Uitgebreide studie van postoperatieve pijn na pectus- of wervelkolomchirurgie
9 april 2024 bijgewerkt door: Children's Hospital Medical Center, Cincinnati
Genetische, epigenetische, psychosociale en biologische determinanten van postoperatieve pijn na pectus- of wervelkolomchirurgie
Dit zal een prospectieve studie zijn om de associatie te bepalen tussen specifieke genotypen, epigenetica, gedrags-, sociale en biologische factoren, met de fenotypes, gedefinieerd door pijnperceptie, postoperatieve pijn, analgetische effecten, bijwerkingen van perioperatieve analgetica, chronische postoperatieve pijn en genen. expressie bij patiënten na reparatie van pectus excavatum.
Studie Overzicht
Toestand
Aanmelden op uitnodiging
Interventie / Behandeling
Gedetailleerde beschrijving
Deze studie zal een klinische prospectieve studie zijn.
Het is observerend voor alle doeleinden behalve met betrekking tot de Meditatie-interventie, die beperkt zal zijn tot 100 pectus- en 100 ruggengraatdeelnemers (gerandomiseerd tot 50/50 in elke arm).
We zullen gedurende de studieperiode 600 gekwalificeerde deelnemers rekruteren om de nodige gegevens te verzamelen om een voorspellend model af te leiden dat fenotype en genotype koppelt.
Deze studie zal de standaard anesthesie of peri-operatieve zorg niet verstoren, behalve bloedafname van een inwonende lijn en het gebruik van aanvullende integratieve gezondheidsprocedures (gerichte aandachtsmeditatiebegeleiding, evenals routinematige massage en ademhalingstechnieken) voor de gerandomiseerde meditatiegroep .
Onderzoekspersoneel zal psychosociale en somatosensorische beoordelingen uitvoeren en relevante gegevens uit de medische dossiers van de deelnemers vastleggen.
Integratieve gezondheid zal helpen bij het aanleren van meditatie met gerichte aandacht aan de gerandomiseerde meditatiedeelnemers in de preoperatieve fase.
Actigrafie-apparaten worden verstrekt aan alle deelnemers en MUSETM aan degenen in de gerandomiseerde meditatiegroep.
Het pijnteam zal, conform het Pectus Pain Management Protocol, de perioperatieve pijnbestrijding aansturen.
Studietype
Ingrijpend
Inschrijving (Geschat)
600
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Ohio
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Cincinnati, Ohio, Verenigde Staten, 45229
- Cincinnati Childrens Hospital Medical Center
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
8 jaar en ouder (Kind, Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusiecriteria:
- Kinderen van 8 jaar tot volwassenheid
- Diagnose van pectus excavatum of idiopathische scoliose bij adolescenten
- Gepland voor endoscopisch herstel van pectus excavatum of fusie van de wervelkolom
Uitsluitingscriteria:
- Geschiedenis van of actieve nier- of leverziekte
- Grote operatie waarbij opioïden nodig waren in de afgelopen 5 jaar
- Ernstige ademhalingsproblemen (zoals obstructieve slaapapneu, cystische fibrose, longfibrose of longontsteking in de afgelopen maand)
- Hartaandoeningen, waaronder, maar niet beperkt tot, cyanotische hartziekte, hypoplastische linkerventrikel, aritmie, hypertensie met lopende behandeling, de ziekte van Kawasaki of cardiomyopathieën. Deelnemers met asymptomatische kleplaesies of defecten kunnen worden opgenomen
- Geschiedenis van aanvallen die momenteel met medicatie worden behandeld (deelnemers zonder medicatie en aanvalsvrij gedurende meer dan een jaar kunnen worden opgenomen)
- Niet meer dan twee gelijktijdige geneesmiddelen gebruiken waarvan bekend is dat ze CYP2D6-activiteit induceren of remmen, waaronder paroxetine, fluoxetine, cimetidine en duloxetine
- Noodzaak van postoperatieve beademing of intraoperatieve cardiale bypass stand-by
- BMI >35
- Zwangere vrouwen of vrouwen die borstvoeding geven
- Niet-Engels sprekend
- Duidelijke ontwikkelingsachterstand
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Geen tussenkomst: Controle
Deelnemers aan de controlegroep krijgen huidige zorgstandaard, waaronder een beoordeling van de behoeften van de deelnemer/familie door integrale zorg na de operatie, evenals standaard holistische gezondheidszorg door een gediplomeerde/gecertificeerde holistische gezondheidsspecialist.
Ze zullen niet de MUSETM gerichte aandachtsmeditatietraining of het interventieprotocol ontvangen.
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Experimenteel: Meditatie
Deelnemers die gerandomiseerd zijn om gerichte aandachtsmeditatietraining te krijgen, zullen een preoperatieve trainingssessie bijwonen, gegeven door een gediplomeerde/gecertificeerde holistische gezondheidsspecialist.
