- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07660471
Mindfulness-Based Intervention in Primiparous Pregnant Women (MBCP)
Effect of a Mindfulness-Based Intervention on Childbirth Self-Efficacy, Fear of Childbirth, and Self-Compassion in Primiparous Pregnant Women: A Randomized Controlled Trial
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Ebru Solmaz, PhD
- Telefonnummer: +905377737260
- E-mail: esolmaz@agri.edu.tr
Studiesteder
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Ağrı, Tyrkiet (Türkiye)
- Healthy Life Center Pregnancy School
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Kontakt:
- Ebru Solmaz, PhD
- Telefonnummer: +905377737260
- E-mail: esolmaz@agri.edu.tr
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Mindfulness-Based Intervention Group
Participants in this group will receive a four-week mindfulness-based intervention consisting of eight sessions focused on breathing awareness, body awareness, emotional awareness, self-compassion, and mindfulness-based coping strategies for childbirth preparation.
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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.
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Ingen indgriben: Routine Antenatal Care Group
Participants will receive routine antenatal education and standard prenatal care.
No mindfulness-based intervention will be administered.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Childbirth Self-Efficacy
Tidsramme: Baseline and 4 weeks after intervention
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Assessment of childbirth self-efficacy using the Childbirth Self-Efficacy Scale.
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Baseline and 4 weeks after intervention
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Fear of Childbirth
Tidsramme: Baseline and 4 weeks after intervention
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Assessment of fear of childbirth using the Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ-A).
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Baseline and 4 weeks after intervention
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Self-Compassion
Tidsramme: Baseline and 4 weeks after intervention
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Assessment of self-compassion using the Self-Compassion Scale.
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Baseline and 4 weeks after intervention
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- PMI-2026-01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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King's College Hospital NHS TrustEuropean Association for the Study of the LiverRekrutteringCirrhose, lever | HELLP syndrom | Intrahepatisk kolestase af graviditet | Graviditetssygdom | AFLP - Acute Fatty Lever of PregnancyDet Forenede Kongerige
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