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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Sevim Şenol Karataş, MD
- Número de telefone: +905325736611
- E-mail: drsevimkaratas@gmail.com
Estude backup de contato
- Nome: Sait F Öner, MD
- Número de telefone: +90 533 627 13 58
- E-mail: sfatihoner@gmail.com
Locais de estudo
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Elâzığ
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Elâzığ, Elâzığ, Turquia (Türkiye), 23100
- Elazığ Fethi Sekin City Hospital
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Investigador principal:
- Sevim Şenol Karataş, MD
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Contato:
- Sevim Şenol Karataş, MD
- Número de telefone: +90 532 573 6611
- E-mail: drsevimkaratas@gmail.com
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Contato:
- Sait F Öner, MD
- Número de telefone: +90 533 627 13 58
- E-mail: sfatihoner@gmail.com
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Subinvestigador:
- Sait F Öner, MD
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Subinvestigador:
- Cengiz Şanlı, MD
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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 Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in STAI-S Score
Prazo: 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
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- QR Code-Cesarean
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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Ensaios clínicos em Video-Based Preoperative Education
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Selcuk UniversityRecrutamento