Omfattende undersøgelse af post-kirurgiske smerter efter pectus- eller rygsøjlekirurgi
11. juni 2025 opdateret af: Children's Hospital Medical Center, Cincinnati
Genetiske, epigenetiske, psykosociale og biologiske determinanter for postkirurgiske smerter efter pectus- eller rygsøjlekirurgi
Dette vil være en prospektiv undersøgelse for at bestemme sammenhængen mellem specifikke genotyper, epigenetik, adfærdsmæssige, sociale og biologiske faktorer, med fænotyperne, defineret ved smerteopfattelse, postoperativ smerte, smertestillende virkninger, bivirkninger til perioperative analgetika, kronisk postoperativ smerte og gener ekspression hos patienter efter pectus excavatum reparation.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Intervention / Behandling
Detaljeret beskrivelse
Denne undersøgelse vil være en klinisk prospektiv undersøgelse.
Det er observationelt for alle formål undtagen med hensyn til meditationsinterventionen, som vil være begrænset til 100 pectus- og 100 rygsøjledeltagere (randomiseret til 50/50 i hver arm).
Vi vil rekruttere 600 kvalificerende deltagere i løbet af undersøgelsesperioden for at erhverve de nødvendige data til at udlede en forudsigelig model, der matcher fænotype til genotype.
Denne undersøgelse vil ikke interferere med standardbedøvelse eller perioperativ behandling bortset fra blodprøvetagning fra en indlagt linje og brugen af yderligere integrerede sundhedsprocedurer (meditationsvejledning med fokuseret opmærksomhed, samt rutinemæssige massage- og vejrtrækningsteknikker) for den randomiserede meditationsgruppe .
Forskningspersonale vil administrere psykosociale og somatosensoriske vurderinger, samt registrere relevante data fra deltagerens journaler.
Integrativ sundhed vil hjælpe med at undervise fokuseret opmærksomhed meditation til de randomiserede meditationsdeltagere i den præoperative fase.
Aktigrafiudstyr vil blive udleveret til alle deltagere og MUSETM til dem i den randomiserede meditationsgruppe.
Smerteteamet vil i overensstemmelse med Pectus Pain Management Protocol lede perioperativ smertebehandling.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
600
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45229
- Cincinnati Childrens Hospital Medical Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
8 år og ældre (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- Børn i alderen 8 år til og med voksenalderen
- Diagnose af pectus excavatum eller adolescent idiopatisk skoliose
- Planlagt til endoskopisk pectus excavatum reparation eller rygsøjlefusion
Ekskluderingskriterier:
- Anamnese med eller aktiv nyre- eller leversygdom
- Større operation med behov for opioider inden for de sidste 5 år
- Alvorlige luftvejsproblemer (såsom obstruktiv søvnapnø, cystisk fibrose, lungefibrose eller lungebetændelse inden for den sidste måned)
- Hjertetilstande, herunder, men ikke begrænset til, cyanotisk hjertesygdom, hypoplastisk venstre ventrikel, arytmi, hypertension med igangværende behandling, Kawasakis sygdom eller kardiomyopatier. Deltagere med asymptomatiske klaplæsioner eller -defekter kan inkluderes
- Anamnese med anfald, der i øjeblikket behandles med medicin (deltagere uden medicin og anfaldsfri i mere end et år kan inkluderes)
- Tager ikke mere end to samtidige lægemidler, der vides at inducere eller hæmme CYP2D6-aktivitet, inklusive paroxetin, fluoxetin, cimetidin og duloxetin
- Har brug for postoperativ ventilation eller intraoperativ hjertebypass standby
- BMI >35
- Gravide eller ammende kvinder
- Ikke-engelsktalende
- Klar udviklingsforsinkelse
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Ingen indgriben: Styring
Deltagerne i kontrolgruppen vil modtage den nuværende standardbehandling, som omfatter en vurdering af deltagerens/familiens behov ved integrativ pleje efter operationen, samt standard holistisk sundhedspleje af en autoriseret/certificeret holistisk sundhedsspecialist.
De vil ikke modtage MUSETM fokuseret opmærksomhed meditationstræning eller interventionsprotokol.
