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A Midwife-Led Psychoeducational Intervention to Reduce Pregnancy-Related Anxiety in Low-Risk Pregnant Women

M

Medical University of Gdansk

Status

Not yet enrolling

Conditions

Pregnancy-Related Anxiety (PrA)
Fear of Childbirth

Treatments

Other: A Midwife-Led Psychoeducational Intervention to Reduce Pregnancy-Related Anxiety in Low-Risk Pregnant Women

Study type

Interventional

Funder types

Other

Identifiers

NCT07323459
KB/367/2025

Details and patient eligibility

About

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

Enrollment

80 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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 design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

Pregnant women with high PrA levels receiving midwife-led individual psychoeducational intervention
Experimental group
Treatment:
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 group

Trial contacts and locations

1

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Central trial contact

Aleksandra Krawczyk

Data sourced from clinicaltrials.gov

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