- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07774936
Fetal Health Locus of Control, Maternal Anxiety, and Cardiotocography in High-Risk Pregnancies
The Relationship Between Fetal Health Locus of Control Perceptions, Anxiety Levels, and Fetal Cardiotocography Parameters in High-Risk Pregnant Women
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Fetal health locus of control reflects pregnant women's beliefs regarding the factors that determine the health of their unborn child. These beliefs may influence health-related behaviors during pregnancy. Maternal anxiety may also affect fetal heart rate regulation through autonomic and neuroendocrine mechanisms.
This study will prospectively evaluate high-risk pregnant women at 32 weeks of gestation or later who are undergoing routine non-stress testing at the Perinatology Outpatient Clinic. After written informed consent is obtained, participants will complete the Fetal Health Locus of Control Scale and the Beck Anxiety Inventory on the same day as their routine 20-minute NST.
The Fetal Health Locus of Control Scale consists of three dimensions: Internal Health Locus of Control, Chance Health Locus of Control, and Powerful Others Health Locus of Control. NST recordings will be evaluated according to FIGO-based criteria by an experienced investigator. Baseline fetal heart rate, accelerations, reactivity, decelerations, and other relevant cardiotocographic parameters will be recorded.
This study aims prospective cross-sectional evaluation of high-risk pregnant women undergoing routine non-stress testing. The primary objective is to investigate the relationships among fetal health locus of control perceptions, maternal anxiety levels, and fetal cardiotocography parameters. Secondary analyses will examine the relationships of these variables with maternal sociodemographic and obstetric characteristics.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Doruk C Katlan
- Numéro de téléphone: +905353475411
- E-mail: dcek2000@yahoo.com
Sauvegarde des contacts de l'étude
- Nom: Nebahat Uzunay
- Numéro de téléphone: +905052609436
- E-mail: nebahatuzunay@gmail.com
Lieux d'étude
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Istanbul, Turquie (Türkiye)
- Recrutement
- Istanbul Training and Research Hospital
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Contact:
- Doruk C Katlan
- Numéro de téléphone: +905353475411
- E-mail: dcek2000@yahoo.com
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Sous-enquêteur:
- Nebahat Uzunay
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Sous-enquêteur:
- Filiz Değirmenci
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Contact:
- Nebahat Uzunay
- Numéro de téléphone: +905052609436
- E-mail: nebahatuzunay@gmail.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Singleton pregnancy at 32 weeks of gestation or later
- Being followed for a high-risk pregnancy
- No known diagnosed psychiatric disorder and no current psychiatric medication use
- Absence of a fetal condition considered likely to affect the NST tracing
- Maternal age between 18 and 45 years
Exclusion Criteria:
- Gestational age below 32 weeks and/or multiple pregnancy
- Presence of a fetal condition considered likely to affect the NST tracing
- Acute maternal infection or an obstetric emergency
- Known diagnosed psychiatric disorder and/or current psychiatric medication use
- Maternal age below 18 years or above 45 years
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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High-Risk Pregnant Women
Pregnant women at 32 weeks of gestation or later who are being followed for a high-risk pregnancy and undergo routine non-stress testing.
Participants will complete the Fetal Health Locus of Control Scale and the Beck Anxiety Inventory on the same day as their routine NST.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Association Between Fetal Health Locus of Control and Maternal Anxiety
Délai: At the single study visit, on the same day as the routine NST
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The relationship between scores obtained from the Fetal Health Locus of Control Scale and maternal anxiety measured using the Beck Anxiety Inventory will be evaluated.
The Internal Health Locus of Control, Chance Health Locus of Control, and Powerful Others Health Locus of Control dimensions will be analyzed separately.
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At the single study visit, on the same day as the routine NST
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Association Between Fetal Health Locus of Control and Cardiotocography Parameters
Délai: During the 20-minute routine NST performed at the single study visit
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Associations between fetal health locus of control dimensions and NST parameters, including baseline fetal heart rate, number of accelerations, reactivity, and presence of decelerations, will be evaluated.
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During the 20-minute routine NST performed at the single study visit
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Association Between Maternal Anxiety and Cardiotocography Parameters
Délai: During the 20-minute routine NST performed at the single study visit
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The relationship between maternal anxiety measured using the Beck Anxiety Inventory and NST parameters, including baseline fetal heart rate, number of accelerations, reactivity, and presence of decelerations, will be evaluated.
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During the 20-minute routine NST performed at the single study visit
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Associations With Sociodemographic and Obstetric Characteristics
Délai: At the single study visit
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Associations of fetal health locus of control, maternal anxiety levels, and cardiotocography parameters with maternal sociodemographic and obstetric characteristics, including age, gravidity, education level, income level, consanguinity, smoking status, and pre-pregnancy preparation, will be evaluated.
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At the single study visit
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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
Autres numéros d'identification d'étude
- ISTANBUL TRH - 14.04.2026-121
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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