of previous negative birth experiences, abortion, miscarriage, pregnancy week, single/multiple pregnancy, planned pregnancy, worries about high/size of baby, complications during pregnancy, diseases regarding the unborn child, medical risk during pregnancy, worries/fears, main care person, satisfaction with pregnancy care, planned caesarian section (CS) and reasons, trauma, carrying out mindfulness exercises regularly, regular use of other pregnancy apps, using a birth preparation course, use of health apps, using online/offline offers regarding mental health, using online/offline offers regarding mindfulness measured using a Likert scale questionnaire at baseline 8. Pregnancy week, worries about high/size of the unborn baby, complications during pregnancy, diseases regarding the unborn child, medical risk during pregnancy, worries/fears, and pl

Countries

Austria, Germany, Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026