The Effect of Using a Kaleidoscope During Central Venous Catheter Dressing Changes in Children With Cancer
9 de diciembre de 2021 actualizado por: Pınar BEKAR, Mehmet Akif Ersoy University
The Effect of Using a Kaleidoscope During Central Venous Catheter Dressing Changes on Anxiety and Pain in Children With Cancer: A Randomised Controlled Study
Many medical interventions, including the dressing of central venous catheters, a common procedure used for children with cancer, cause anxiety and pain in children.
This can adversely affect their care and recovery.
This study aims to determine the effect of using a kaleidoscope during central venous catheter dressing on anxiety and pain in children with cancer.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
This was a randomised controlled trial with 60 children aged 6-12 diagnosed with cancer who were placed either in a kaleidoscope group (n=30) or a control group (n=30). Each child's anxiety was evaluated by the child using the Child Fear Scale before, during and after a central venous catheter dressing procedure, and each child's pain during and after the procedure was evaluated by the child using the Wong-Baker Faces Pain Rating Scale (WB-FACES). Each child's heart rate and oxygen saturation were measured with a pulse oximeter device before, during and after central venous catheter dressing.
The children in kaleidoscope group looked into the kaleidoscope and slowly turned it. This distraction procedure began immediately before the central venous catheter dressing and continued until it was finished.
No intervention was performed to reduce pain and anxiety for children in the control group.
Parents accompanied their children during the procedure in both groups.
Tipo de estudio
Intervencionista
Inscripción (Actual)
60
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
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Burdur, Pavo
- Pınar BEKAR
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
6 años a 12 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- a cancer diagnosis,
- having a central venous catheter,
- 6-12 years old,
- not having taken any analgesics in the 6 hours before the central venous catheter dressing, -being in a non-terminal phase of the disease,
- absence of neutropenia,
- volunteering to participate in the study,
- the absence of any health problems that prevent communication in the parent or the child.
Exclusion Criteria:
-the reporting of pain for another reason at the time of the central venous catheter dressing.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿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 |
|---|---|
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Experimental: Kaleidoscope Group
Children in this group were told what a kaleidoscope is and how to use it before their central venous catheter dressing.
The children were then asked if they would like to look into the kaleidoscope.
The children looked into the kaleidoscope and slowly turned it.
The researcher asked the children about the colours and shapes seen inside the kaleidoscope.
This distraction procedure began immediately before the central venous catheter dressing and continued until it was finished.
The kaleidoscope was disinfected before each use.
A kaleidoscope was provided for all children in this group by the same researcher.
Parents accompanied their children during the catheter dressing.
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The children looked into the kaleidoscope and slowly turned it.
The researcher asked the children about the colours and shapes seen inside the kaleidoscope.
This distraction procedure began immediately before the central venous catheter dressing and continued until it was finished.
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Sin intervención: Control Group
No intervention was performed to reduce pain and anxiety for children in the control group.
Parents accompanied their children during the procedure.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Wong-Baker FACES Pain Rating Scale (WB-FACES)
Periodo de tiempo: 5 MONTHS
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The Wong-Baker Faces Pain Rating Scale (WB-FACES) is used to evaluate pain levels in children.
This numeric rating scale ranges from 0 to 10 and is represented by faces that display emotions ranging from smiling (0 = very happy or no pain) to crying (10 = the worst pain).
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5 MONTHS
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Children's Fear Scale (CFS)
Periodo de tiempo: 5 MONTHS
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The Children's Fear Scale (CFS) is used to evaluate anxiety levels in children.
It consists of five facial expressions representing a range from no anxiety (0) to severe anxiety (4).
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5 MONTHS
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Heart Rate
Periodo de tiempo: 5 MONTHS
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The heart rate and oxygen saturation values of the children in both groups were measured and recorded by the researcher 3 minutes before the procedure, during the procedure and 5 minutes after the procedure using a pulse oximeter device.
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5 MONTHS
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Oxygen Saturation
Periodo de tiempo: 5 MONTHS
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The heart rate and oxygen saturation values of the children in both groups were measured and recorded by the researcher 3 minutes before the procedure, during the procedure and 5 minutes after the procedure using a pulse oximeter device.
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5 MONTHS
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Emine EFE, Prof.Dr., Akdeniz University, Department of Child Health and Disease Nursing
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de enero de 2021
Finalización primaria (Actual)
31 de mayo de 2021
Finalización del estudio (Actual)
31 de mayo de 2021
Fechas de registro del estudio
Enviado por primera vez
7 de junio de 2021
Primero enviado que cumplió con los criterios de control de calidad
7 de junio de 2021
Publicado por primera vez (Actual)
11 de junio de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de diciembre de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
9 de diciembre de 2021
Última verificación
1 de junio de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KAEK-791
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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