- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03681743
Virtual Reality vs. Standard-of-Care for Comfort During Minor Plastic Surgery Procedures in Children
A Pragmatic Randomized Controlled Trial of Virtual Reality vs. Standard-of-Care for Comfort During Minor Plastic Surgery Procedures in Children
Children often experience pain and anxiety during minor medical procedures. In addition to pain medication, distraction may help children cope with the pain. This may include interacting with books, TV, toys or videogames.
Virtual Reality (VR) is an immersive experience using sight, sound, and position sense. Using VR may enhance distraction during the painful procedure and may reduce attention to pain.
This study will randomize children (6 - 16 years old) to receive Virtual Reality or standard of care in addition to local anesthetics during minor painful procedure in the Plastic Surgery clinic. Pain, anxiety and satisfaction will be measured as well as the amount of analgesics used and the timing of the procedure. Outcome measures will be compared between the two groups.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ran D Goldman, MD
- Número de teléfono: 7333 604-875-2345
- Correo electrónico: rgoldman@cw.bc.ca
Ubicaciones de estudio
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British Columbia
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Vancouver, British Columbia, Canadá, V6H 3N1
- Reclutamiento
- BC Children's Hospital
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Contacto:
- Ran D Goldman, MD
- Número de teléfono: 7333 604-875-2345
- Correo electrónico: rgoldman@cw.bc.ca
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Sub-Investigador:
- Amir Behboudi, MD
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Sub-Investigador:
- Jugpal S Arneja, MD
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Sub-Investigador:
- Paul GB Clerc, BKin
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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:
- Children age 6 to < 17 years
- Patients scheduled for minor elective plastic surgery procedure
- Parents will sign a consent form and children will sign an assent form
Exclusion Criteria:
- Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay)
- Facial features or injury prohibiting wearing the VR goggles
- Procedure in the face, where the VR system may interfere with Plastic Surgeon work
Plan de estudios
¿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 |
---|---|
Experimental: Virtual Reality
Participants are distracted by wearing the virtual reality headset and watching a roller coaster app during an IV start.
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Los participantes usan un casco de realidad virtual que consta de un teléfono ASUS y un casco de realidad virtual VOX+ Z3 3D.
El teléfono ejecuta la aplicación VR Roller Coaster para producir el entorno virtual.
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Sin intervención: Control (Standard-of-Care)
Participants are distracted with Standard-of-Care by doctors and/or parents.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Pain measured using the Faces Pain Scale - Revised.
Periodo de tiempo: Pain is reported by children immediately following completion of the minor plastic surgery procedure
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Level of pain as reported by children using Faces Pain Scale - Revised.
The scale includes six faces that represent progressively more intense features of pain.
Children point to the face that best represents their current level of pain.
The minimum score is 0 (representing least pain) and the maximum score is 10 (representing greater pain).
The scale increase in increments of 2.
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Pain is reported by children immediately following completion of the minor plastic surgery procedure
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Dosis de medicamento
Periodo de tiempo: Estos se registrarán durante el procedimiento e inmediatamente después del procedimiento utilizando la ficha del paciente.
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Cuánto anestésico tópico o local se usa y cuándo se usa (tiempo de 24 horas); cuántos sedantes se usan y cuándo se usan (tiempo de 24 horas); cuántos analgésicos se usan y cuándo se usan (tiempo de 24 horas).
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Estos se registrarán durante el procedimiento e inmediatamente después del procedimiento utilizando la ficha del paciente.
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Anxiety using the Venham Situational Anxiety Score
Periodo de tiempo: Anxiety is reported by children immediately following completion of the minor plastic surgery procedure
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Level of Situational Anxiety as reported by children using the Venham Situational Anxiety Score.
This scale includes 8 sets of 2 images of children which represent differing levels of anxiety.
Children point to the child that best represents them in that instance.
In each set of 2 images of children, one represents greater anxiety (scored as 1) and one represents lesser anxiety (scored as 0).
The points from each set of images are totaled.
The minimum score is 0 (least anxious) and maximum score is 8 (most anxious).
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Anxiety is reported by children immediately following completion of the minor plastic surgery procedure
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Patient Satisfaction determined by Global Rating Scale
Periodo de tiempo: Satisfaction questions are reported by children immediately following completion of the minor plastic surgery procedure
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Satisfaction from the procedure is determined by asking 4 questions on a global rating scale.
This scale goes from 0-10 where 0 represents "not very much" and 10 represents "very much."
Questions are developed from previous virtual reality research.
"Overall, how satisfied are you with pain management during plastic surgery?" "Overall, how satisfied are you with anxiety management during plastic surgery?" "To what extent did you feel like you went into the virtual world?" "How much fun did you have while playing in the virtual world?"
These questions will be analyzed individually not summed.
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Satisfaction questions are reported by children immediately following completion of the minor plastic surgery procedure
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Timing
Periodo de tiempo: Documented immediately after patient and family given discharge instructions
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Time in minutes from readiness for procedure (availability of child, staff and equipment) until completion of procedure (physician does not need to touch the patient anymore) and until discharged from the plastic surgery clinic department (given discharge instructions).
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Documented immediately after patient and family given discharge instructions
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Patient Use of Virtual Reality in the Future by Yes/No Question
Periodo de tiempo: Reported by children immediately following completion of the minor plastic surgery procedure
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Patients were asked if they would use virtual reality in the future for a similar procedure.
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Reported by children immediately following completion of the minor plastic surgery procedure
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ran D Goldman, MD, University of British Columbia
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
- H18-01150
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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