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Online Mindfulness-based Stress Reduction Intervention for People With Chronic Pain Waiting for Health Services

20. september 2022 opdateret af: Diana Zidarov, Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Online Mindfulness-based Stress Reduction Intervention for Chronic Pain in Individuals Waiting for Health Care Services: a Study Protocol for a Pilot Randomized Controlled Trial (RCT)

The goal of this project is to explore the feasibility and the efficacy of a online mindfulness-based stress reduction intervention for people with chronic pain waiting for secondary or tertiary health care services

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1V2C8
        • Association québécoise de la douleur chronique
      • Montreal, Quebec, Canada, H4B 1T3
        • Centre de réadaptation Layton-Lethbridge-Mackay
      • Montreal, Quebec, Canada, H4G 2A3
        • Hôpital de Verdun

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 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Men and women aged 18-85
  • Self-reported diagnosis of chronic non-cancer pain
  • Chronic non-cancer pain duration of 3 months or more
  • Chronic non-cancer pain experienced during 4 days or more per week
  • Average pain intensity of 4 or more out of 10 in the last seven days
  • French or English fluency
  • Access to Wi-Fi
  • Be able to attend a weekly two-hour MBSR virtual session for eight consecutive weeks

Exclusion Criteria:

  • Cancer-related chronic pain
  • Currently receiving or have received in the last 24 months coordinated care in pain clinics, hospitals or rehabilitation centers.
  • Current or recent participation (in the last 12 months and more than 12 sessions) of cognitive-behavioral therapy or MBSR program
  • Having an unstable psychological conditions such as depression, bipolar disorder, post-traumatic stress disorder, psychotic disorder

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Mindfulness-based stress reduction intervention
Online 8-week group program, once per week
Adfærdsmæssigt: Mindfulness-based stress reduction
An online mindfulness-based stress reduction intervention will be administered in a group format of maximum 15 participants, once a week for 120 minutes for 8 weeks by an experienced therapist trained in MBSR. Sessions will include sitting and lying meditation, hatha yoga and a body scan where attention is sequentially focused on different parts of the body. Individual autonomous practice between 30-45 minutes, 6 times / week will also be recommended. To support individual autonomous practice, a daily diary and two guided videos (around 35 minutes/each) were created.
Ingen indgriben: Waiting list
Controls will not receive any intervention during this time. They are on chronic pain clinics waiting list

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Participants retention rate
Tidsramme: 2 months
The percentage of participants who have completed the 8 online MBSR sessions
2 months
Participants participation rate
Tidsramme: 12 months
The percentage of participants on waiting lists who agreed to participate in the intervention
12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient-Reported Outcomes Measurement Information System Global-10
Tidsramme: Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
Change in domains of health and functioning as measured by the PROMIS Global-10, score range is 7-35 with increases in scores meaning better outcome
Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
Patient-Reported Outcomes Measurement Information System 29
Tidsramme: Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
Change in 8 health-related quality of life domains as measured by the PROMIS 29. PROMIS-29 is a generic patient reported outcome measure, which includes four items from each of the seven PROMIS domains (physical function, depression, anxiety, fatigue, sleep disturbance, and ability to participate in social roles and activities, pain interference) and a single item on pain intensity. Each item has five response options (values 1 to 5), except for the pain intensity item which has eleven response options (values 0 to 10). A total raw score is computed for each domain as the sum of the response to each question within the domain, leading to seven domain scores, each from 4 to 20.
Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
French-Canadian Chronic Pain Self-Efficacy Scale
Tidsramme: Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
The French-Canadian Chronic Pain Self-Efficacy Scale (Lacasse et al., 2015) is a 6-item scale that measures an individual's confidence in his/her ability to manage chronic pain in general and pain-related symptoms. Items are rated on a 10-point Likert scale ranging from 1 = not at all confident to 10 = entirely confident. Score range is 6-60 with higher scores reflecting greater chronic pain self-efficacy.
Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
Chronic Pain Acceptance Questionnaire
Tidsramme: Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
The Chronic Pain Acceptance Questionnaire (CPAQ-8; Fish et al., 2010 ) is an 8-item scale comprised of two subscales: activity engagement and pain willingness. Items are scored on a 7-point Likert scale ranging from 0 = never true to 6 = always true. Score range is 0-48 with increases in scores meaning better outcome.
Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
Global Rating of Change Scale
Tidsramme: 3-month follow-up (week 21)
The Global Change Rating Scale (11-point visual analogue scale raging from minus 5 to plus 5) will be used to assess the participants' perception of improvement (or decline) in relation to their self-efficacy in manging pain at the end of the MBSR intervention.
3-month follow-up (week 21)
Pain Catastrophizing Scale
Tidsramme: Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
Change in pain catastrophizing as measured by the Pain Catastrophizing Scale (French Canadian version). PCS is a 13-item measure using a 5-point Likert scale (0=not at all, 4=all the time) with score range between 0-52 with decreases in scores meaning better outcome.
Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
Pain Disability Index
Tidsramme: Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
Change in pain disability as measured by the The French-Canadian Pain Disability Index (score range is 0-70 with decreases in scores meaning better outcome)
Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)

Samarbejdspartnere og efterforskere

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

Sponsor

Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

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)

16. juni 2021

Primær færdiggørelse (Faktiske)

20. december 2021

Studieafslutning (Faktiske)

24. januar 2022

Datoer for studieregistrering

Først indsendt

8. april 2021

Først indsendt, der opfyldte QC-kriterier

8. april 2021

Først opslået (Faktiske)

13. april 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. september 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. september 2022

Sidst verificeret

1. september 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CRIR-1499-1120/multi

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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