Effects of Different Transport Methods on Preoperative Anxiety and Fear in Preschool Children
Descripción general del estudio
Estado
Descripción detallada
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 estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: İlayda Tekelioğlu
- Número de teléfono: +905512559774
- Correo electrónico: ilaydatekelioglu@gmail.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: 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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Preoperative Anxiety Level
Periodo de tiempo: Immediately before transfer to the operating room (preoperative period).
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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.
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Immediately before transfer to the operating room (preoperative period).
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Preoperative Fear Level
Periodo de tiempo: 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
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
Otros números de identificación del estudio
- 30333
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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