New Educational Tool for FM
Usefulness of a New Educational Tool for Understanding Pain for Fibromyalgia Patients
1 other identifier
interventional
300
1 country
1
Brief Summary
This study aims at analyzing the usefulness of a new educational tool developed by Pain Revolution, a compendium of 9 fact sheets along with a related quiz in patients from the Hospital Vall d'Hebron of Barcelona suffering from fibromyalgia, compared to a non-education group. The present study also aims at comparing the usefulness of the new tool based on PNE in two different formats: read and explained.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 21, 2020
CompletedFirst Submitted
Initial submission to the registry
September 26, 2020
CompletedFirst Posted
Study publicly available on registry
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2021
CompletedOctober 1, 2020
September 1, 2020
1.1 years
September 26, 2020
September 26, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain Revolution Quiz
The Pain Revolution Quiz comprises two main sections: one first section related to the acquired knowledge after the fact sheets and the second section incorporates 4 questions with feedback about the learning process. The first section encompasses 26 items which are used to measure acquired knowledge by the subjects after being provided the 9 fact sheets content. The 26 items are answered on multicomponent choices of three possible alternatives: true, false and I don't know. Total scores can range from 0 to 26. Some of the items respond to reverse score, such as 1, 5, 7, 8, 10, 12, 14, 20, 22, 25, 26. This tool has been recently developed by Pain Revolution, a pain educator network founded by Professor Lorimer Moseley, group leader in Body in Mind Research Group from University of South Australia. The adequate internal consistency and acceptable test-retest reliability is currently being studied. In the same manner, the Spanish version is evaluated for first time in the present study.
Through study completion, an average of 1 week]
Study Arms (3)
PNE-explained group
EXPERIMENTALThe participants in the PNE-explained group will be explained the fact sheets with an explanatory video (due to COVID-19 circumstances) conducted by the therapist M.S. The video will last one hour approximately and it contains a presentation by Mayte Serrat with a view of the fact sheets. This group will be given one week to watch the video and comprehend its content.
PNE-read group
ACTIVE COMPARATORThe PNE-read group will receive the fact sheets via email along with instructions regarding the content and the procedure to read the content. Instructions will suggest to read only two fact sheets per day during 4,5 days. It will be suggested to take 30 minutes at least for each fact sheet.
TAU group
ACTIVE COMPARATORParticipants allocated into this group will maintain treatment as usual (TAU) and will follow the recommendations by their usual health professional.
Interventions
There are 9 fact sheets overall. And each fact sheet incorporates two pages relating to one main concept. The first of two pages introduces the concept, and the second one quotes important ideas that emerge from the main concept. The 9 main concepts and consequent ideas presented in the fact sheets are based on current scientific research in pain science and have been selected and structured specifically for PNE education for chronic pain patients. The fact sheets have been fully developed and designed by Pain Revolution, a pain educator network founded by Professor Lorimer Moseley, group leader in Body in Mind Research Group from University of South Australia.
The PNE-read group will receive the fact sheets via email along with instructions regarding the content and the procedure to read the content. Instructions will suggest to read only two fact sheets per day during 4,5 days. It will be suggested to take 30 minutes at least for each fact sheet.
Participants allocated to this group will maintain treatment as usual (TAU) and will follow the recommendations by their usual health professiona
Eligibility Criteria
You may qualify if:
- Adults from 18 to 75 years-old.
- American College of Rheumatology (ACR) classification criteria + the 2011 modified ACR diagnostic criteria for fibromyalgia
- Able to understand Spanish and accept to participate in the study.
You may not qualify if:
- Participating in concurrent or past RCTs (previous year).
- Comorbidity with severe mental disorders (i.e. psychosis) or neurodegenerative diseases (i.e. Alzheimer) that that would limit the ability of the patient to participate in the RCT.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mayte Serrat
Barcelona, 08023, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lorimer Moseley, PhD
University of South Australia
- STUDY DIRECTOR
Sara Marsall, PhD
Hospital Universitari Vall dHebron
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2020
First Posted
October 1, 2020
Study Start
September 21, 2020
Primary Completion
October 10, 2021
Study Completion
October 10, 2021
Last Updated
October 1, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share