Therapeutic Educational Intervention and Fibromyalgia: a Mixed Methods Research

NCT03686410 | Unknown

• 1 other identifier: ULeida
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Fibromyalgia; Therapeutic Patient Education; Educational Technology; Mixed Methods Research; Pain; Poor Sleep Quality

Outcome Measures

Primary Outcomes (1)

• Pain Intensity

  Visual Analogue Scale: It was developed in the second half of the seventies and is considered the most sensitive test for the measurement of pain intensity. It is a user-friendly tool which consists of a numerically graduated line from 0-100, with 0 "no pain" and 100 "unbearable pain". Based on the research of Dworkin et al. it is established that a decrease of between 10 and 20% of pain intensity as the minimum clinically important difference, a change of ≥30% as a moderate clinical difference and, finally, a reduction in pain intensity ≥ 50% reflects substantial changes.

  4 weeks

Secondary Outcomes (4)

• Sleep quality

  4 weeks

• Pain Catastrophizing

  4 weeks

• Dysfunctional Beliefs and Attitudes about Sleep

  4 weeks

• Health status and quality of life associated with fibromyalgia

  4 weeks

Study Arms (2)

1. Therapeutic Educational Intervention

EXPERIMENTAL

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.

Behavioral: Web-based Therapeutic Educational Intervention

2. Convetional Tretament

ACTIVE COMPARATOR

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.

Other: Conventional Treatment

Interventions

Web-based Therapeutic Educational Intervention BEHAVIORAL

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.

1. Therapeutic Educational Intervention

Conventional Treatment OTHER

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.

2. Convetional Tretament

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Fibromyalgia based on the 2016 criteria of the American College of Rheumatology
• Women in adulthood: between 18 and 65 years of age
• Understand and speak Spanish and/or Catalan
• Accept and sign the informed consent

You may not qualify if:

• Be receiving or having received interventions similar to this study

Sponsors & Collaborators

• Universitat de Lleida: lead

Study Sites (1)

Faculty of Nursing and Physiotherapy, University of Lleida

Lleida, 25198, Spain

RECRUITING

Related Publications (1)

• Climent-Sanz C, Gea-Sanchez M, Moreno-Casbas MT, Blanco-Blanco J, Garcia-Martinez E, Valenzuela-Pascual F. A web-based therapeutic patient education intervention for pain and sleep for women with fibromyalgia: A sequential exploratory mixed-methods research protocol. J Adv Nurs. 2020 Jun;76(6):1425-1435. doi: 10.1111/jan.14333. Epub 2020 Mar 8.

  PMID: 32068285 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Carolina Climent Sanz, PhDc

  Universitat de Lleida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolina Climent-Sanz, PhDc

CONTACT

(+34) 622253062; ccs2@dif.udl.cat

Francesc Valenzuela-Pascual, PhDc

CONTACT

(+34) 692864540; fvp1969@dif.udl.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: the participants and the study researchers will not know the group assigned to each subject. In fact, the evaluations will be carried out through the website.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pre-doctoral fellow

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: September 26, 2018
• Study Start: January 15, 2020
• Primary Completion: June 30, 2024
• Study Completion: November 15, 2024
• Last Updated: May 11, 2023

Record last verified: 2023-05

Locations

ES (1)