Distraction and Nitrous Oxide for Venous Puncture (DISPO)
Comparison in Anxiety and Pain Scores Between Distraction and Nitrous Oxide for Procedural Pain in Children Aged 3 to 9 Years : a Randomized Clinical Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The study is aiming at demonstrating the efficacy of active distraction by an iPad on the anxiety consequent to venipuncture and insertion of a peripheral vein catheter. The comparator is nitrous oxide in a 50% mixture with oxygen that is routinely used for sedation during procedural pain. However, nitrous oxide has secondary effects particularly on the inhibition of Vitamin B12.
The primary outcome is anxiety scores. Secondary outcomes are pain scores and satisfaction of parents and health providers.
All children will have EMLA cream (mixture prilocaine and lidocaine) applied one hour prior to venous punction. Anxiety, pain and satisfaction scores will be recorded at baseline and then within an hour following the venipuncture and insertion of the peripheral vein catheter.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Geneva, Suiza, 1206
- Geneva Children's Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Venous track needed
- French mother tongue
- Age between 3 and 9 years old
Exclusion Criteria:
- Children with cognitive disorder (autism, metabolic disorders,
- Children with cerebral-motor disability
- Children who don't speak french
- Children with ADHD treatment
- Children with epilepsy
- Children who present contraindication to the use of Nitrous oxide
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: iPad distraction
Children of this group will receive the iPad when the nurse will prepare the material for the venous track. They will choose a game adapted to their age and will be able to play it during all the procedure time. Intervention : game on iPad |
Many games will be programmed on the iPad and organized by age.
The child will choose one game and play it during all the procedure time.
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Comparador activo: Nitrous Oxide
Children of this group will receive the Nitrous Oxide 3 minutes before the intervention (venous track). They will keep the mask during all the procedure time. Intervention : Nitrous Oxide |
Nitrous oxide will be provided to the child by a mask 3 minutes before the intervention and during all this one.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Anxiety score
Periodo de tiempo: From one hour prior to venous puncture until 1 hour afterwards
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Anxiety level measured by a scale (modified Yale Preoperative Anxiety Scale) measured at baseline, during the venous puncture and one hour afterwards.
The scale scores from a minimum of 5 (no anxiety) to 22 (extremely anxious).
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From one hour prior to venous puncture until 1 hour afterwards
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pain score
Periodo de tiempo: From one hour prior to venous puncture until 1 hour afterwards
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Pain intensity level will be measured at baseline, during the venous puncture and one hour afterwards, by a scale (Visual analog scale), which includes a score of 0 (no Pain) to 10 (worse pain).
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From one hour prior to venous puncture until 1 hour afterwards
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Satisfaction score
Periodo de tiempo: From time of venous puncture until 1 hour afterwards
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Satisfaction of parents and care givers about the cares given to the child using a rating scale from 1(not satisfied at all) to 10 (extremely satisfied).
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From time of venous puncture until 1 hour afterwards
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Manon Cadoux, Student, University of Geneva
- Investigador principal: Virginie Luscher, Student, University of Geneva
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
- in progress (Kaul Pediatric Research Institute of the Alabama Children's Hospital Foundation)
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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