- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07820904
THE EFFECT OF 360° VIDEO-ASSISTED TRAINING ON VERTICAL BIRTH POSITIONS IN PRIMIPAROUS WOMEN ON FEAR OF CHILDBIRTH, SELF-EFFICACY IN CHILDBIRTH, SATISFACTION WITH CHILDBIRTH, AND PERINEAL TRAUMA: A RANDOMIZED CONTROLLED TRIAL
This randomized controlled trial aims to evaluate the effects of 360-degree video-supported upright birth position education on fear of childbirth, childbirth self-efficacy, birth satisfaction, and perineal trauma among primiparous pregnant women. Eligible participants will be randomly assigned to one of three intervention groups or a control group. In addition to routine antenatal care, participants in the intervention groups will receive 360-degree video-supported education on one of three upright birth positions: use of a Pilates ball, birth dance, or squatting. Participants in the control group will receive routine antenatal care only.
The study will examine whether 360-degree video-supported education can help primiparous women prepare for childbirth, reduce fear of childbirth, improve childbirth self-efficacy and birth satisfaction, and reduce the occurrence of perineal trauma. The outcomes of the three intervention groups will also be explored to determine whether the effects differ according to the type of upright birth position.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Rozerin Balcı
- Numéro de téléphone: +905398339950
- E-mail: rbalci@beu.edu.tr
Lieux d'étude
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Bitlis
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Bitlis, Bitlis, Turquie (Türkiye)
- Bitlis State Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Having signed the Informed Consent Form.
- Being able to speak and understand Turkish.
- Being literate.
- Having no impairment that would interfere with auditory, visual, or cognitive communication.
- Being primiparous.
- Having a singleton live fetus.
- Being between 28 and 32 weeks of gestation.
- Having a fetus in cephalic presentation.
- Planning a vaginal birth.
- Being enrolled and randomized before the onset of labor.
- Being able to use a smartphone or tablet.
- Having sufficient physical and cognitive ability to watch the 360° video education.
- Having moderate fear of childbirth, defined as a score of 38 or higher on the W-DEQ-A.
Exclusion Criteria:
- Refusal to participate in the study or withdrawal from the study.
- Development of a serious maternal or fetal complication during labor that prevents continuation of the study intervention.
- Giving birth by elective or emergency cesarean section.
- Loss of study data during the research process.
- Giving birth outside Bitlis State Hospital.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Pilates Ball Group
Participants will receive 360° video-supported education on upright birth positions using a Pilates ball.
|
Participants will receive standardized 360° video-supported education on upright birth positions.
The education will include Pilates ball exercises, birth dance, and supported squatting techniques.
Each video will demonstrate the relevant birth position and provide information on its proper use, body movements, weight transfer, and position changes.
Each video will be approximately 12 minutes (±30 seconds) in duration and will be viewed using a smartphone or tablet.
|
|
Expérimental: Birth Dance Group
Participants will receive 360° video-supported education on upright birth positions using birth dance.
|
Participants will receive standardized 360° video-supported education on upright birth positions.
The education will include Pilates ball exercises, birth dance, and supported squatting techniques.
Each video will demonstrate the relevant birth position and provide information on its proper use, body movements, weight transfer, and position changes.
Each video will be approximately 12 minutes (±30 seconds) in duration and will be viewed using a smartphone or tablet.
|
|
Expérimental: Squatting Group
Participants will receive 360° video-supported education on upright birth positions using supported squatting.
|
Participants will receive standardized 360° video-supported education on upright birth positions.
The education will include Pilates ball exercises, birth dance, and supported squatting techniques.
Each video will demonstrate the relevant birth position and provide information on its proper use, body movements, weight transfer, and position changes.
Each video will be approximately 12 minutes (±30 seconds) in duration and will be viewed using a smartphone or tablet.
|
|
Aucune intervention: Control Group
Participants will receive routine antenatal care without the 360° video-supported upright birth positions education during the study period.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Childbirth Fear Score
Délai: From baseline (before randomization) to 24-48 hours after childbirth
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Childbirth fear will be assessed using the Wijma Delivery Expectancy/Experience Questionnaire-A (W-DEQ-A) before randomization and the W-DEQ-B after childbirth.
The change in childbirth fear score will be compared between the study groups.
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From baseline (before randomization) to 24-48 hours after childbirth
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Childbirth Self-Efficacy Score
Délai: From baseline (before randomization) to 24-48 hours after childbirth
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Childbirth self-efficacy will be assessed using the Childbirth Self-Efficacy Scale before randomization and within 24-48 hours after childbirth.
The change in score will be compared between the study groups.
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From baseline (before randomization) to 24-48 hours after childbirth
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Birth Satisfaction Score
Délai: Within 24-48 hours after childbirth
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Birth satisfaction will be assessed using the Birth Satisfaction Scale Short Form within 24-48 hours after childbirth.
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Within 24-48 hours after childbirth
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Perineal Trauma
Délai: Immediately after childbirth
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Perineal trauma will be assessed immediately after childbirth during routine clinical evaluation and classified according to the Sultan classification as intact perineum, episiotomy, or first-, second-, third-, or fourth-degree perineal laceration.
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Immediately after 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
Autres numéros d'identification d'étude
- BEU-MIDWIFERY-VIRTUAL-BIRTH-20
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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