Estudio Integral del Dolor Postquirúrgico Tras Cirugía de Pectus o Columna Vertebral
9 de abril de 2024 actualizado por: Children's Hospital Medical Center, Cincinnati
Determinantes genéticos, epigenéticos, psicosociales y biológicos del dolor posquirúrgico tras cirugía de pectus o columna
Este será un estudio prospectivo para determinar la asociación entre genotipos específicos, epigenéticos, factores conductuales, sociales y biológicos, con los fenotipos, definidos por percepción del dolor, dolor posoperatorio, efectos analgésicos, efectos secundarios a los analgésicos perioperatorios, dolor posoperatorio crónico y gen expresión en pacientes después de la reparación del pectus excavatum.
Descripción general del estudio
Estado
Inscripción por invitación
Intervención / Tratamiento
Descripción detallada
Este estudio será un estudio prospectivo clínico.
Es observacional para todos los objetivos excepto con respecto a la Intervención de Meditación, que se limitará a 100 participantes de pectus y 100 de columna (aleatorizados a 50/50 en cada brazo).
Reclutaremos a 600 participantes calificados durante el período de estudio para adquirir los datos necesarios para derivar un modelo predictivo que combine el fenotipo con el genotipo.
Este estudio no interferirá con la atención anestésica o perioperatoria estándar, excepto para la toma de muestras de sangre de una línea permanente y el uso de procedimientos de salud integradores adicionales (orientación de meditación de atención enfocada, así como masajes de rutina y técnicas de respiración) para el grupo de meditación aleatorio. .
El personal de investigación administrará evaluaciones psicosociales y somatosensoriales, así como registrará datos relevantes de los registros médicos de los participantes.
La salud integrativa ayudará a enseñar la meditación de atención enfocada a los participantes de meditación aleatorios en la fase preoperatoria.
Se proporcionarán dispositivos de actigrafía a todos los participantes y MUSETM a los del grupo de meditación aleatorio.
El equipo de dolor, de acuerdo con el Protocolo de Manejo del Dolor Pectus, dirigirá el manejo del dolor perioperatorio.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
600
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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Ohio
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Cincinnati, Ohio, Estados Unidos, 45229
- Cincinnati Childrens Hospital Medical Center
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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 y mayores (Niño, Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Descripción
Criterios de inclusión:
- Niños de 8 años de edad hasta la edad adulta
- Diagnóstico de pectus excavatum o escoliosis idiopática del adolescente
- Programado para reparación endoscópica de pectus excavatum o fusión de columna
Criterio de exclusión:
- Antecedentes o enfermedad renal o hepática activa
- Cirugía mayor que requirió opioides en los últimos 5 años
- Problemas respiratorios graves (como apnea obstructiva del sueño, fibrosis quística, fibrosis pulmonar o neumonía en el último mes)
- Condiciones cardíacas que incluyen, entre otras, enfermedad cardíaca cianótica, ventrículo izquierdo hipoplásico, arritmia, hipertensión con tratamiento continuo, enfermedad de Kawasaki o cardiomiopatías. Se pueden incluir participantes con lesiones o defectos valvulares asintomáticos.
- Antecedentes de convulsiones actualmente tratadas con medicamentos (se pueden incluir participantes sin medicación y sin convulsiones durante más de un año)
- No tomar más de dos medicamentos concomitantes conocidos por inducir o inhibir la actividad de CYP2D6, incluidos paroxetina, fluoxetina, cimetidina y duloxetina
- Necesidad de ventilación posoperatoria o derivación cardíaca intraoperatoria en espera
- IMC >35
- Hembras embarazadas o lactantes
- No hablan inglés
- Retraso definitivo del desarrollo
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: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Sin intervención: Control
Los participantes en el grupo de control recibirán el estándar actual de atención, que incluye una evaluación de las necesidades del participante/familia mediante atención integral después de la cirugía, así como atención médica holística estándar por parte de un especialista en salud holística con licencia/certificado.
No recibirán el protocolo de intervención o entrenamiento de meditación de atención enfocada MUSETM.
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Experimental: Meditación
Los participantes asignados al azar para recibir capacitación en meditación de atención enfocada asistirán a una sesión de capacitación preoperatoria, proporcionada por un especialista en salud holística con licencia/certificado.
El contenido incluirá una explicación apropiada para la edad de la meditación de atención enfocada, usando la respiración como el enfoque; instalación y utilización de la diadema MUSETM; y prácticas experienciales.
