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Preoperative Psychosocial Support for Postoperative Recovery and Health: Mechanistic Substudy

24. august 2020 opdateret af: Adam Hanley, University of Utah
This was a single site, three-arm, parallel group randomized clinical trial that compared the effect of three preoperative psychosocial interventions on knee and hip replacement patients' preoperative pain intensity and postoperative pain intensity, pain unpleasantness, and opioid use.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

118

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84112
        • University of Utah

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • English-speaking males or females.
  • 18 years old or older
  • Patients within the University of Utah Hospital system
  • Patients attending Joint Academy to prepare for either hip or knee replacement surgery

Exclusion Criteria:

  • Altered mental status due to delirium, psychosis, or pharmacological sedation as determined by clinical assessment.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Mindfulness af smerte
Adfærdsmæssigt: Mindfulness of Pain
Mindfulness of Pain consisted of instruction in how to (1) zoom in to deconstruct pain into its constituent physical sensations and precisely map each sensation's spatial location, (2) use mindful breathing to zoom out and broaden the field of attention to include previously neglected sensory elements (i.e., spaces within the body that were absent of sensation and pleasant sensations), and (3) shift attention from unpleasant sensations to neutral/pleasant sensations or experiences.
Eksperimentel: Mindfulness of Breath
Adfærdsmæssigt: Mindfulness of Breath
Mindfulness of Breath consisted of instruction in focused attention on the breath and metacognitive monitoring and acceptance of discursive thoughts, negative emotions, and pain.
Aktiv komparator: Cognitive-Behaviorally Based Pain Psychoeducation
Adfærdsmæssigt: Cognitive-Behaviorally Based Pain Psychoeducation
Cognitive-Behaviorally Based Pain Psychoeducation consisted of psychoeducation about the link between thoughts, emotions, and behavior and provided instruction in the use logic to dispute maladaptive thoughts about pain that might otherwise exacerbate pain and distress.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Preoperative Pain Intensity
Tidsramme: Completed immediately before the preoperative intervention and immediately after the preoperative intervention (i.e., 20 minutes)
Single-item Numeric Rating Scale (0-10), with 0 indicating no pain and 10 representing the most intense pain imaginable.
Completed immediately before the preoperative intervention and immediately after the preoperative intervention (i.e., 20 minutes)
Change in Postoperative Pain Intensity
Tidsramme: Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days.
Single-item Numeric Rating Scale (0-10), with 0 indicating no pain and 10 representing the most intense pain imaginable.
Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Postoperative Pain Unpleasantness
Tidsramme: Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days.
Single-item Numeric Rating Scale (0-10), with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.
Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days.
Change in Postoperative Opioid Use
Tidsramme: Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days.
Single-item, dichotomously scored (no vs. yes): "Did you take opioid medications in the last 24 hours?"
Completed on the evenings of the 2nd, 3rd, 7th, 14th, 21st, and 28th postoperative days.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Self-Transcendent State
Tidsramme: Completed immediately before the preoperative intervention and immediately after the preoperative intervention (i.e., 20 minutes)
Self-transcendent state was measured with the Nondual Awareness Dimensional Assessment (NADAs; Hanley, Nakamura, & Garland, 2018). The NADAs is a 3-item, Likert type (0-10) self-report scale specifically designed to measure alterations in the experience of self occasioned by mindfulness practice.
Completed immediately before the preoperative intervention and immediately after the preoperative intervention (i.e., 20 minutes)
Patient Confidence
Tidsramme: Completed immediately after the preoperative intervention
Patients' confidence ("How confident are you that you could effectively use this pain management technique?") in using the pain management technique was assessed with a single item rated on a numeric rating scale (0-10), with 0 indicating no confidence and 10 representing complete confidence.
Completed immediately after the preoperative intervention
Patient Intent
Tidsramme: Completed immediately after the preoperative intervention
Patients' intent to use the technique ("How likely are you to use this pain management technique?") to use the pain management technique was assessed with a single item rated on a numeric rating scale (0-10), with 0 indicating no intent and 10 representing absolute intent.
Completed immediately after the preoperative intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Utah

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

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)

29. oktober 2019

Primær færdiggørelse (Faktiske)

10. marts 2020

Studieafslutning (Faktiske)

13. august 2020

Datoer for studieregistrering

Først indsendt

13. august 2020

Først indsendt, der opfyldte QC-kriterier

17. august 2020

Først opslået (Faktiske)

20. august 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. august 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. august 2020

Sidst verificeret

1. oktober 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB_00123611

Plan for individuelle deltagerdata (IPD)

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INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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Kliniske forsøg med Smerte

Kliniske forsøg med Mindfulness of Breath

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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