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Online "Pain, Stress & Emotions" Class in Chronic Pain

12. maj 2022 opdateret af: Maisa Ziadni, Stanford University

Online "Pain, Stress & Emotions" Class in Chronic Pain: Single-arm Efficacy Test

Members with chronic pain will be invited to participate in a 2-hour zoom-delivered pain psychology class entitled "Pain, Stress, & Emotions". Surveys are completed at baseline (prior to the online class), a satisfaction survey is completed after the class, and post-treatment surveys completed 2, 4, 8, and 12 1weeks after class attendance.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

120

Fase

  • Tidlig fase 1

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • California
      • Palo Alto, California, Forenede Stater, 94304
        • Rekruttering
        • Stanford University
        • Kontakt:

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 til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Chronic pain condition (pain > 3 months)
  • Access to the internet
  • English fluency

Exclusion Criteria:

  • Ongoing legal action or disability claim
  • Cognitive impairment, non-English speaking, or psychological factors that would preclude comprehension of material and/or full participation in the study.

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Pain, Stress, & Emotions Class
No active or placebo comparator will be used. This is a single-arm study design.
Adfærdsmæssigt: Pain, Stress and Emotions
2-hour, zoom-delivered, group intervention focused on teaching patients how pain is processed in their brain and learning about the role of psychosocial factors in their pain conditions.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain Intensity NRS
Tidsramme: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Self-reported pain intensity rating
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient-Reported Outcomes Measurement Information System: Pain Interference short form 6a
Tidsramme: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
self-reported pain interference levels
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Patient-Reported Outcomes Measurement Information System: Depression 6a
Tidsramme: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
self-reported depression
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Patient-Reported Outcomes Measurement Information System: Anxiety 6a
Tidsramme: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
self-reported anxiety
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Patient-Reported Outcomes Measurement Information System: Physical Function 8b
Tidsramme: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
self-reported physical functioning
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Patient-Reported Outcomes Measurement Information System: Sleep Disturbance 6a
Tidsramme: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
self-reported sleep disturbance
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Patient-Reported Outcomes Measurement Information System: social isolation 6a
Tidsramme: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
self-reported social isolation
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Patient-Reported Outcomes Measurement Information System: fatigue 6a
Tidsramme: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
self-reported fatigue
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Patient-Reported Outcomes Measurement Information System: anger 5a
Tidsramme: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
self-reported anger
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Ambivalence over Emotional Expression (AEQ)
Tidsramme: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
self-reported ambivalence levels about emotional expression
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Emotion-Approach Coping
Tidsramme: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
8-item emotion approach coping scale
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Pain Bothersomeness
Tidsramme: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
single-item assessing self-reported levels of pain bothersomeness
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain Attributions Questionnaires
Tidsramme: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Two self-report questionnaires were developed to assess psychological and brain influences on pain. The 4-item psychological attribution scale assesses patients' beliefs that their thoughts and feelings and psychological therapy impacts pain, and the 3-item brain attribution scale assesses patient's beliefs that their pain is brain-based. Mean scores will be computed for both scales separately (0-4; higher scores indicating greater belief that pain is a brain-related [brain attribution] construct and that pain is affected by thoughts, feelings, and psychological interventions [psychological attribution])
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Pain Catastrophizing Scores; measured with Pain Catastrophizing Scale
Tidsramme: Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)
Pain Catastrophizing Scale (Sullivan et al., 1995): A summed score of the 13 catastrophizing items will be computed (0-52, higher scores indicate greater catastrophizing)
Change from baseline to 1-Month follow-up (with secondary 2-month follow-up)

Samarbejdspartnere og efterforskere

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

Sponsor

Stanford University

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)

20. august 2021

Primær færdiggørelse (Forventet)

20. september 2023

Studieafslutning (Forventet)

20. december 2023

Datoer for studieregistrering

Først indsendt

12. august 2021

Først indsendt, der opfyldte QC-kriterier

18. august 2021

Først opslået (Faktiske)

20. august 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. maj 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. maj 2022

Sidst verificeret

1. maj 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • StanfordClass

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Kronisk smerte

Kliniske forsøg med Pain, Stress and Emotions

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Dominican Republic

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner