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Therapeutic Educational Intervention and Fibromyalgia: a Mixed Methods Research

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ClinicalTrials.gov Identifier: NCT03686410
Recruitment Status : Not yet recruiting
First Posted : September 26, 2018
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Carolina Climent-Sanz, Universitat de Lleida

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Behavioral: Web-based Therapeutic Educational Intervention Other: Conventional Treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Effects of a Web-based Therapeutic Educational Intervention About Pain and Poor Sleep Quality in Women Diagnosed With Fibromyalgia: a Mixed Methods Research With Sequential Exploratory Design
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: 1. 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.

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.


Active Comparator: 2. Convetional Tretament
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
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.




Primary Outcome Measures :
  1. Pain Intensity [ Time Frame: 4 weeks ]
    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.


Secondary Outcome Measures :
  1. Sleep quality [ Time Frame: 4 weeks ]
    Pittsburgh Sleep Quality Index: designed by Buysse et al., it is a self-administered questionnaire that evaluates the quality and alterations of sleep in a one-month interval. Through nineteen individual items, scored from 0 "no difficulty" to 3 "severe difficulty", seven sleep components are assessed: 1) subjective quality of sleep, 2) sleep latency, 3) sleep duration, 4) efficiency usual sleep, 5) sleep disturbances, 6) use of medication for sleep and 7) daily functionality. The overall score can vary from 0 to 21 points, 0 indicating no difficulty and 21 severe difficulties in all areas. The Spanish version was validated in a sample of people diagnosed with FM showing a Cronbach's alpha coefficient of 0.805 and Spearman's correlation coefficient of 0.0773 (p <0.001) for the total score demonstrating a good internal consistency and an acceptable test-retest realiability.

  2. Pain Catastrophizing [ Time Frame: 4 weeks ]

    Pain Catastrophizing Scale: It is a self-administered questionnaire developed by Sullivan et al. in 1995 with the objective of measuring the impact of catastrophic thoughts on the experience of pain. The Pain Catastrophizing Scale comprises three dimensions of pain catastrophizing: 1) rumination 2) magnification and 3) helplessness which are assessed in 13 items.

    The Spanish version was validated in people diagnosed with FM by García-Campayo et al. with a sample of 230 participants in 2008. The results showed that the scale presented the same factorial structure of the three dimensions and showed adequate psychometric properties, with a Cronbach's alpha coefficient of 0.79 and an intraclass ratio of 0.84.

    A reduction of the 15-30% is established as the minimum clinically significant change, changes between 30 and 50% are moderately clinically significant and reductions of ≥50% are indicative of substantial clinical improvement.


  3. Dysfunctional Beliefs and Attitudes about Sleep [ Time Frame: 4 weeks ]
    Dysfunctional Beliefs and Attitudes about Sleep Scale: The original full version was created by Morin in 1994 to evaluate dysfunctional thoughts that cause and / or maintain insomnia. It consists of 30 items that are grouped into five theoretical dimensions: 1) consequences of insomnia on the state of mind, greeting or daily activity, 2) Concerns about loss of control and prediction of sleep, 3) Unrealistic expectations about the need for sleep, 4) Causal attributions of insomnia and 5) Beliefs about habits or behaviors that favor sleep.

  4. Health status and quality of life associated with fibromyalgia [ Time Frame: 4 weeks ]

    The Revised Fibromyalgia Impact Questionnaire (FIQ-R): developed by Bennet et al. in 2009 and validated into Spanish by Salgueiro et al. in 2013. This is the most current version of the Fibromyalgia Impact Questionnaire that was created and validated in 1991 by Burkhardt, Clark & Bennet. The FIQ-R is a self-administered questionnaire consisting of 21 items that are analog visual scales with eleven boxes that establish a score from 0 to 10.

    The maximum total score of the questionnaire is 100 and results from the sum of the scores of the three parameters described, representing the total impact of the symptoms on the quality of life.

    The minimum clinically significant change for the FIQ-R is a total score change of 27.04 point or a 45.5% change.




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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Be receiving or having received interventions similar to this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03686410


Contacts
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Contact: Carolina Climent-Sanz, PhDc (+34) 622253062 ccs2@dif.udl.cat
Contact: Francesc Valenzuela-Pascual, PhDc (+34) 692864540 fvp1969@dif.udl.cat

Sponsors and Collaborators
Universitat de Lleida
Investigators
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Principal Investigator: Carolina Climent Sanz, PhDc Universitat de Lleida
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Carolina Climent-Sanz, Pre-doctoral fellow, Universitat de Lleida
ClinicalTrials.gov Identifier: NCT03686410    
Other Study ID Numbers: ULeida
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carolina Climent-Sanz, Universitat de Lleida:
Fibromyalgia
Therapeutic Patient Education
Educational Technology
Mixed Methods Research
Pain
Poor Sleep Quality
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases