Psychosocial Support for Pre-operative Pain and Distress (Mind-Body JRA)
23. maj 2020 opdateret af: Eric Garland, University of Utah
The purpose of this randomized study is to determine the impact of three different types of psychosocial support delivered by mental health professionals to pre-operative joint replacement patients.
This study will examine the differential effects of brief mindfulness training, hypnostic suggestion, and cognitive behavioral pain psychoeducation for pre-operative patients, with a supplemental nonrandomized usual care comparison group.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
727
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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Utah
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Salt Lake City, Utah, Forenede Stater, 84112
- University of Utah
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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
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 the Joint Replacement 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: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Mindfulness
15 minute mindfulness session
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The 15 minute mindfulness session is a scripted mindfulness exercise that incorporates mindfulness principles of intentionally paying attention to present-moment experience in a non-judgmental fashion.
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Eksperimentel: Suggestion
15 minute therapeutic suggestion session
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The 15 minute suggestion session is a scripted suggestion exercise that incorporates imagery and suggestions for changes in cognition, emotion, and body sensations.
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Aktiv komparator: Psychoeducation
15 minute psychoeducation session
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The 15 minute psychoeducation session is a supportive session in which behavioral coping strategies for pain management are discussed.
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Ingen indgriben: Usual Care
The usual care comparison group was comprised of patients who underwent total joint arthroplasty of the hip or knee at the same academic medical center during the study period but who did not attend Joint Academy.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain Intensity Numeric Rating Scale
Tidsramme: Immediately prior to and following intervention
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Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable.
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Immediately prior to and following intervention
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Pain Unpleasantness Numeric Rating Scale
Tidsramme: Immediately prior to and following intervention
|
Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.
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Immediately prior to and following intervention
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain Medication Desire Numeric Rating Scale
Tidsramme: Immediately prior to and following intervention
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Single Likert scale item ranging from 0-10, with 0 indicating no desire for pain medication and 10 representing a strong desire for pain medication.
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Immediately prior to and following intervention
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Anxiety Numeric Rating Scale
Tidsramme: Immediately prior to and following intervention
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Single Likert scale item ranging from 0-10, with 0 indicating no anxiety and 10 representing very anxious.
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Immediately prior to and following intervention
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Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0
Tidsramme: During the 6 weeks prioir to surgery and at the 6-week outpatient follow-up appointment.
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The PROMIS physical functioning computer assisted test draws from a bank of 123 items all scored on a 5 point Likert scale. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A high score better physical functioning. |
During the 6 weeks prioir to surgery and at the 6-week outpatient follow-up appointment.
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Nondual Awareness Dimensional Assessment - State
Tidsramme: Immediately prior to and following intervention
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Three Likert scale item ranging from 0-30, with 0 indicating no nondual awareness and 10 representing complete nondual awareness.
Items can also be used individually.
Item one is a single Likert scale item ranging from 0-10, with 0 indicating no relational unity and 10 representing complete relational unity.
Item two is a single Likert scale item ranging from 0-10, with 0 indicating no annihilational unity and 10 representing complete annihilational unity.
Item three is a single Likert scale item ranging from 0-10, with 0 indicating no bliss and 10 representing complete bliss.
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Immediately prior to and following intervention
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Sensation Manikin Body Sensation Report
Tidsramme: Immediately prior to and following intervention
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The ratio of pleasant to unpleasant bodily sensations reported on a sensation manikin.
Ratio scores below 1 indicate unpleasant sensations predominate in the body and ratio scores above 1 indicate pleasant scores predominate.
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Immediately prior to and following intervention
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Present Moment Awareness Numeric Rating Scale (Manipulation Check)
Tidsramme: Immediately prior to and following intervention
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Single Likert scale item ranging from 0-10, with 0 indicating no awareness of the present and 10 representing complete awareness of the present moment.
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Immediately prior to and following intervention
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Decentering Numeric Rating Scale (Manipulation Check)
Tidsramme: Immediately prior to and following intervention
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Single Likert scale item ranging from 0-10, with 0 indicating no decentering and 10 representing a completely decentered perspective.
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Immediately prior to and following intervention
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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.
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)
4. juni 2018
Primær færdiggørelse (Faktiske)
23. september 2019
Studieafslutning (Faktiske)
23. september 2019
Datoer for studieregistrering
Først indsendt
12. juni 2018
Først indsendt, der opfyldte QC-kriterier
7. september 2018
Først opslået (Faktiske)
11. september 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. maj 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. maj 2020
Sidst verificeret
1. maj 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB_00085446
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