El objetivo de la intervención es aumentar la atención plena (es decir, la conciencia de las sensaciones, las emociones y los pensamientos momento a momento, sin juzgar y sin reaccionar), proporcionar estrategias de autorregulación y promover respuestas saludables y adaptativas al estrés.
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Los participantes asignados a la intervención de meditación recibirán capacitación en meditación de atención enfocada antes de la operación y se les alentará a meditar durante 20 minutos por día antes de la cirugía.
En el período postoperatorio de hospitalización, a los participantes se les ofrecerá atención médica holística estándar, refuerzo del entrenamiento de meditación y estímulo para practicar al menos 20 minutos de meditación guiada de atención enfocada con la respiración como enfoque, utilizando la banda para la cabeza MUSETM para bio-retroalimentación, todos los días durante su estancia en el hospital.
Se les pedirá que continúen usando la meditación asistida por neurorretroalimentación MUSETM después del alta hospitalaria, hasta su visita para repetir la prueba del dolor, momento en el cual devolverán la diadema MUSETM.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Trayectoria de la puntuación del dolor
Periodo de tiempo: 1 año
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Los puntajes de dolor se recopilarán antes de la operación hasta 1 año después de la operación.
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1 año
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Los cambios en las puntuaciones psicosociales autoinformadas (que incluyen ansiedad, dolor, afrontamiento, limitación física, etc.)
Periodo de tiempo: 1 año
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Las medidas psicosociales se recopilarán antes de la operación hasta 1 año después de la operación.
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1 año
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Cambios en la variabilidad de la frecuencia cardíaca
Periodo de tiempo: 8 semanas
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La variabilidad de la frecuencia cardíaca se evaluará antes y después de la operación.
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8 semanas
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Cambios en los valores medios de amplitud para las bandas de frecuencia alfa inferior, superior y completa por grupo (intervención/sin intervención) y tiempo (preoperatorio/postoperatorio)
Periodo de tiempo: 8 semanas
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La actividad cerebral se evaluará antes y después de la operación.
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8 semanas
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Cambios en los potenciales de respuesta evocados (ERP) durante la meditación y las tareas de dolor experimental
Periodo de tiempo: 8 semanas
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La actividad cerebral se evaluará antes y después de la operación.
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8 semanas
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Cambios en la eficiencia/duración del sueño (actigrafía) y calidad del sueño autoinformada
Periodo de tiempo: 8 semanas
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La eficiencia y la calidad del sueño se evaluarán antes y después de la operación.
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8 semanas
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Incidencia de las medidas de efectos secundarios
Periodo de tiempo: 72 horas después de la operación
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Las incidencias de depresión respiratoria, sedación, náuseas y vómitos postoperatorios se recogerán durante la fase de recuperación.
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72 horas después de la operación
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Cambios en el umbral del dolor a la presión, modulación condicionada del dolor, discriminación táctil e índice de suma temporal
Periodo de tiempo: 8 semanas
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Las pruebas sensoriales cuantitativas se evaluarán antes y después de la operación.
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8 semanas
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Vidya Chidambaran, MD, Children's Hospital Medical Center, Cincinnati
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
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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)
6 de julio de 2018
Finalización primaria (Estimado)
31 de diciembre de 2024
Finalización del estudio (Estimado)
31 de diciembre de 2024
Fechas de registro del estudio
Enviado por primera vez
20 de septiembre de 2018
Primero enviado que cumplió con los criterios de control de calidad
23 de julio de 2019
Publicado por primera vez (Actual)
24 de julio de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de abril de 2024
Última actualización enviada que cumplió con los criterios de control de calidad
9 de abril de 2024
Última verificación
1 de enero de 2024
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Complicaciones Postoperatorias
- Dolor
- Manifestaciones neurológicas
- Anomalías congénitas
- Enfermedades musculoesqueléticas
- Enfermedades de la columna
- Enfermedades óseas
- Curvaturas de la columna
- Anomalías musculoesqueléticas
- Enfermedades óseas del desarrollo
- Dolor Postoperatorio
- Escoliosis
- Cofre embudo
Otros números de identificación del estudio
- 2017-5817
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Los datos no identificados pueden compartirse con almacenes/investigadores de datos internos o externos adicionales.
Estos incluyen, entre otros, el protocolo i2b2-Research Data Warehouse en CCHMC (IRB 2008-0834) con el fin de vincular estos datos a copias anónimas de los registros médicos electrónicos de los participantes a través de una base de datos i2b2.
La base de datos i2b2 anonimizada resultante no formará parte de esta investigación y se utilizará para explorar fenotipos secundarios en futuros estudios de investigación y NIH-db-GaP (Base de datos de genotipos y fenotipos).
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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