Pregnancy-Related Anxiety (PrA)NCT07323459
A Midwife-Led Psychoeducational Intervention to Reduce Pregnancy-Related Anxiety in Low-Risk Pregnant Women
A study testing A Midwife-Led Psychoeducational Intervention to Reduce Pregnancy-Related Anxiety in Low-Risk Pregnant Women in people with Pregnancy-Related Anxiety (PrA) and Fear of Childbirth, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
The goal of this clinical trial is to evaluate whether an individualized psychoeducational intervention led by an experienced midwife can reduce pregnancy-related anxiety (PrA) in pregnant women during the second and third trimesters. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy-Related Anxiety (PrA), Fear of Childbirth
- What is being tested?
- A Midwife-Led Psychoeducational Intervention to Reduce Pregnancy-Related Anxiety in Low-Risk Pregnant Women
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2026to 28 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women in the second or third trimester of pregnancy
- Elevated level of pregnancy-related anxiety (PrA)
- Low obstetric risk pregnant women (no significant medical contraindications to vaginal delivery)
- Consent to participate in individual psychoeducational sessions
- Ability to communicate in Polish at a level sufficient to understand the materials and participate in the sessions
Who cannot join
- Pregnant women with severe mental disorders requiring urgent psychiatric intervention
- Women with serious obstetric complications in the current pregnancy requiring intensive medical monitoring (e.g., severe hypertension, imminent preterm delivery requiring hospitalization)
- Patients already undergoing intensive psychotherapy or pharmacotherapy for anxiety
- Lack of consent to participate or inability to attend sessions (e.g., due to logistical reasons)
- Pregnant women whose pregnancy-related anxiety is not the primary concern, with other dominant anxiety disorders (e.g., GAD unrelated to pregnancy) or other priority health needs
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site
Division of Obstetric and Gynaecological Nursing, Faculty of Health Sciences with the Institute of Maritime and Tropical Medicine, Medical University of Gdańsk
Gdansk, 80-210
About this study
Official title: Effectiveness of an Individual Midwife-Led Psychoeducational Intervention in Reducing Pregnancy-Related Anxiety in Pregnant Women
The goal of this clinical trial is to evaluate whether an individualized psychoeducational intervention led by an experienced midwife can reduce pregnancy-related anxiety (PrA) in pregnant women during the second and third trimesters. The main questions it aims to answer are:
- Can individualized midwife-led psychoeducation significantly reduce pregnancy-related anxiety levels as measured by the PRAQ-R2 questionnaire?
- Does this intervention improve women's sense of control, competence, and readiness for childbirth?
- Can the intervention reduce preferences for cesarean section without medical indication among low-risk pregnant women?
Read more
Participants will:
- Attend 4-6 individual sessions (approximately 60 minutes each) with a midwife, scheduled every 1-2 weeks
- Complete the Pregnancy-Related Anxiety Questionnaire (PRAQ-R2) at the beginning and end of the intervention to measure anxiety levels
- Receive evidence-based education about the physiological process of childbirth, pain management methods (both pharmacological and non-pharmacological), and medical procedures
- Learn and practice stress-reduction techniques including breathing exercises, relaxation methods, and mindfulness
- Develop an individualized birth plan and practice communication skills for effective interaction with medical personnel
- Work on cognitive strategies to address negative thoughts and build positive affirmations about childbirth
- Being tested
- A Midwife-Led Psychoeducational Intervention to Reduce Pregnancy-Related Anxiety in Low-Risk Pregnant Women
- Keywords
- prenatal care, pregnancy-related anxiety, maternal mental health, anxiety, pregnancy
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Midwife-Led Psychoeducational Intervention to Reduce Pregnancy-Related Anxiety in Low-Risk Pregnant WomenOther
Individual program by midwife in 2nd/3rd trimester: 4-6 sessions (~60min), every 1-2 weeks.
