Therapeutic Educational Intervention and Fibromyalgia: a Mixed Methods Research

Summary

Fibromyalgia is the most common central sensitivity syndrome and one of the principal causes of chronic widespread pain among the adult population worldwide. Recent studies indicated that poor sleep quality is highly prevalent and a troublesome symptom among patients with fibromyalgia. Psychosocial and behavioral factors have been demonstrated to be intimately related with the symptomatic experience of fibromyalgia patients. Pain catastrophizing and dysfunctional beliefs and attitudes about sleep are involved in the perpetuation of those symptoms and affecting other spheres of the syndrome Objective: The aim of this project is to evaluate the cognitive and behavioral factors related with pain and poor sleep quality in women diagnosed with fibromyalgia so as to develop and test the effects of a web-based therapeutic educational intervention about pain and sleep on pain intensity, pain catastrophizing, sleep quality, dysfunctional beliefs and attitudes about sleep, and quality of life and health status related with fibromyalgia Methods: A mixed methods research with sequential exploratory design will be applied. For the qualitative phase, a snowballing sampling technique will be used. The participants will be invited to participate in a personal semi-structured interview. For the quantitative phase a sample of 64 adult women with fibromyalgia will be recruited from primary care centers of the city of Lleida and randomized into either the intervention or the control group Discussion: There is an imperative necessity of taking patients' symptoms experience as essential for the development of effective symptom management strategies from a biopsychosocial perspective. In the era of the internet, our web-based therapeutic educational intervention could open a new window for the treatment of women with fibromyalgia as part of current FM management treatments in primary care.

Our hypotheses are:

* Cognitive and behavioral factors related to pain and poor sleep quality in women diagnosed with fibromyalgia act as perpetuating factors and aggravate the general health status and the quality of life of these patients.
* A web-based therapeutic educational intervention about pain and poor sleep quality in women diagnosed with FM is better than the conventional approach for the treatment of pain intensity, pain catastrophizing, sleep quality, dysfunctional beliefs and attitudes about sleep, and general health status and quality of life-related with FM.

Conditions

• Fibromyalgia

Interventions

BEHAVIORAL

Web-based Therapeutic Educational Intervention

The subjects assigned to this group will follow a web-based therapeutic educational intervention on pain and poor sleep quality. All the subjects assigned to this intervention will have free access to the website from any device with internet access and will be able to consult it as many times as they wish during the intervention. The intervention will last for four weeks.

OTHER

Conventional Treatment

The subjects assigned to this condition will continue with their usual treatment is based on the recommendations of the clinical practice guideline for the treatment of fibromyalgia "Guide of Fibromyalgia" developed by the Department of Health of the Generalitat de Catalunya and the Servei Català de Salut.

Sponsors & Collaborators

• Universitat de Lleida

  lead OTHER

Principal Investigators

• Carolina Climent Sanz, PhDc · Universitat de Lleida

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-15

Primary Completion

2024-06-30

Completion

2024-11-15

Countries

• Spain

Study Locations