Video Versus Verbal Preoperative Education in Elective Cesarean Delivery (VIDEO-CS)
Effects of Verbal and Video-Based Preoperative Education on Anxiety and Serum Cortisol Response in Women Scheduled for Elective Cesarean Delivery: A Prospective Randomized Controlled Trial
This prospective randomized controlled trial aims to evaluate the effects of verbal and video-based preoperative education on anxiety levels and serum cortisol response in women scheduled for elective cesarean delivery under spinal anesthesia.
Eligible participants will be randomly assigned to receive either standard verbal education or a standardized video-based educational intervention before surgery. Anxiety levels will be assessed using the State-Trait Anxiety Inventory (STAI-S), and serum cortisol levels will be measured before and after the educational intervention.
The primary objective is to compare the effectiveness of the two educational methods in reducing preoperative anxiety and physiological stress response.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Preoperative anxiety is common among women undergoing elective cesarean delivery and may contribute to increased physiological stress responses, including elevated serum cortisol levels. Effective preoperative education may improve patient understanding of the surgical and anesthetic process and reduce anxiety.
This single-center prospective randomized controlled trial will be conducted at Elazig Fethi Sekin City Hospital. Women aged 18 years or older who are scheduled for elective cesarean delivery under spinal anesthesia and provide written informed consent will be eligible for participation.
Participants will be randomly allocated to one of two groups:
Verbal Education Group:
Participants will receive routine face-to-face verbal information regarding the surgical procedure and spinal anesthesia from an anesthesiologist.
- Video-Based Education Group:
Participants will watch a standardized educational video covering the same information provided in the verbal education group.
Educational interventions will be delivered at least one hour before surgery.
Anxiety levels will be assessed using the State-Trait Anxiety Inventory-State (STAI-S) before and after the educational intervention. Serum cortisol concentrations will be measured from venous blood samples obtained during routine clinical blood collection before and after education.
The primary outcomes are changes in STAI-S scores and serum cortisol levels following the educational intervention. Secondary analyses will evaluate the relationship between educational modality and physiological stress response.
A total of 140 participants are planned for enrollment, with 70 participants in each study group.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Elâzığ
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Elâzığ, Elâzığ, Turquie (Türkiye), 23100
- Elazığ Fethi Sekin City Hospital
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Female participants aged 18 years or older
- Scheduled for elective cesarean delivery
- Planned to undergo spinal anesthesia
- American Society of Anesthesiologists (ASA) physical status I or II
- Able to understand the study procedures and provide written informed consent
Exclusion Criteria:
- Emergency cesarean delivery
- History of psychiatric disease
- Current use of anxiolytic or antidepressant medications
- Endocrine disorders, including adrenal or thyroid disease
- Current corticosteroid therapy
- Previous surgery performed under spinal anesthesia
- Cognitive impairment or communication difficulties that may interfere with completion of anxiety assessments
- ASA physical status III, IV, or V
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Video-Based Education
Participants receive standardized video-based preoperative education before elective cesarean delivery.
|
Participants will watch a standardized preoperative educational video providing information about cesarean delivery, spinal anesthesia, the perioperative process, potential risks and complications, postoperative expectations, and recovery.
The video is designed to improve patient understanding and reduce preoperative anxiety.
|
|
Comparateur actif: Verbal Education
Participants receive standard verbal preoperative education before elective cesarean delivery.
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Participants will receive standard face-to-face verbal preoperative education from an anesthesiologist regarding cesarean delivery, spinal anesthesia, the perioperative process, potential risks and complications, postoperative expectations, and recovery.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in State-Trait Anxiety Inventory-State (STAI-S) Score
Délai: Before education and immediately after education on the day of surgery
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Change in STAI-S score from before to after preoperative education.
The STAI-S consists of 20 items with total scores ranging from 20 to 80. Higher scores indicate greater anxiety.
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Before education and immediately after education on the day of surgery
|
|
Change in Serum Cortisol Level
Délai: Before education and immediately after education on the day of surgery
|
Change in serum cortisol concentration (µg/dL) from before to after preoperative education.
Higher serum cortisol levels indicate greater physiological stress response.
|
Before education and immediately after education on the day of surgery
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Sevim Şenol Karataş, Elazıg Fethi Sekin Sehir Hastanesi
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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
- QR Code-Cesarean
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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