Session 1: PRAQ-R2 assessment, identifying fears, building trust. Session 2: Labor stages education, myth verification, visual aids. For multiparous: previous birth discussion.
Session 3: Pain management - breathing, relaxation, massage, hydrotherapy, epidural, nitrous oxide. Practical exercises.
Session 4: Birth plan development, assertive communication training, role-playing.
Session 5: Mindfulness, cognitive restructuring, affirmations, visualization, final PRAQ-R2.
Session 6 (optional): Techniques review, birth plan finalization, Q\&A, contact plan.
Materials: brochures, diagrams, videos, templates, audio instructions. Flexible, individualized.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women with high PrA levels receiving midwife-led individual psychoeducational intervention | Experimental | Not described Receives: Other: A Midwife-Led Psychoeducational Intervention to Reduce Pregnancy-Related Anxiety in Low-Risk Pregnant Women |
| Standard prenatal care without additional psychoeducational intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy-Related Anxiety Level
Measure: Change in Pregnancy-Related Anxiety Questionnaire-Revised 2 (PRAQ-R2) total score from baseline to post-intervention.
Description: The PRAQ-R2 is a validated 10-item questionnaire assessing pregnancy-specific anxiety, using a 5-point Likert scale. Total scores range from 10 to 50, with higher scores indicating higher levels of pregnancy-related anxiety (worse outcome). The Polish validated version of the questionnaire will be used. A decrease in score reflects a reduction in anxiety.
Measured: Baseline (Session 1, before intervention start) and post-intervention (after completing 4-6 sessions, approximately 8-12 weeks from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy-Related Anxiety (PrA)Studies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323459
- Sponsor's protocol ID
- KB/367/2025
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared to protect participant confidentiality and due to data protection regulations. Results will be published in aggregated form.
Publications
Krawczyk A, Czerwinska-Osipiak A, Wojcicka L, Michalik A, Gruszecka A. Study protocol for a midwife-led psychoeducational intervention to reduce pregnancy-related anxiety in low-risk pregnant women. Front Public Health. 2026 Jun 3;14:1832201. doi: 10.3389/fpubh.2026.1832201. eCollection 2026.
PubMed 42317977
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Individual Midwife-Led Psychoeducational Intervention in Reducing Pregnancy-Related Anxiety in Pregnant Women
- ClinicalTrials.gov ID
- NCT07323459
- Acronym / sponsor ID
- KB/367/2025
- Keywords
- prenatal care, pregnancy-related anxiety, maternal mental health, anxiety, pregnancy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 7 Jan 2026 (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 goal of this clinical trial is to evaluate whether an individualized psychoeducational intervention led by an experienced midwife can reduce pregnancy-related anxiety (PrA) in pregnant women during the second and third trimesters. The main questions it aims to answer are:
- Can individualized midwife-led psychoeducation significantly reduce pregnancy-related anxiety levels as measured by the PRAQ-R2 questionnaire?
- Does this intervention improve women's sense of control, competence, and readiness for childbirth?
- Can the intervention reduce preferences for cesarean section without medical indication among low-risk pregnant women?
