Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Adult Patients for Pain Control During Spinal Injections (SI) (VR adult)
12 de enero de 2021 actualizado por: Sayed Wahezi, Albert Einstein College of Medicine
A three-group parallel randomized controlled trial to evaluate the efficacy of virtual reality analgesia (VRA) to decrease patient procedural pain and anxiety in the Adult patients undergoing Spinal Injections (SI).
Descripción general del estudio
Estado
Retirado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Fase
- Fase 2
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
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Adult requiring Spinal Injections
- Adult > 18years
- Adults with intact vision who can attend VR intervention
Exclusion Criteria:
- Anyone < 18 years
- Adults who are not attentive to VR secondary to poor concentration, poor cognition to external stimuli
- Adults who request moderate IV sedation
- Adults with photic-induced seizures
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: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: Spinal Injection
Adults receiving Spinal Injection(SI) without Virtual Reality(VR).
|
All groups will receive pharmaceutical analgesia, either lidocaine or bupivacaine, depending on the condition.
Dosage and frequency of pharmaceutical analgesia will be tailored to each participant's condition.
All groups will receive pharmaceutical analgesia, either lidocaine or bupivacaine, depending on the condition.
Dosage and frequency of pharmaceutical analgesia will be tailored to each participant's condition.
|
|
Comparador activo: Google Cardboard
Adults receiving SI while using Google Cardboard Virtual reality head mounted display powered by a iPod touch
|
All groups will receive pharmaceutical analgesia, either lidocaine or bupivacaine, depending on the condition.
Dosage and frequency of pharmaceutical analgesia will be tailored to each participant's condition.
All groups will receive pharmaceutical analgesia, either lidocaine or bupivacaine, depending on the condition.
Dosage and frequency of pharmaceutical analgesia will be tailored to each participant's condition.
Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Adult Patients for Pain Control During Spinal Injections (SI).
VRA is a the oculus or the google cardboard that helps decrease anxiety.
The participant in the oculus or the Google cardboard arms are asked to watch VR videos during the spinal injection.
|
|
Comparador activo: Oculus
Adults receiving SI while using VR with Oculus Rift.
|
All groups will receive pharmaceutical analgesia, either lidocaine or bupivacaine, depending on the condition.
Dosage and frequency of pharmaceutical analgesia will be tailored to each participant's condition.
All groups will receive pharmaceutical analgesia, either lidocaine or bupivacaine, depending on the condition.
Dosage and frequency of pharmaceutical analgesia will be tailored to each participant's condition.
Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Adult Patients for Pain Control During Spinal Injections (SI).
VRA is a the oculus or the google cardboard that helps decrease anxiety.
The participant in the oculus or the Google cardboard arms are asked to watch VR videos during the spinal injection.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pain intensity as measured by the Visual Analog Scale
Periodo de tiempo: Immediately after receiving spinal injection
|
Participants are asked to rate their intensity of pain, by completing a Visual Analog Scale (VAS).
The VAS consists of lines and emojis used to indicate pain level; the lines range from 0 (= no pain) to 10 (= unbearable pain) and the emojis range from 0 (= no pain) to 5 (= unbearable pain).
|
Immediately after receiving spinal injection
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Anxiety Level as measured by the Visual Facial Anxiety Scale
Periodo de tiempo: Immediately after receiving spinal injection
|
Participants are asked to rate their anxiety level by completing the Visual Facial Anxiety Scale(VFAS).
The VFAS consists of emojis ranging from 0 (= no anxiety) to 5 (highest anxiety).
|
Immediately after receiving spinal injection
|
|
Heart rate as measured by the Empatica E4 wristband
Periodo de tiempo: Baseline, during and Immediately after the procedure
|
The Empatica E4 wristband is a wearable research device that offers real-time physiological data acquisition and software for in-depth analysis and visualization.
Empatica E4 wristband is worn by the participant throughout the procedure to measure heart rate before, during and after the procedure.
|
Baseline, during and Immediately after the procedure
|
|
Systolic Blood Pressure as measured by the Empatica E4 wristband
Periodo de tiempo: Baseline, during and Immediately after the procedure
|
The Empatica E4 wristband is a wearable research device that offers real-time physiological data acquisition and software for in-depth analysis and visualization.
Empatica E4 wristband is worn by the participant throughout the procedure to measure Blood Pressure before, during and after the procedure.
|
Baseline, during and Immediately after the procedure
|
|
Diastolic Blood Pressure as measured by the Empatica E4 wristband
Periodo de tiempo: Baseline, during and Immediately after the procedure
|
The Empatica E4 wristband is a wearable research device that offers real-time physiological data acquisition and software for in-depth analysis and visualization.
Empatica E4 wristband is worn by the participant throughout the procedure to measure Blood Pressure before, during and after the procedure.
|
Baseline, during and Immediately after the procedure
|
|
Sympathetic skin response as measured by the Empatica E4 wristband
Periodo de tiempo: Baseline, during and Immediately after the procedure
|
The Empatica E4 wristband is a wearable research device that offers real-time physiological data acquisition and software for in-depth analysis and visualization.
Empatica E4 wristband is worn by the participant throughout the procedure to measure Sympathetic skin response before, during and after the procedure.
|
Baseline, during and Immediately after the procedure
|
|
Temperature as measured by the Empatica E4 wristband
Periodo de tiempo: Baseline, during and Immediately after the procedure
|
The Empatica E4 wristband is a wearable research device that offers real-time physiological data acquisition and software for in-depth analysis and visualization.
Empatica E4 wristband is worn by the participant throughout the procedure to measure Temperature before, during and after the procedure.
|
Baseline, during and Immediately after the procedure
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Sayed Wahezi, MD, Albert Einstein College Of Medicine
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 (Anticipado)
30 de noviembre de 2020
Finalización primaria (Anticipado)
1 de diciembre de 2020
Finalización del estudio (Anticipado)
1 de diciembre de 2020
Fechas de registro del estudio
Enviado por primera vez
5 de diciembre de 2018
Primero enviado que cumplió con los criterios de control de calidad
21 de diciembre de 2018
Publicado por primera vez (Actual)
26 de diciembre de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de enero de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
12 de enero de 2021
Última verificación
1 de enero de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes antiarrítmicos
- Depresores del sistema nervioso central
- Agentes del sistema nervioso periférico
- Agentes del sistema sensorial
- Anestésicos
- Moduladores de transporte de membrana
- Anestésicos Locales
- Bloqueadores de canales de sodio activados por voltaje
- Bloqueadores de canales de sodio
- Lidocaína
- Bupivacaína
Otros números de identificación del estudio
- 2018-9613
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.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
Sí
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. .
Ensayos clínicos sobre Lidocaine Hydrochloride
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University of PecsMedical University of PecsTerminado