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Virtual Reality for Anxiolysis During Laceration Repair in the Pediatric Emergency Room

1 de diciembre de 2019 actualizado por: Daniel Marc Fein, Montefiore Medical Center

A Feasibility Study for the Use of Virtual Reality to Reduce Procedural Anxiety for Children Undergoing Laceration Repair in the Pediatric Emergency Room

The investigators propose a pilot study to examine the feasibility of utilizing immersive virtual reality to reduce procedural anxiety in children undergoing non-facial laceration repair in the Pediatric Emergency Department.

The investigators hypothesize that virtual reality will be well-received by patients and their caregivers, and that the anxiety provoked by laceration repair will be mitigated by the immersive virtual reality experience.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

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

  • Estados Unidos
    • New York
      • Bronx, New York, Estados Unidos, 10467
        • Children's Hospital at Montefiore

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

5 años a 13 años (Niño)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • children 5-13 years of age
  • present to ED during the study period with non-facial lacerations
  • patient to undergo wound closure with sutures

Exclusion Criteria:

  • Patients with lacerations on the head/face
  • Patients with lacerations sustained in conjunction with loss of consciousness, altered mental status, life-threatening injuries/illness or multi-trauma
  • Patients who sustained a laceration in conjunction with an open fracture
  • Patients with open skin, lice, scabies, or other infectious skin conditions on the head/face
  • Patients with a history of or current symptoms of vertigo
  • Patients who are blind
  • Patients with significant developmental or cognitive delays who may not be able to engage with or tolerate the virtual reality environment, as determined by their parent/caregiver
  • Patients on whom the VR headset does not fit appropriately
  • Non-English speaking patients will be excluded from this study (we do not have funds available to translate the study documents into other languages)

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: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Virtualy Reality App
Virtual reality app produced by KindVR played via a stereoscopic head mounted display (Samsung GearVR) and headphones that the patient will wear over their eyes and ears.
Otro: Virtual Reality App
Virtual reality app produced by KindVR played via a stereoscopic head mounted display (Samsung GearVR) and headphones that the patient will wear over their eyes and ears.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The percentage of children whose anxiety score did NOT increase by ≥ 20mm on a visual analog anxiety scale
Periodo de tiempo: from the time of enrollment to the placement of the first stitch, which is typically ranges from 15 to 90 minutes
Anxiety score will be measured on a Visual Analog Scale. This scale consists of a 100mm line on which parents mark their estimate of their child's anxiety level, with anxiety level increasing from left (0mm) to right (100mm).
from the time of enrollment to the placement of the first stitch, which is typically ranges from 15 to 90 minutes

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in anxiety score
Periodo de tiempo: from the time of enrollment to wound irrigation, which typically ranges from 5 to 80 minutes
Anxiety score will be measured on a Visual Analog Scale. This scale consists of a 100mm line on which parents mark their estimate of their child's anxiety level, with anxiety level increasing from left (0mm) to right (100mm).
from the time of enrollment to wound irrigation, which typically ranges from 5 to 80 minutes
Change in anxiety score
Periodo de tiempo: from enrollment to local/regional anesthesia, which typically ranges from 15 to 100 minutes
Anxiety score will be measured on a Visual Analog Scale. This scale consists of a 100mm line on which parents mark their estimate of their child's anxiety level, with anxiety level increasing from left (0mm) to right (100mm).
from enrollment to local/regional anesthesia, which typically ranges from 15 to 100 minutes
Change in anxiety score
Periodo de tiempo: from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Anxiety score will be measured on a Visual Analog Scale. This scale consists of a 100mm line on which parents mark their estimate of their child's anxiety level, with anxiety level increasing from left (0mm) to right (100mm).
from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Patient satisfaction with the use of VR during the procedure as assessed by a patient questionnaire
Periodo de tiempo: Patients will fill out the questionnaire at the time their sutured laceration repair is completed, which is typically between 20 and 180 minutes after enrollment

To assess the receptiveness of patients to this technology as well as the efficacy of the VR experience, participants will be asked to complete a brief questionnaire at the end of the procedure assessing their experience while using VR during the laceration repair.

