Mindfulness-Based Intervention in Primiparous Pregnant Women

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAgri Ibrahim Cecen University

About this trial

This randomized controlled trial aims to evaluate the effect of a mindfulness-based intervention on childbirth self-efficacy, fear of childbirth, and self-compassion among primiparous pregnant women. Eligible pregnant women will be randomly assigned to either a mindfulness intervention group or a control group receiving routine antenatal education and standard prenatal care. The intervention program will consist of eight sessions delivered over four weeks. Outcomes will be assessed before and after the intervention using validated measurement tools. The findings may contribute to the development of effective psychosocial interventions to improve maternal well-being during pregnancy.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Pregnant women aged 18 years and older

Primiparous women

Singleton pregnancy

Gestational age between 28 and 32 weeks

Disqualifiers

Multiple pregnancy

High-risk obstetric complications (e.g., preeclampsia, gestational diabetes, placenta previa)

Diagnosed severe psychiatric disorders (e.g., psychotic disorders, bipolar disorder)

Substance or alcohol dependence

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mindfulness-Based Intervention

    Behavioral

    A four-week mindfulness-based intervention consisting of eight sessions delivered twice weekly. The program includes breathing awareness, body awareness, emotional awareness, non-judgmental acceptance, self-compassion practices, and mindfulness-based coping strategies for childbirth preparation. Sessions will be delivered face-to-face and will last approximately 60-90 minutes each.

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: Mindfulness-Based Intervention GroupExperimental treatment 1 intervention
Group B: Routine Antenatal Care GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Childbirth Self-Efficacy

Assessment of childbirth self-efficacy using the Childbirth Self-Efficacy Scale.

Time frame
Baseline and 4 weeks after intervention
2

Fear of Childbirth

Assessment of fear of childbirth using the Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ-A).

Time frame
Baseline and 4 weeks after intervention
3

Self-Compassion

Assessment of self-compassion using the Self-Compassion Scale.

Time frame
Baseline and 4 weeks after intervention

Secondary outcomes

Other outcomes

Sponsors and contacts

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