Estudo abrangente da dor pós-cirúrgica após cirurgia de pectus ou coluna
11 de junho de 2025 atualizado por: Children's Hospital Medical Center, Cincinnati
Determinantes genéticos, epigenéticos, psicossociais e biológicos da dor pós-cirúrgica após cirurgia de pectus ou coluna
Este será um estudo prospectivo para determinar a associação entre genótipos específicos, fatores epigenéticos, comportamentais, sociais e biológicos, com os fenótipos, definidos por percepção de dor, dor pós-operatória, efeitos analgésicos, efeitos colaterais de analgésicos perioperatórios, dor pós-operatória crônica e gene expressão em pacientes após reparo de pectus excavatum.
Visão geral do estudo
Status
Ativo, não recrutando
Intervenção / Tratamento
Descrição detalhada
Este estudo será um estudo prospectivo clínico.
É observacional para todos os objetivos, exceto no que diz respeito à Intervenção de Meditação, que será limitada a 100 pectus e 100 participantes da coluna (randomizados para 50/50 em cada braço).
Recrutaremos 600 participantes qualificados durante o período do estudo para adquirir os dados necessários para derivar um modelo preditivo que corresponda fenótipo ao genótipo.
Este estudo não interferirá com os cuidados anestésicos ou perioperatórios padrão, exceto para coleta de sangue de uma linha interna e o uso de procedimentos de saúde integrativos adicionais (orientação de meditação de atenção focada, bem como massagem de rotina e técnicas de respiração) para o grupo de meditação randomizado .
A equipe de pesquisa administrará avaliações psicossociais e somatossensoriais, bem como registrará dados relevantes dos registros médicos dos participantes.
A saúde integrativa ajudará no ensino da meditação de atenção focada para os participantes da meditação randomizada na fase pré-operatória.
Dispositivos de actigrafia serão fornecidos a todos os participantes e MUSETM para aqueles no grupo de meditação aleatória.
A equipe de dor, de acordo com o Protocolo de Manejo da Dor Pectus, direcionará o manejo da dor perioperatória.
Tipo de estudo
Intervencional
Inscrição (Estimado)
600
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45229
- Cincinnati Childrens Hospital Medical Center
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
8 anos e mais velhos (Filho, Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Descrição
Critério de inclusão:
- Crianças de 8 anos de idade até a idade adulta
- Diagnóstico de pectus excavatum ou escoliose idiopática do adolescente
- Agendado para reparo endoscópico de pectus excavatum ou fusão da coluna
Critério de exclusão:
- História ou doença renal ou hepática ativa
- Cirurgia de grande porte requerendo opioides nos últimos 5 anos
- Problemas respiratórios graves (como apneia obstrutiva do sono, fibrose cística, fibrose pulmonar ou pneumonia no último mês)
- Condições cardíacas incluindo, mas não limitadas a, doença cardíaca cianótica, ventrículo esquerdo hipoplásico, arritmia, hipertensão com tratamento contínuo, doença de Kawasaki ou cardiomiopatias. Participantes com lesões ou defeitos valvares assintomáticos podem ser incluídos
- Histórico de convulsões atualmente tratadas com medicamentos (participantes sem medicação e sem convulsões por mais de um ano podem ser incluídos)
- Não tomar mais de dois medicamentos concomitantes conhecidos por induzir ou inibir a atividade do CYP2D6, incluindo paroxetina, fluoxetina, cimetidina e duloxetina
- Necessitando de ventilação pós-operatória ou de bypass cardíaco intraoperatório
- IMC >35
- Mulheres grávidas ou amamentando
- não fala inglês
- Atraso de desenvolvimento definido
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Sem intervenção: Ao controle
Os participantes do grupo de controle receberão o padrão de atendimento atual, que inclui uma avaliação das necessidades do participante/família por meio de atendimento integrado após a cirurgia, bem como atendimento de saúde holístico padrão por um especialista em saúde holístico licenciado/certificado.
Eles não receberão o treinamento de meditação de atenção focada MUSETM ou o protocolo de intervenção.
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Experimental: Meditação
Os participantes randomizados para receber treinamento de meditação de atenção focada participarão de uma sessão de treinamento pré-operatório, fornecida por um especialista em saúde holística licenciado/certificado.
O conteúdo incluirá uma explicação apropriada para a idade da meditação de atenção focada, usando a respiração como foco; configuração e utilização da faixa de cabeça MUSETM; e práticas experienciais.