These surveys address the patient's comfort and satisfaction with the technology. We have created separate patient surveys for children ages 5-7 and children ages 8-13 - these surveys have the same questions, but the answer choices are simplified from Likert Rating Scales (scale of 1 - 5) for the older children to a simple "Yes, No, I don't know" choice for the younger children. There is also a free text response question for which patients can provide additional comments or suggestions regarding their use of VR during laceration repair.
Patients will fill out the questionnaire at the time their sutured laceration repair is completed, which is typically between 20 and 180 minutes after enrollment
Parent/guardian satisfaction with the use of VR during the procedure as assessed by a parent/guardian questionnaire
Periodo de tiempo: Parent/guardian will fill out the questionnaire at the time their child's sutured laceration repair is completed, which is typically between 20 and 180 minutes after enrollment
To assess the receptiveness of patients to this technology as well as the efficacy of the VR experience, parents/guardians will be asked to complete a brief survey at the end of the procedure assessing their comfort and satisfaction with their child's use of VR during the laceration repair. The survey contains both rating questions with Likert Rating Scales (scale of 1 - 5), yes/no questions, and questions with free text responses.
Parent/guardian will fill out the questionnaire at the time their child's sutured laceration repair is completed, which is typically between 20 and 180 minutes after enrollment
Provider satisfaction with the use of VR during the procedure as measured by a provider questionnaire
Periodo de tiempo: Providers will fill out the questionnaire at the time their patient's sutured laceration repair is completed, which is typically between 20 and 180 minutes after enrollment
The ED provider who performed the laceration repair will complete a survey at the end of the procedure assessing their satisfaction with using VR during laceration repair. The survey contains yes/no questions, multiple choice questions, and questions with free text responses.
Providers will fill out the questionnaire at the time their patient's sutured laceration repair is completed, which is typically between 20 and 180 minutes after enrollment
Need for adjunctive anxiolysis methods, sedation, or restraints during the procedure as reported on a provider questionnaire
Periodo de tiempo: from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
The ED provider who performed the laceration repair will complete a questionnaire at the end of the procedure which will detail which, if any, adjunctive measures were needed during the procedure.
from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Headache due to VR use as reported on a qualitative simulator sickness questionnaire
Periodo de tiempo: from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
The patient (with the help of their parent/guardian for younger children) will complete a questionnaire assessing for symptoms of simulator sickness, including nausea, headache, dizziness, and eye pain. The questionnaire uses Likert Scales (ranging from 1 to 5, with 5 indicating a higher level of symptom) to assess nausea, headache, dizziness, and eye pain associated with VR use.
from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Eye pain due to VR use as reported on a qualitative simulator sickness questionnaire
Periodo de tiempo: from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
The patient (with the help of their parent/guardian for younger children) will complete a questionnaire assessing for symptoms of simulator sickness, including nausea, headache, dizziness, and eye pain. The questionnaire uses Likert Scales (ranging from 1 to 5, with 5 indicating a higher level of symptom) to assess nausea, headache, dizziness, and eye pain associated with VR use.
from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Nausea due to VR use as reported on a qualitative simulator sickness questionnaire
Periodo de tiempo: from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
The patient (with the help of their parent/guardian for younger children) will complete a questionnaire assessing for symptoms of simulator sickness, including nausea, headache, dizziness, and eye pain. The questionnaire uses Likert Scales (ranging from 1 to 5, with 5 indicating a higher level of symptom) to assess nausea, headache, dizziness, and eye pain associated with VR use.
from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Dizziness due to VR use as reported on a qualitative simulator sickness questionnaire
Periodo de tiempo: from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
The patient (with the help of their parent/guardian for younger children) will complete a questionnaire assessing for symptoms of simulator sickness, including nausea, headache, dizziness, and eye pain. The questionnaire uses Likert Scales (ranging from 1 to 5, with 5 indicating a higher level of symptom) to assess nausea, headache, dizziness, and eye pain associated with VR use.
from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
Barriers to the use of VR identified during this study as reported on a provider questionnaire
Periodo de tiempo: from enrollment to procedure completion, which typically ranges from 20 to 180 minutes
The ED provider who performed the laceration repair will complete a questionnaire at the end of the procedure which will detail which, if any, barriers to the use of VR that they encountered during the procedure
from enrollment to procedure completion, which typically ranges from 20 to 180 minutes

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Montefiore Medical Center

Colaboradores

KindVR

Investigadores

  • Investigador principal: Daniel M Fein, MD, Montefiore Medical Center

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)

15 de abril de 2018

Finalización primaria (Actual)

22 de noviembre de 2019

Finalización del estudio (Actual)

22 de noviembre de 2019

Fechas de registro del estudio

Enviado por primera vez

10 de marzo de 2018

Primero enviado que cumplió con los criterios de control de calidad

16 de marzo de 2018

Publicado por primera vez (Actual)

23 de marzo de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de diciembre de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

1 de diciembre de 2019

Última verificación

1 de diciembre de 2019

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2017-8466

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

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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