Mindfulness-Based Intervention in Primiparous Pregnant Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mindfulness-Based Intervention.
- Who it may be relevant to
- Registry conditions: Pregnancy, Fear of Childbirth, Childbirth Self-efficacy, Self-Compassion. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of a Mindfulness-Based Intervention on Childbirth Self-Efficacy, Fear of Childbirth, and Self-Compassion in Primiparous Pregnant Women: A Randomized Controlled Trial
Overview
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
- Behavioral Mindfulness-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.
Primary outcome measures
- Childbirth Self-Efficacy [Time frame: Baseline and 4 weeks after intervention]
- Fear of Childbirth [Time frame: Baseline and 4 weeks after intervention]
- Self-Compassion [Time frame: Baseline and 4 weeks after intervention]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Turkey (Türkiye) · 1 center
- Healthy Life Center Pregnancy School — Ağrı
Publications
- Feli R, Heydarpour S, Yazdanbakhsh K, Heydarpour F. The effect of mindfulness-based counselling on the anxiety levels and childbirth satisfaction among primiparous pregnant women: a randomized controlled trial. BMC Psychiatry. 2024 Dec 31;24(1):964. doi: 10.1186/s12888-024-06442-3. PMID 39741245
Identifiers
NCT: NCT07660471 · PMI-2026-01