O objetivo da intervenção é aumentar a atenção plena (ou seja, consciência momento a momento, sem julgamento e não reativa de sensações, emoções e pensamentos), fornecer estratégias de autorregulação e promover respostas saudáveis e adaptativas ao estresse.
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Os participantes designados para a intervenção de Meditação receberão treinamento de meditação de atenção focada no pré-operatório e serão encorajados a meditar por 20 minutos por dia antes da cirurgia.
No período pós-operatório de internação, os participantes receberão cuidados de saúde holísticos padrão, reforço do treinamento de meditação e incentivo para praticar pelo menos 20 minutos de meditação guiada de atenção focada com a respiração como foco, utilizando a faixa de cabeça MUSETM para biofeedback, todos os dias durante a internação.
Eles serão solicitados a continuar usando a meditação assistida por neurofeedback MUSETM após a alta hospitalar, até a visita para repetir o teste de dor, momento em que devolverão a faixa de cabeça MUSETM.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Trajetória da pontuação da dor
Prazo: 1 ano
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Os escores de dor serão coletados no pré-operatório até 1 ano após a cirurgia
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1 ano
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Mudanças nos escores psicossociais auto-relatados (incluindo ansiedade, dor, enfrentamento, limitação física, etc.)
Prazo: 1 ano
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Medidas psicossociais serão coletadas no pré-operatório até 1 ano após a cirurgia
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1 ano
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Alterações na variabilidade da frequência cardíaca
Prazo: 8 semanas
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A variabilidade da frequência cardíaca será avaliada no pré e pós-operatório
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8 semanas
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Alterações nos valores médios de amplitude para bandas de frequência alfa inferior, superior e inteira por grupo (intervenção/sem intervenção) e tempo (pré-cirurgia/pós-cirurgia)
Prazo: 8 semanas
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A atividade cerebral será avaliada no pré e pós-operatório
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8 semanas
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Alterações nos potenciais evocados de resposta (ERPs) durante a meditação e tarefas experimentais de dor
Prazo: 8 semanas
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A atividade cerebral será avaliada no pré e pós-operatório
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8 semanas
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Alterações na eficiência/duração do sono (actigrafia) e na qualidade do sono autorreferida
Prazo: 8 semanas
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A eficiência e a qualidade do sono serão avaliadas no pré e pós-operatório
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8 semanas
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Incidência de medidas de efeitos colaterais
Prazo: 72 horas de pós-operatório
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Incidências de depressão respiratória, sedação, náuseas e vômitos pós-operatórios serão coletadas durante a fase de recuperação
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72 horas de pós-operatório
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Alterações no limiar de dor à pressão, modulação da dor condicionada, discriminação tátil e índice de soma temporal
Prazo: 8 semanas
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O teste sensorial quantitativo será avaliado no pré-operatório e no pós-operatório
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8 semanas
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Vidya Chidambaran, MD, Children's Hospital Medical Center, Cincinnati
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
6 de julho de 2018
Conclusão Primária (Estimado)
31 de dezembro de 2025
Conclusão do estudo (Estimado)
31 de dezembro de 2025
Datas de inscrição no estudo
Enviado pela primeira vez
20 de setembro de 2018
Enviado pela primeira vez que atendeu aos critérios de CQ
23 de julho de 2019
Primeira postagem (Real)
24 de julho de 2019
Atualizações de registro de estudo
Última Atualização Postada (Real)
13 de junho de 2025
Última atualização enviada que atendeu aos critérios de controle de qualidade
11 de junho de 2025
Última verificação
1 de junho de 2025
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Dor
- Manifestações Neurológicas
- Doenças ósseas
- Doenças musculoesqueléticas
- Complicações pós-operatórias
- Processos Patológicos
- Doenças da coluna vertebral
- Anormalidades musculoesqueléticas
- Anomalias congénitas
- Doenças Ósseas do Desenvolvimento
- Curvaturas da coluna vertebral
- Dor, Pós-operatório
- Escoliose
- Baú do Funil
Outros números de identificação do estudo
- 2017-5817
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
Os dados não identificados podem ser compartilhados com depósitos/investigadores de dados internos ou externos adicionais.
Isso inclui, entre outros, o protocolo i2b2-Research Data Warehouse no CCHMC (IRB 2008-0834) com o objetivo de vincular esses dados a cópias não identificadas dos registros médicos eletrônicos dos participantes por meio de um banco de dados i2b2.
O banco de dados i2b2 não identificado resultante não fará parte desta pesquisa e será usado para explorar fenótipos secundários em pesquisas futuras e no NIH-db-GaP (Banco de Dados de Genótipos e Fenótipos).
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .