New Educational Tool for FM

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Main objective

A compendium of 9 fact sheets along with a related quiz have been developed in order to provide overall population current pain-science knowledge. The present study aims at analyzing the usefulness of this new tool based on pain neuroscience education (PNE) in patients from the Hospital Vall d'Hebron of Barcelona suffering from fibromyalgia, compared to a non-education group.

Secondary objective

Due to the extended content of the fact sheets, these can be delivered to the patient as a reading material or can be used as a support material in a educational presentation. Therefore, this study also aims at comparing the usefulness of the new tool based on PNE in two different formats: read autonomously by the patient and explained by a pain-science expert to the patient.

This is a tree-arm RCT: TAU group and intervention group with 2 different groups as follows:

The intervention program is divided in two groups. Both groups will be provided with the PNE fact sheets but in different format (read and explained) and will be given one week to comprehend the content before to assess their knowledge. Therefore, intervention groups will be informed that a quiz about the fact sheets will be delivered to each one in order to asses their acquired knowledge.

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04571853
Study type	Interventional
Source	Hospital Universitari Vall d'Hebron Research Institute
Contact	Mayte Serrat, MSc
Phone	+34934893891
Email	mserrat@vhebron.net
Status	Recruiting
Phase	N/A
Start date	September 21, 2020
Completion date	October 10, 2021

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.