Participants will:
- Attend 4-6 individual sessions (approximately 60 minutes each) with a midwife, scheduled every 1-2 weeks
- Complete the Pregnancy-Related Anxiety Questionnaire (PRAQ-R2) at the beginning and end of the intervention to measure anxiety levels
- Receive evidence-based education about the physiological process of childbirth, pain management methods (both pharmacological and non-pharmacological), and medical procedures
- Learn and practice stress-reduction techniques including breathing exercises, relaxation methods, and mindfulness
- Develop an individualized birth plan and practice communication skills for effective interaction with medical personnel
- Work on cognitive strategies to address negative thoughts and build positive affirmations about childbirth
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant women with high PrA levels receiving midwife-led individual psychoeducational intervention | Experimental | Other: A Midwife-Led Psychoeducational Intervention to Reduce Pregnancy-Related Anxiety in Low-Risk Pregnant Women |
| Standard prenatal care without additional psychoeducational intervention | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pregnant women in the second or third trimester of pregnancy
- Elevated level of pregnancy-related anxiety (PrA)
- Low obstetric risk pregnant women (no significant medical contraindications to vaginal delivery)
- Consent to participate in individual psychoeducational sessions
- Ability to communicate in Polish at a level sufficient to understand the materials and participate in the sessions
Key exclusion criteria (5 listed)
- Pregnant women with severe mental disorders requiring urgent psychiatric intervention
- Women with serious obstetric complications in the current pregnancy requiring intensive medical monitoring (e.g., severe hypertension, imminent preterm delivery requiring hospitalization)
- Patients already undergoing intensive psychotherapy or pharmacotherapy for anxiety
- Lack of consent to participate or inability to attend sessions (e.g., due to logistical reasons)
- Pregnant women whose pregnancy-related anxiety is not the primary concern, with other dominant anxiety disorders (e.g., GAD unrelated to pregnancy) or other priority health needs
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 |
|---|---|---|
| A Midwife-Led Psychoeducational Intervention to Reduce Pregnancy-Related Anxiety in Low-Risk Pregnant WomenIndividual program by midwife in 2nd/3rd trimester: 4-6 sessions (~60min), every 1-2 weeks. Session 1: PRAQ-R2 assessment, identifying fears, building trust. Session 2: Labor stages education, myth verification, visual aids. For multiparous: previous birth discussion. Session 3: Pain management - breathing, relaxation, massage, hydrotherapy, epidural, nitrous oxide. Practical exercises. Session 4: Birth plan development, assertive communication training, role-playing. Session 5: Mindfulness, cognitive restructuring, affirmations, visualization, final PRAQ-R2. Session 6 (optional): Techniques review, birth plan finalization, Q\&A, contact plan. Materials: brochures, diagrams, videos, templates, audio instructions. Flexible, individualized. | Other | Pregnant women with high PrA levels receiving midwife-led individual psychoeducational intervention |
Primary outcome
Pregnancy-Related Anxiety Level
Time frame: Baseline (Session 1, before intervention start) and post-intervention (after completing 4-6 sessions, approximately 8-12 weeks from baseline)
Measure: Change in Pregnancy-Related Anxiety Questionnaire-Revised 2 (PRAQ-R2) total score from baseline to post-intervention. Description: The PRAQ-R2 is a validated 10-item questionnaire assessing pregnancy-specific anxiety, using a 5-point Likert scale. Total scores range from 10 to 50, with higher scores indicating higher levels of pregnancy-related anxiety (worse outcome). The Polish validated version of the questionnaire will be used. A decrease in score reflects a reduction in anxiety.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Derived from this study: PubMed 42317977Krawczyk A, Czerwinska-Osipiak A, Wojcicka L, Michalik A, Gruszecka A. Study protocol for a midwife-led psychoeducational intervention to reduce pregnancy-related anxiety in low-risk pregnant women. Front Public Health. 2026 Jun 3;14:1832201. doi: 10.3389/fpubh.2026.1832201. eCollection 2026.
- Individual participant dataSharing planned: No. IPD will not be shared to protect participant confidentiality and due to data protection regulations. Results will be published in aggregated form.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A Midwife-Led Psychoeducational Intervention to Reduce Pregnancy-Related Anxiety in Low-Risk Pregnant Women in people with Pregnancy-Related Anxiety (PrA) and Fear of Childbirth, run by Medical University of Gdansk at 1 site in Poland.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 7 Jan 2026. 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 Poland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aleksandra Krawczyk (+48 539 707 706, a.krawczyk@gumed.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy-Related Anxiety Level (time frame: Baseline (Session 1, before intervention start) and post-intervention (after completing 4-6 sessions, approximately 8-12 weeks from baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07323459, which also lists 1 linked publication.
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 7 Jan 2026.