Étude approfondie de la douleur post-chirurgicale après une chirurgie du pectus ou de la colonne vertébrale
9 avril 2024 mis à jour par: Children's Hospital Medical Center, Cincinnati
Déterminants génétiques, épigénétiques, psychosociaux et biologiques de la douleur post-chirurgicale après une chirurgie du pectus ou de la colonne vertébrale
Il s'agira d'une étude prospective visant à déterminer l'association entre des génotypes spécifiques, des facteurs épigénétiques, comportementaux, sociaux et biologiques, avec les phénotypes, définis par la perception de la douleur, la douleur postopératoire, les effets analgésiques, les effets secondaires des analgésiques périopératoires, la douleur postopératoire chronique et le gène expression chez les patients après réparation du pectus excavatum.
Aperçu de l'étude
Statut
Inscription sur invitation
Les conditions
Intervention / Traitement
Description détaillée
Cette étude sera une étude clinique prospective.
Il est observationnel pour tous les objectifs sauf en ce qui concerne l'intervention de méditation, qui sera limitée à 100 pectus et 100 participants à la colonne vertébrale (randomisés à 50/50 dans chaque bras).
Nous recruterons 600 participants qualifiés au cours de la période d'étude pour acquérir les données nécessaires pour dériver un modèle prédictif faisant correspondre le phénotype au génotype.
Cette étude n'interférera pas avec les soins anesthésiques ou périopératoires standard, à l'exception du prélèvement de sang à partir d'une ligne à demeure et de l'utilisation de procédures de santé intégratives supplémentaires (orientation de la méditation avec attention ciblée, ainsi que des techniques de massage et de respiration de routine) pour le groupe de méditation randomisé .
Le personnel de recherche administrera des évaluations psychosociales et somatosensorielles et enregistrera les données pertinentes des dossiers médicaux des participants.
La santé intégrative aidera à enseigner la méditation d'attention focalisée aux participants à la méditation randomisés dans la phase préopératoire.
Des appareils d'actigraphie seront fournis à tous les participants, et MUSETM à ceux du groupe de méditation aléatoire.
L'équipe de la douleur, conformément au protocole de gestion de la douleur Pectus, dirigera la gestion de la douleur périopératoire.
Type d'étude
Interventionnel
Inscription (Estimé)
600
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Ohio
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Cincinnati, Ohio, États-Unis, 45229
- Cincinnati Childrens Hospital Medical Center
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
8 ans et plus (Enfant, Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
La description
Critère d'intégration:
- Enfants âgés de 8 ans à l'âge adulte
- Diagnostic du pectus excavatum ou de la scoliose idiopathique de l'adolescent
- Prévu pour la réparation endoscopique du pectus excavatum ou la fusion de la colonne vertébrale
Critère d'exclusion:
- Antécédents ou maladie rénale ou hépatique active
- Chirurgie majeure nécessitant des opioïdes au cours des 5 dernières années
- Problèmes respiratoires graves (tels que l'apnée obstructive du sommeil, la fibrose kystique, la fibrose pulmonaire ou la pneumonie au cours du dernier mois)
- Affections cardiaques, y compris, mais sans s'y limiter, cardiopathie cyanotique, ventricule gauche hypoplasique, arythmie, hypertension avec traitement en cours, maladie de Kawasaki ou cardiomyopathies. Les participants présentant des lésions ou des défauts valvulaires asymptomatiques peuvent être inclus
- Antécédents de crises actuellement traitées avec des médicaments (les participants sans médicaments et sans crises depuis plus d'un an peuvent être inclus)
- Ne pas prendre plus de deux médicaments concomitants connus pour induire ou inhiber l'activité du CYP2D6, y compris la paroxétine, la fluoxétine, la cimétidine et la duloxétine
- Besoin d'une ventilation postopératoire ou d'une attente de pontage cardiaque peropératoire
- IMC >35
- Femmes enceintes ou allaitantes
- Non anglophone
- Retard de développement certain
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Aucune intervention: Contrôle
Les participants du groupe témoin recevront la norme actuelle de soins, qui comprend une évaluation des besoins du participant/de la famille par des soins intégratifs après la chirurgie, ainsi que des soins de santé holistiques standard par un spécialiste de la santé holistique agréé/certifié.
Ils ne recevront pas la formation à la méditation d'attention focalisée MUSETM ni le protocole d'intervention.
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Expérimental: Méditation
Les participants randomisés pour recevoir une formation à la méditation d'attention ciblée assisteront à une session de formation préopératoire, dispensée par un spécialiste de la santé holistique agréé/certifié.
Le contenu comprendra une explication adaptée à l'âge de la méditation d'attention focalisée, en utilisant la respiration comme objectif ; mise en place et utilisation du bandeau MUSETM ; et les pratiques expérientielles.
Le but de l'intervention est d'augmenter la pleine conscience (c'est-à-dire la conscience instantanée, sans jugement et non réactive des sensations, des émotions et des pensées), de fournir des stratégies d'autorégulation et de promouvoir des réponses saines et adaptatives au stress.
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Les participants affectés à l'intervention de méditation recevront une formation à la méditation avec attention ciblée avant l'opération et seront encouragés à méditer pendant 20 minutes par jour avant la chirurgie.
