Using Virtual Reality to Reduce Procedural Pain in Children With Cancer
17 de abril de 2020 actualizado por: Jennifer Stinson, The Hospital for Sick Children
Using Virtual Reality to Reduce Procedural Pain in Children With Cancer: A Pilot Randomized Controlled Trial
This study will assess the impact of virtual reality (VR) in decreasing procedural pain related to subcutaneous port (SCP) access in children with cancer.
The study is a pilot-randomized controlled trial (RCT) using a cross-over design that will provide us with detailed information on the feasibility of implementing our trial protocol in a future multi-center RCT as well as preliminary estimate of VR treatment effect on children with cancer undergoing SCP access, including child and parent factors potentially associated with VR distraction treatment efficacy.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The study is a repeated-measures cross-over pilot RCT to examine the feasibility of the trial protocol for a study into the effectiveness of immersive VR in minimizing procedural pain and distress in children with cancer.
The research objectives are to: (1) pilot implementing immersive virtual reality (VR) for effectiveness testing in a future RCT (measured as implementation outcomes); (2) determine treatment effect sizes (measured as preliminary effectiveness outcomes), between VR, programmed to distract children during an SCP needle insertion, and an active control intervention (i.e., watching a video with headphones); and (3) assess impact of child and parent factors potentially associated with VR treatment effectiveness.
Both the intervention and control groups will receive standard medical care (e.g., topical anesthetics).
A convenience sample of 40 children and adolescents with cancer (20 participants per treatment arm; 10 boys and 10 girls per treatment arm) will be recruited.
In addition, each child will act as their own control.
A washout period of 1 month will be used to control for any carry-over effect between conditions.
In addition to usual care, children in the experimental condition will wear the VR headset plus headphones.
In the control condition, children will watch a video (i.e., an age-appropriate video selected by an oncology-affiliated child life specialist) on an iPad, while wearing the same headphones as in the experimental condition.
Implementation outcomes include accrual and retention rates, acceptability and technical difficulties.
Effectiveness outcomes include child pain, distress, and fear, as well as parent distress.
Tipo de estudio
Intervencionista
Inscripción (Actual)
40
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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Ontario
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Toronto, Ontario, Canadá, M5G 1X8
- Hospital for Sick Children
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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
8 años a 18 años (Niño, Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Child and parent able to speak and understand English
- actively undergoing cancer treatment
- being less than 1 year from initial diagnosis
- requiring at least 2 SCP needle insertions for cancer treatment over the following 8 weeks
Exclusion Criteria:
- visual, auditory or cognitive impairments precluding interaction with the intervention or control equipment
- patients with major co-morbid medical or psychiatric conditions (including needle-phobia_ as per their healthcare provider or parent
- end of life patients
- patients with a MRSA infection or symptoms of respiratory or gastrointestinal infection as per any member of their healthcare team which could contaminate the intervention or control equipment
- participation in usability study
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: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Intervention Group
In addition to usual care, the intervention group will receive the Samsung GearVR with head mounted display (HMD), controller, and headphones.
They will situated in front of the nurse and beside/on the lap of the parent, or they may be lying supine.
The VR intervention will use auditory and visual stimuli (simulating the peaceful underwater environment) to distract the child before, during, and after the SCP needle insertion.
Children will be allowed to 'try-out' the VR system before the SCP access to familiarize themselves with the equipment.
The entire study will be videotaped.
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VR with head mounted display (HMD) and headphones.
Treatment
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Comparador activo: Control Group
In addition to usual care, participants in the control group will be seated with their parent and in front of the nurse, according to preference.
Children will watch an age appropriate video selected by an oncology-affiliated child life specialist on an iPad, while wearing the same headphones used in the experimental condition.
The RA will hold the iPad and positioned within a meter of the child so that the child can still see the iPad without the RA interfering in the clinical procedure.
The entire study will be videotaped.
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iPad with headphones. Control
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Accural Rates/Retention Rates
Periodo de tiempo: 6 months
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Using a recruitment log to measure eligible children per recruitment day, reasons for ineligibility, reasons for non-participation and reasons for study attrition.
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6 months
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Acceptability
Periodo de tiempo: 6 months
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Measured using the VR Distraction Satisfaction Questionnaire completed by children and nurses and will collect data on acceptability, perceived utility of pain reducing procedures, and recommendations for changes related to the needle insertion experience.
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6 months
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Outcome measure feasibility
Periodo de tiempo: 6 months
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Will be measured as the percentage of completed outcome measures at baseline and study completion and will be recorded on the VR Distraction Activity Log
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6 months
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Technical Difficulties/Practical Difficulties
Periodo de tiempo: 6 months
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Record data related to technical/practical difficulties associated with the VR intervention, RA observed difficulties in implementing the trial protocol in the clinic and time to complete SCP access.
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6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pain Intensity
Periodo de tiempo: 6 months
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For both pre and post study procedures, children will self report their pain and parents, nurses and the RA will report children's pain using an 11 point NRS scale (0 being no pain at all and 10 being the most pain you can imagine this child or you having)
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6 months
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Child Distress
Periodo de tiempo: 6 months
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For both pre and post study procedures, distress during the SCP study will be measured using the observer-rated Behavioural Approach-Avoidance Scale (BAADS). 2 research team members will code video-recordings from all SCP needle insertion using the BAADS.
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6 months
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Child Fear
Periodo de tiempo: 6 months
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Children will report fear both prior to and following the procedure using the CFS which is a visual scale with established psychometrics in children as young as 5.
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6 months
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Child Pain Catastrophizing
Periodo de tiempo: 6 months
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Children will report baseline tendencies to catastrophize about pain using the PCS-C.
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6 months
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Parent Pain Catastrophizing
Periodo de tiempo: 6 months
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Parents will report baseline tendencies to catastrophize about their child's pain using the PCS-P which is a self-reporting measure of pain.
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6 months
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Parent Distress
Periodo de tiempo: 6 months
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Parents will report on their own level of distress following the child's procedure using the Parent Distress Questionnaire.
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6 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Jennifer Stinson, RN, NP, PhD, The Hospital for Sick Children
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 agosto de 2017
Finalización primaria (Actual)
31 de diciembre de 2019
Finalización del estudio (Actual)
31 de diciembre de 2019
Fechas de registro del estudio
Enviado por primera vez
7 de octubre de 2016
Primero enviado que cumplió con los criterios de control de calidad
7 de octubre de 2016
Publicado por primera vez (Estimar)
11 de octubre de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
20 de abril de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
17 de abril de 2020
Última verificación
1 de abril de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1000053757
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Sí
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
producto fabricado y exportado desde los EE. UU.
No
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