Effectiveness of an Individual Midwife-Led Psychoeducational Intervention in Reducing Pregnancy-Related Anxiety in Pregnant Women
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pregnancy-Related Anxiety Level
概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Pregnant women with high PrA levels receiving midwife-led individual psychoeducational intervention
干预措施: A Midwife-Led Psychoeducational Intervention to Reduce Pregnancy-Related Anxiety in Low-Risk Pregnant Women (Other)
Standard prenatal care without additional psychoeducational intervention
结局指标
主要结局
Pregnancy-Related Anxiety Level
时间窗: 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.
次要结局
未报告次要终点