Childbirth ProblemsNCT06585839
Daring Birth - Digital Coaching Solution to Improve Childbirth Experience
A study testing Digital coaching solution to improve childbirth experience in people with Childbirth Problems and Perinatal Depression, run by Aalto University at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Childbirth Problems, Perinatal Depression, Anxiety in Pregnancy
- What is being tested?
- Digital coaching solution to improve childbirth experience
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFinland
- Study dates
- 16 Feb 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Childbirth Problems, Perinatal Depression, Anxiety in Pregnancy, Pregnancy Related, Postpartum Depression, Postpartum Anxiety
- Being tested
- Digital coaching solution to improve childbirth experience, Application for the control group
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital coaching solution to improve childbirth experienceBehavioural
Also called Natal Mind
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.
Application for the control groupOther
Application for the control group including surveys.
| Study group | Role | What they receive |
|---|---|---|
| Study | Experimental | Participants have full access to the investigational device, the Natal Mind mobile application. Receives: Behavioral: Digital coaching solution to improve childbirth experience |
| 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. Receives: Other: Application for the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Childbirth experience Visual Analogue Scale
Visual Analogue Scale (VAS) for childbirth experience (min 0, max 10; higher scores mean better outcome)
Measured: 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: measured at 3 weeks postpartum
Secondary outcomes (5)
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: measured at baseline, at 30-32 weeks of gestation, and at 35-37 weeks of gestation
Edinburgh Postnatal Depression Scale
Postpartum depression measured with Edinburgh Postnatal Depression Scale (EPDS) (min 0, max 30; higher scores mean worse outcome)
Measured: 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: 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: 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: measured at baseline, at 35-37 weeks of gestation, and at 5 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start16 Feb 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childbirth ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalto University
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital, Business Finland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585839
- Sponsor's protocol ID
- 6349/2023
- Status last verified
- Sep 2024
- First submitted
- 16 Aug 2024
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daring Birth - Digital Coaching Solution to Improve Childbirth Experience
- ClinicalTrials.gov ID
- NCT06585839
- Acronym / sponsor ID
- 6349/2023
- Conditions
- Childbirth Problems, Perinatal Depression, Anxiety in Pregnancy, Pregnancy Related, Postpartum Depression, Postpartum Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Aalto UniversityUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital, Business Finland
- Study start
- 16 Feb 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study | Experimental | Behavioral: Digital coaching solution to improve childbirth experienceParticipants have full access to the investigational device, the Natal Mind mobile application. |
| Control | Active comparator | Other: Application for the control groupParticipants use the investigational device solely for inputting data at predetermined points. They receive standard care without the intervention from the investigational device. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Referral to a fetal medicine unit Diagnosed psychotic or bipolar disorders Active substance abuse Participation in another clinical study focusing on perinatal mental health
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital coaching solution to improve childbirth experienceAlso: Natal MindIntervention 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. | Behavioural | Study |
| Application for the control groupApplication for the control group including surveys. | Other | Control |
Primary outcome
Childbirth experience Visual Analogue Scale
Time frame: 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
Time frame: measured at 3 weeks postpartum
Childbirth experience W-DEQ-B (Wijma Delivery Experience Questionnaire) (min 0, max 165; higher scores mean better outcome)
5 secondary outcomes
Fear of childbirth Visual Analogue Scale
Time frame: measured at baseline, at 30-32 weeks of gestation, and at 35-37 weeks of gestation
Edinburgh Postnatal Depression Scale
Time frame: measured at 5 weeks postpartum
Wijma Delivery Expectancy Questionnaire
Time frame: measured at 30-32 weeks of gestation
Labor pain Visual Analogue Scale
Time frame: measured at birth and at 5 weeks postpartum
Generalized Anxiety Disorder
Time frame: measured at baseline, at 35-37 weeks of gestation, and at 5 weeks postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital coaching solution to improve childbirth experience in people with Childbirth Problems and Perinatal Depression, run by Aalto University at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Childbirth experience Visual Analogue Scale (time frame: measured at 3 and 5 weeks postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.