- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07736664
Effects of Different Transport Methods on Preoperative Anxiety and Fear in Preschool Children
Visão geral do estudo
Status
Descrição detalhada
Preoperative anxiety is frequently observed in preschool children undergoing surgical procedures. The unfamiliar hospital environment, separation from parents, and fear of anesthesia and surgery may increase children's anxiety and fear before surgery. Elevated preoperative anxiety has been associated with poor cooperation during anesthesia induction, increased postoperative pain, maladaptive behavioral changes, and delayed recovery.
Several non-pharmacological interventions have been developed to reduce children's anxiety before surgery. Among these, distraction techniques and child-friendly environmental modifications have shown promising results. Transporting children to the operating room using battery-powered ride-on cars has recently emerged as an innovative distraction strategy that may transform the transport process into a playful experience.
This controlled study aims to compare three different operating room transport methods in preschool children undergoing elective day surgery: routine transport by walking with a parent, transport by stretcher, and transport using a battery-powered ride-on car. Preoperative anxiety and fear will be assessed using validated pediatric assessment tools before surgery. The study findings may provide evidence for the effectiveness of child-friendly transport methods in reducing preoperative anxiety and fear and support the implementation of non-pharmacological interventions in pediatric surgical care.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: İlayda Tekelioğlu
- Número de telefone: +905512559774
- E-mail: ilaydatekelioglu@gmail.com
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Children aged 3-6 years (36-72 months)
- Scheduled to undergo elective surgery in the Department of Pediatric Surgery
- Able to communicate appropriately for their age
- Have sufficient cognitive development to respond to the study assessment scales
- Child and parent/legal guardian are able to speak and understand Turkish
- Written informed consent obtained from the child's legal guardian (and child assent obtained when appropriate)
Exclusion Criteria:
- Presence of visual, hearing, or communication impairments that could interfere with study participation
- Receipt of premedication requiring sedation due to an emergency condition
- Presence of severe pain that could affect anxiety assessment before surgery
- Inability to safely use the battery-powered ride-on car because of physical or mobility limitations before surgery
- Withdrawal of consent by the child's legal guardian or the child's unwillingness to continue participation
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Routine Walking with Parent
Participants are transported to the operating room by walking with a parent according to the hospital's routine practice.
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Participants are transported to the operating room by walking with a parent according to the hospital's routine practice.
|
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Experimental: Stretcher Transport
Participants are transported to the operating room using a stretcher.
|
Participants are transported to the operating room using a stretcher.
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Experimental: Battery-Powered Ride-on Car Transport
Participants are transported to the operating room using an age-appropriate battery-powered ride-on car accompanied by the researcher.
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Participants are transported to the operating room using an age-appropriate battery-powered ride-on car accompanied by the researcher.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Preoperative Anxiety Level
Prazo: Immediately before transfer to the operating room (preoperative period).
|
Preoperative anxiety levels will be assessed using the Children's Anxiety Scale-State (CAS-S), a visual thermometer-like scale with scores ranging from 0 to 10. Higher scores indicate higher levels of state anxiety.
Scores will be compared among preschool children transported to the operating room by walking with a parent, stretcher, or battery-powered ride-on car.
|
Immediately before transfer to the operating room (preoperative period).
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Preoperative Fear Level
Prazo: Immediately before transfer to the operating room (preoperative period)
|
Preoperative fear levels will be assessed using the Children's Fear Scale (CFS), which consists of five facial expressions and is scored from 0 to 4. A score of 0 indicates no fear, while a score of 4 indicates severe fear.
Higher scores indicate higher levels of fear.
Scores will be compared among preschool children transported to the operating room by walking with a parent, stretcher, or battery-powered ride-on car.
|
Immediately before transfer to the operating room (preoperative period)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Nurdan Akçay Didişen, PhD, Ege university
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
Outros números de identificação do estudo
- 30333
Plano para dados de participantes individuais (IPD)
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