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Eksperimentel: Meditation
Deltagere, der er randomiseret til at modtage fokuseret opmærksomhed meditationstræning vil deltage i en præoperativ træningssession, leveret af en autoriseret/certificeret holistisk sundhedsspecialist.
Indholdet vil omfatte en alderssvarende forklaring på fokuseret opmærksomhedsmeditation, med åndedræt som fokus; opsætning og brug af MUSETM hovedbåndet; og erfaringsbaserede praksisser.
Målet med interventionen er at øge mindfulness (dvs. øjeblik-til-øjeblik, ikke-fordømmende og ikke-reaktiv bevidsthed om sansninger, følelser og tanker), give selvreguleringsstrategier og fremme sunde og adaptive reaktioner på stress.
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Deltagere, der tildeles meditationsinterventionen, vil modtage fokuseret opmærksomhedsmeditationstræning præoperativt og opfordret til at meditere i 20 minutter om dagen før operationen.
I den postoperative indlæggelsesperiode vil deltagerne blive tilbudt standard holistisk sundhedspleje, forstærkning af meditationstræning og opmuntring til at praktisere mindst 20 minutters guidet fokuseret opmærksomhed meditation med åndedræt som deres fokus, ved at bruge MUSETM pandebåndet til bio-feedback, hver dag under deres hospitalsophold.
De vil blive bedt om at fortsætte med at bruge MUSETM neurofeedback-assisteret meditation efter hospitalsudskrivning, indtil deres besøg for at gentage smertetest, hvorefter de vil returnere MUSETM pandebåndet.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Smerte score bane
Tidsramme: 1 år
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Smertescore vil blive indsamlet præoperativt gennem 1 år postoperativt
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1 år
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Ændringer i selvrapporterede psykosociale scores (inklusive angst, smerte, mestring, fysiske begrænsninger osv.)
Tidsramme: 1 år
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Psykosociale tiltag vil blive indsamlet præoperativt gennem 1 år postoperativt
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1 år
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Ændringer i pulsvariabilitet
Tidsramme: 8 uger
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Hjertefrekvensvariabilitet vil blive vurderet præoperativt og postoperativt
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8 uger
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Ændringer i middelamplitudeværdier for nedre, øvre og hele alfa-frekvensbånd efter gruppe (intervention/ingen intervention) og tid (før-kirurgi/post-kirurgi)
Tidsramme: 8 uger
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Hjerneaktivitet vil blive vurderet præoperativt og postoperativt
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8 uger
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Ændringer i fremkaldte responspotentialer (ERP'er) under meditation og eksperimentelle smerteopgaver
Tidsramme: 8 uger
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Hjerneaktivitet vil blive vurderet præoperativt og postoperativt
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8 uger
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Ændringer i søvneffektivitet/-varighed (aktigrafi) og selvrapporteret søvnkvalitet
Tidsramme: 8 uger
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Søvneffektivitet og kvalitet vil blive vurderet præoperativt og postoperativt
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8 uger
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Forekomst af bivirkninger
Tidsramme: 72 timer postoperativt
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Forekomster af respirationsdepression, sedation, postoperativ kvalme og opkastning vil blive indsamlet i genopretningsfasen
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72 timer postoperativt
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Ændringer i tryksmertetærskel, betinget smertemodulering, taktil diskrimination og temporalt summationsindeks
Tidsramme: 8 uger
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Kvantitativ sensorisk testning vil blive vurderet præoperativt og postoperativt
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8 uger
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Vidya Chidambaran, MD, Children's Hospital Medical Center, Cincinnati
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
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Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
6. juli 2018
Primær færdiggørelse (Anslået)
31. december 2025
Studieafslutning (Anslået)
31. december 2025
Datoer for studieregistrering
Først indsendt
20. september 2018
Først indsendt, der opfyldte QC-kriterier
23. juli 2019
Først opslået (Faktiske)
24. juli 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. juni 2025
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. juni 2025
Sidst verificeret
1. juni 2025
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2017-5817
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
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Den resulterende afidentificerede i2b2-database vil ikke være en del af denne forskning og vil blive brugt til at udforske sekundære fænotyper i fremtidige forskningsstudier og NIH-db-GaP (Database of Genotypes and Phenotypes).
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produkt fremstillet i og eksporteret fra U.S.A.
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