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

20 settembre 2022 aggiornato da: 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

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • 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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 85 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Mindfulness-based stress reduction intervention
Online 8-week group program, once per week
Comportamentale: 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.
Nessun intervento: Waiting list
Controls will not receive any intervention during this time. They are on chronic pain clinics waiting list

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Participants retention rate
Lasso di tempo: 2 months
The percentage of participants who have completed the 8 online MBSR sessions
2 months
Participants participation rate
Lasso di tempo: 12 months
The percentage of participants on waiting lists who agreed to participate in the intervention
12 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Patient-Reported Outcomes Measurement Information System Global-10
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

16 giugno 2021

Completamento primario (Effettivo)

20 dicembre 2021

Completamento dello studio (Effettivo)

24 gennaio 2022

Date di iscrizione allo studio

Primo inviato

8 aprile 2021

Primo inviato che soddisfa i criteri di controllo qualità

8 aprile 2021

Primo Inserito (Effettivo)

13 aprile 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 settembre 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 settembre 2022

Ultimo verificato

1 settembre 2022

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CRIR-1499-1120/multi

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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