De inhoud zal een voor de leeftijd geschikte uitleg bevatten van meditatie met gerichte aandacht, waarbij de adem als focus wordt gebruikt; opstelling en gebruik van de MUSETM-hoofdband; en ervaringspraktijken.
Het doel van de interventie is om mindfulness te vergroten (d.w.z. van moment tot moment, niet-oordelend en niet-reactief bewustzijn van gewaarwordingen, emoties en gedachten), zelfreguleringsstrategieën te bieden en gezonde en adaptieve reacties op stress te bevorderen.
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Deelnemers die aan de meditatie-interventie zijn toegewezen, krijgen preoperatief gerichte aandachtsmeditatietraining en worden aangemoedigd om vóór de operatie 20 minuten per dag te mediteren.
In de postoperatieve klinische periode krijgen de deelnemers standaard holistische gezondheidszorg, versterking van meditatietraining en aanmoediging om ten minste 20 minuten geleide gerichte aandachtsmeditatie te oefenen met adem als focus, met behulp van de MUSETM-hoofdband voor biofeedback, elke dag tijdens hun verblijf in het ziekenhuis.
Ze zullen worden gevraagd om de MUSETM neurofeedback-geassisteerde meditatie te blijven gebruiken na ontslag uit het ziekenhuis, tot hun bezoek voor een herhaalde pijntest, waarna ze de MUSETM-hoofdband teruggeven.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Pijnscore traject
Tijdsspanne: 1 jaar
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Pijnscores worden preoperatief verzameld tot 1 jaar postoperatief
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1 jaar
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Veranderingen in zelfgerapporteerde psychosociale scores (inclusief angst, pijn, coping, fysieke beperking, enz.)
Tijdsspanne: 1 jaar
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Psychosociale maatregelen zullen preoperatief tot 1 jaar postoperatief worden verzameld
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1 jaar
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Veranderingen in hartslagvariabiliteit
Tijdsspanne: 8 weken
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De hartslagvariabiliteit wordt preoperatief en postoperatief beoordeeld
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8 weken
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Veranderingen in gemiddelde amplitudewaarden voor onderste, bovenste en volledige alfafrequentiebanden per groep (interventie/geen interventie) en tijd (vóór de operatie/postoperatie)
Tijdsspanne: 8 weken
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De hersenactiviteit wordt preoperatief en postoperatief beoordeeld
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8 weken
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Veranderingen in evoked response potentials (ERP's) tijdens meditatie en experimentele pijntaken
Tijdsspanne: 8 weken
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De hersenactiviteit wordt preoperatief en postoperatief beoordeeld
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8 weken
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Veranderingen in slaapefficiëntie/duur (actigrafie) en zelfgerapporteerde slaapkwaliteit
Tijdsspanne: 8 weken
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Slaapefficiëntie en -kwaliteit worden preoperatief en postoperatief beoordeeld
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8 weken
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Incidentie van neveneffectmaatregelen
Tijdsspanne: 72 uur postoperatief
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Incidenten van ademhalingsdepressie, sedatie, postoperatieve misselijkheid en braken worden verzameld tijdens de herstelfase
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72 uur postoperatief
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Veranderingen in drukpijndrempel, geconditioneerde pijnmodulatie, tactiele discriminatie en temporele sommatie-index
Tijdsspanne: 8 weken
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Kwantitatief sensorisch onderzoek zal preoperatief en postoperatief worden beoordeeld
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8 weken
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Vidya Chidambaran, MD, Children's Hospital Medical Center, Cincinnati
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
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Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
6 juli 2018
Primaire voltooiing (Geschat)
31 december 2024
Studie voltooiing (Geschat)
31 december 2024
Studieregistratiedata
Eerst ingediend
20 september 2018
Eerst ingediend dat voldeed aan de QC-criteria
23 juli 2019
Eerst geplaatst (Werkelijk)
24 juli 2019
Updates van studierecords
Laatste update geplaatst (Werkelijk)
10 april 2024
Laatste update ingediend die voldeed aan QC-criteria
9 april 2024
Laatst geverifieerd
1 januari 2024
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2017-5817
Plan Individuele Deelnemersgegevens (IPD)
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JA
Beschrijving IPD-plan
Geanonimiseerde gegevens kunnen worden gedeeld met aanvullende interne of externe datawarehouses/onderzoekers.
Deze omvatten, maar zijn niet beperkt tot, het i2b2-Research Data Warehouse-protocol bij CCHMC (IRB 2008-0834) met als doel deze gegevens te koppelen aan geanonimiseerde kopieën van de elektronische medische dossiers van de deelnemers via een i2b2-database.
De resulterende geanonimiseerde i2b2-database zal geen deel uitmaken van dit onderzoek en zal worden gebruikt om secundaire fenotypes te onderzoeken in toekomstige onderzoeksstudies en de NIH-db-GaP (Database of Genotypes and Phenotypes).
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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Klinische onderzoeken op Meditatie
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Medstar Health Research InstituteVoltooidPijn en hysteroscopieVerenigde Staten