- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07692724
Effect of Theory-Based Childbirth Preparation Education in Nulliparous Pregnant Women (HBM-SE Birth)
Effect of a Health Belief Model-and Self-Efficacy Theory-Based Childbirth Preparation Education on Fear of Childbirth, Childbirth Self-Efficacy, and Preferred Mode of Delivery in Nulliparous Pregnant Women: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effect of a Health Belief Model- and Self-Efficacy Theory-based childbirth preparation education on fear of childbirth, childbirth self-efficacy, birth preferences, and childbirth preparation behaviors among nulliparous pregnant women.
Eligible nulliparous pregnant women between 28 and 32 weeks of gestation will be randomly assigned to either an intervention group or a control group. The intervention group will receive a structured childbirth preparation education program consisting of four sessions in addition to routine antenatal care, while the control group will receive routine antenatal care only. Data will be collected before the intervention, immediately after the intervention, during follow-up in late pregnancy, and after childbirth. The findings of this study may contribute to improving childbirth-related outcomes by reducing fear of childbirth and enhancing self-efficacy and preparedness for birth.
Studieoversikt
Status
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: sibel akgül kartal
- Telefonnummer: 05012405539
- E-post: sibelakgulkartal@yyu.edu.tr
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
Female Aged 18 years or older Nulliparous pregnancy Between 28 and 32 weeks of gestation Able to communicate in Turkish Willing to participate in the study and provide informed consent
Exclusion Criteria:
High-risk pregnancy Diagnosis or treatment of a psychiatric disorder Any condition that may interfere with communication or participation in the educational sessions
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: arm1
Participants in this group will receive a structured childbirth preparation education program based on the Health Belief Model and Self-Efficacy Theory in addition to routine antenatal care.
The program consists of four educational sessions focusing on fear of childbirth, benefits of vaginal birth, coping skills during labor, and childbirth preparation planning.
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A four-session structured educational program designed to reduce fear of childbirth and improve childbirth self-efficacy, birth preferences, and childbirth preparation behaviors among nulliparous pregnant women.
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Aktiv komparator: arm2
Participants in this group will receive routine antenatal care and standard pregnancy education services provided by the health institution without the structured study intervention.
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Participants will receive routine antenatal care and standard pregnancy education services provided by the health institution.
No structured childbirth preparation education based on the Health Belief Model or Self-Efficacy Theory will be provided.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Fear of Childbirth
Tidsramme: Baseline (28-32 weeks' gestation), immediately after completion of the intervention, and 4 weeks after the intervention (36-37 weeks' gestation).
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Fear of childbirth will be assessed using the Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ A).
Higher scores indicate higher levels of fear of childbirth.
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Baseline (28-32 weeks' gestation), immediately after completion of the intervention, and 4 weeks after the intervention (36-37 weeks' gestation).
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Childbirth Self-Efficacy
Tidsramme: Baseline (28-32 weeks' gestation), immediately after completion of the intervention, and 4 weeks after the intervention (36-37 weeks' gestation).
|
Childbirth self-efficacy will be assessed using the Childbirth Self-Efficacy Inventory Short Form (CBSEI-C32).
Higher scores indicate higher levels of childbirth self-efficacy.
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Baseline (28-32 weeks' gestation), immediately after completion of the intervention, and 4 weeks after the intervention (36-37 weeks' gestation).
|
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Birth Preference
Tidsramme: Baseline, immediately after the intervention, and 4 weeks after the intervention (36-37 weeks' gestation)
|
Birth preference will be assessed using the Pregnant Women's Preferences for Mode of Delivery Questionnaire.
Higher scores indicate a stronger preference for vaginal birth.
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Baseline, immediately after the intervention, and 4 weeks after the intervention (36-37 weeks' gestation)
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Childbirth Preparation Behaviors
Tidsramme: Baseline (28-32 weeks' gestation), immediately after completion of the intervention, and 4 weeks after the intervention (36-37 weeks' gestation).
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Childbirth preparation behaviors will be assessed using the Childbirth Preparation Behavior Form developed by the researchers.
The questionnaire evaluates the extent to which pregnant women engage in behaviors to prepare for childbirth.
Higher scores indicate better childbirth preparation behaviors.
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Baseline (28-32 weeks' gestation), immediately after completion of the intervention, and 4 weeks after the intervention (36-37 weeks' gestation).
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Actual Mode of Delivery
Tidsramme: At the time of childbirth.
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Actual mode of delivery will be recorded using the Birth Record Form and categorized as vaginal birth or cesarean birth.
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At the time of childbirth.
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 251899
Plan for individuelle deltakerdata (IPD)
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