Au cours de la période d'hospitalisation postopératoire, les participants se verront offrir des soins de santé holistiques standard, un renforcement de la formation à la méditation et des encouragements à pratiquer au moins 20 minutes de méditation guidée à attention focalisée avec le souffle comme objectif, en utilisant le bandeau MUSETM pour le bio-feedback, tous les jours pendant leur séjour à l'hôpital.
Il leur sera demandé de continuer à utiliser la méditation assistée par neurofeedback MUSETM après leur sortie de l'hôpital, jusqu'à leur visite pour répéter le test de la douleur, moment auquel ils rendront le bandeau MUSETM.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Trajectoire du score de douleur
Délai: 1 an
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Les scores de douleur seront collectés avant l'opération jusqu'à 1 an après l'opération
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1 an
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Changements dans les scores psychosociaux autodéclarés (y compris l'anxiété, la douleur, l'adaptation, la limitation physique, etc.)
Délai: 1 an
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Les mesures psychosociales seront recueillies avant l'opération jusqu'à 1 an après l'opération
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1 an
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Changements dans la variabilité de la fréquence cardiaque
Délai: 8 semaines
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La variabilité de la fréquence cardiaque sera évaluée en préopératoire et en postopératoire
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8 semaines
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Changements dans les valeurs d'amplitude moyennes pour les bandes de fréquence alpha inférieures, supérieures et entières par groupe (intervention/aucune intervention) et temps (pré-chirurgie/post-chirurgie)
Délai: 8 semaines
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L'activité cérébrale sera évaluée en préopératoire et en postopératoire
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8 semaines
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Changements dans les potentiels de réponse évoqués (ERP) pendant la méditation et les tâches expérimentales de douleur
Délai: 8 semaines
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L'activité cérébrale sera évaluée en préopératoire et en postopératoire
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8 semaines
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Changements dans l'efficacité/la durée du sommeil (actigraphie) et la qualité du sommeil autodéclarée
Délai: 8 semaines
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L'efficacité et la qualité du sommeil seront évaluées en préopératoire et en postopératoire
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8 semaines
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Incidence des mesures d'effets secondaires
Délai: 72 heures après l'opération
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Les incidences de dépression respiratoire, de sédation, de nausées et de vomissements postopératoires seront recueillies pendant la phase de récupération
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72 heures après l'opération
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Modifications du seuil de douleur à la pression, de la modulation de la douleur conditionnée, de la discrimination tactile et de l'indice de sommation temporelle
Délai: 8 semaines
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Des tests sensoriels quantitatifs seront évalués en préopératoire et en postopératoire
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8 semaines
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chercheur principal: Vidya Chidambaran, MD, Children's Hospital Medical Center, Cincinnati
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
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Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
6 juillet 2018
Achèvement primaire (Estimé)
31 décembre 2024
Achèvement de l'étude (Estimé)
31 décembre 2024
Dates d'inscription aux études
Première soumission
20 septembre 2018
Première soumission répondant aux critères de contrôle qualité
23 juillet 2019
Première publication (Réel)
24 juillet 2019
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
10 avril 2024
Dernière mise à jour soumise répondant aux critères de contrôle qualité
9 avril 2024
Dernière vérification
1 janvier 2024
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Complications postopératoires
- La douleur
- Manifestations neurologiques
- Anomalies congénitales
- Maladies musculo-squelettiques
- Maladies de la colonne vertébrale
- Maladies osseuses
- Courbures vertébrales
- Anomalies musculosquelettiques
- Maladies osseuses, développement
- Douleur, Postopératoire
- Scoliose
- Coffre en entonnoir
Autres numéros d'identification d'étude
- 2017-5817
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
Les données anonymisées peuvent être partagées avec d'autres entrepôts de données/investigateurs internes ou externes.
Ceux-ci incluent, mais sans s'y limiter, le protocole i2b2-Research Data Warehouse au CCHMC (IRB 2008-0834) dans le but de relier ces données à des copies anonymisées des dossiers médicaux électroniques des participants via une base de données i2b2.
La base de données i2b2 anonymisée qui en résulte ne fera pas partie de cette recherche et sera utilisée pour explorer les phénotypes secondaires dans de futures études de recherche et le NIH-db-GaP (base de données de génotypes et de phénotypes).
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Douleur, Postopératoire
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Evergrain, LLCINQUIS Clinical Research Ltd.ComplétéSatiété du pain riche en fibres et riche en protéinesCanada
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Tel-Aviv Sourasky Medical CenterWeizmann Institute of ScienceComplétéChangements de poids corporel | Modification alimentaire | Microbiote gastro-intestinal | Pain | Tests hématologiquesIsraël
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University of BergenUniversity of Leipzig; Chalmers University of Technology; Nofima; Paderborn UniversityComplétéHyperglycémie | Prédiabète | Contrôle glycémique | PainNorvège
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Ege UniversityComplétéObésité | Index glycémique | Glucose sanguin | PainTurquie
Essais cliniques sur Méditation
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Mohamed Mahmoud DohiemRecrutementLe patient perd son oreille et a besoin d'une prothèse auriculaireEgypte