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Mindfulness-Based Intervention in Primiparous Pregnant Women

Effect of a Mindfulness-Based Intervention on Childbirth Self-Efficacy, Fear of Childbirth, and Self-Compassion in Primiparous Pregnant Women: A Randomized Controlled Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07660471
Acronym
MBCP
Enrollment
128
Registered
2026-06-22
Start date
2026-06-01
Completion date
2026-10-31
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childbirth Self-efficacy, Fear of Childbirth, Pregnancy, Self-Compassion

Keywords

Mindfulness, Mindfulness-Based Intervention, Pregnancy, Primiparous Pregnant Women, Fear of Childbirth, Childbirth Self-Efficacy, Self-Compassion, Maternal Mental Health, Randomized Controlled Trial

Brief summary

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.

Detailed description

Pregnancy is a period characterized by significant physical, psychological, and social changes. Fear of childbirth, low childbirth self-efficacy, and difficulties in self-compassion may negatively affect maternal well-being and childbirth experiences. Mindfulness-based interventions have been increasingly used to support psychological health during pregnancy; however, evidence regarding their effects on childbirth self-efficacy, fear of childbirth, and self-compassion remains limited. This study is designed as a randomized controlled trial to evaluate the effectiveness of a mindfulness-based intervention among primiparous pregnant women attending a pregnancy school affiliated with a Healthy Life Center in Ağrı, Türkiye. A total of 128 eligible pregnant women will be randomly assigned to either an intervention group or a control group. Participants in the intervention group will receive a four-week mindfulness-based intervention consisting of eight sessions focused on breathing awareness, body awareness, emotional awareness, non-judgmental acceptance, self-compassion, and mindfulness-based coping strategies for childbirth preparation. Participants in the control group will continue to receive routine antenatal education and standard prenatal care. Data will be collected before and after the intervention using validated instruments assessing childbirth self-efficacy, fear of childbirth, and self-compassion. The results of this study may provide evidence for the integration of mindfulness-based approaches into antenatal care programs to enhance maternal psychological well-being and preparedness for childbirth.

Interventions

BEHAVIORALMindfulness-Based Intervention

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.

Sponsors

Agri Ibrahim Cecen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Masking description

This is an open-label study. Participants and investigators are aware of group assignments.

Intervention model description

Participants will be randomly assigned to one of two parallel groups. The intervention group will receive a four-week mindfulness-based intervention consisting of eight sessions, while the control group will continue to receive routine antenatal education and standard prenatal care. Outcome measures will be assessed at baseline and after completion of the intervention.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Pregnant women aged 18 years and older * Primiparous women * Singleton pregnancy * Gestational age between 28 and 32 weeks * No known obstetric complications * Ability to read and understand Turkish * Attendance at the Pregnancy School of the Healthy Life Center * Willingness to participate and provide written informed consent * Willingness to participate in the mindfulness-based intervention program

Exclusion criteria

* 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 * Previous participation in a structured mindfulness, meditation, or similar awareness-based program * Inability to attend intervention sessions regularly

Design outcomes

Primary

MeasureTime frameDescription
Childbirth Self-EfficacyBaseline and 4 weeks after interventionAssessment of childbirth self-efficacy using the Childbirth Self-Efficacy Scale.
Fear of ChildbirthBaseline and 4 weeks after interventionAssessment of fear of childbirth using the Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ-A).
Self-CompassionBaseline and 4 weeks after interventionAssessment of self-compassion using the Self-Compassion Scale.

Countries

Turkey (Türkiye)

Contacts

CONTACTEbru Solmaz, PhD
esolmaz@agri.edu.tr+905377737260

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 23, 2026