- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: sibel akgül kartal
- Numéro de téléphone: 05012405539
- E-mail: sibelakgulkartal@yyu.edu.tr
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Fear of Childbirth
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Childbirth Self-Efficacy
Délai: 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 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
Délai: Baseline, immediately after the intervention, and 4 weeks after the intervention (36-37 weeks' gestation)
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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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 251899
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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