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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Sevim Şenol Karataş, MD
- Número de teléfono: +905325736611
- Correo electrónico: drsevimkaratas@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Sait F Öner, MD
- Número de teléfono: +90 533 627 13 58
- Correo electrónico: sfatihoner@gmail.com
Ubicaciones de estudio
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Elâzığ
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Elâzığ, Elâzığ, Turquía (Türkiye), 23100
- Elazığ Fethi Sekin City Hospital
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Investigador principal:
- Sevim Şenol Karataş, MD
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Contacto:
- Sevim Şenol Karataş, MD
- Número de teléfono: +90 532 573 6611
- Correo electrónico: drsevimkaratas@gmail.com
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Contacto:
- Sait F Öner, MD
- Número de teléfono: +90 533 627 13 58
- Correo electrónico: sfatihoner@gmail.com
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Sub-Investigador:
- Sait F Öner, MD
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Sub-Investigador:
- Cengiz Şanlı, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Video-Based Education
Participants receive standardized video-based preoperative education before elective cesarean delivery.
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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.
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Comparador activo: 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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in STAI-S Score
Periodo de tiempo: Before education and immediately after education on the day of surgery
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Change in State-Trait Anxiety Inventory-State (STAI-S) score from before to after preoperative education.
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Before education and immediately after education on the day of surgery
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Change in Serum Cortisol Level
Periodo de tiempo: Before education and immediately after education on the day of surgery
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Change in serum cortisol concentration from before to after preoperative education.
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Before education and immediately after education on the day of surgery
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sevim Şenol Karataş, Elazıg Fethi Sekin Sehir Hastanesi
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- QR Code-Cesarean
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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