Effectiveness of an Intervention Based on Arts In Health in the Quality of Life of People With Fibromyalgia.

Study Overview
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Brief Summary
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The aim of this intervention is to measure the impact of a 12-session intervention with Arts in Health methodology on the quality of life of the population with fibromyalgia. The main questions it aims to answer are: To know if the methodology of Arts in Health is effective for the improvement of the functional capacity of people with fibromyalgia Which are the most effective techniques within this intervention During the intervention, the participants will take part in mindfulness sessions, dance, visual thinking strategies, aimed at a greater understanding of the disease and the development of healthy habits. The results of this intervention are compared with a control group, in which the same scales and instruments will be passed in the same period of time. To complete the information gathering, a focus group will be held to obtain qualitative information about the experience of the participants.

Detailed Description
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Arts in Health is a methodology that seeks to use the power of arts and culture to improve people's health and well-being. To develop it, collaboration is promoted between health professionals and those in the artistic and cultural fields. In accordance with the Arts in Health strategy of the Catalan Health Institute, the primary health care professionals in Figueres have started a joint project along Museu de l'Empordà, a local museum, to address fibromyalgia from this perspective. The objectives are to quantitatively analyze the effectiveness of an Arts in Health intervention to improve the functional capacity with respect to pain and the quality of life of people with fibromyalgia. Also, qualitatively assess the experience of the participants and explore how they value the impact of cultural activities on health. Joint work has been carried out to produce a guide where, through different modalities of Art, the symptoms and needs of people suffering from fibromyalgia will be addressed. Affected people have also collaborated in this process. With the results of this work, the content of the Intervention has been designed. From here, a mixed methodology study is proposed through a randomized clinical trial for people affected by fibromyalgia. For the quantitative analysis, quality of life tests and a disability perception test due to pain, (FIQ-R), will be taken before, at the end and 6 months after the intervention. For the qualitative analysis, focus groups will be formed at the end of the intervention.

Official Title
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Museums as Health Spaces: Design and Evaluation of the Effectiveness of an Arts in Health Intervention to Improve the Quality of Life and Functional Capacity Regarding the Pain of People With Fibromyalgia. Mixed Methodology Study.

Conditions
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Fibromyalgia

Intervention / Treatment
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* Behavioral: Arts in health group intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals diagnosed with fibromyalgia (M79.1) or diagnosed with fibromyalgia and chronic fatigue syndrome (T78.40 and M79.7) Over 18 years old. They agree to participate in the study and sign the informed consent. Exclusion Criteria: Serious concomitant rheumatological pathology, that is to say, that this involves a much more important functional disability than that caused by the fibromyalgia pathology itself. Serious psychiatric pathology [according to V Diagnostical and Statical Manual of Mental Disorders (DSM-V) criteria] that could make it difficult to participate in the sessions and follow the study. Or that due to his psychiatric diagnosis, participation in a group was not advisable because of the negative impact it could cause. Having previously participated in the group education project for people with fibromyalgia in Figueres Health Care Center. Users who present a language barrier that makes good communication impossible.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single intervention will be carried out for the 60 people who are part of the intervention groups, which will be 4 in total
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Intervention groups that will receive 12 Arts in Health session. There will be four groups of 15 individuals for reaching the needed sample size. | Behavioral: Arts in health group intervention<br>* 12 sessions using the Arts in Health methodology with the aim of having a better understanding of the disease, developing healthy lifestyle habits and greater emotional intelligence. Visual thinking strategies, game based activities, mindfulness and dance will be used<br>|
| No Intervention: Control group<br>Control groups. Participants in these groups won't receive any group intervention, just regular health care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional capacity | Functional capacity with respect to pain management, measured with the Revised Fibromyalgia Impact Questionnaire (FIQ-R) | The first and last days of the intervention and 6 months after intervention. | 
| Life quality | Quality of life perceived by the participants, measured with the EUROQOL | The first and last days of the intervention and 6 months after intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | Assessment of anxiety with the Goldberg scale | 1 month before the intervention, last intervention day and 6 months after intervention. | 
| Emotional well-being | Assessment of emotional well-being with the Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) | 1 month before the intervention, last intervention day and 6 months after intervention. | 
| Depression | Depression | 1 month before the intervention, last intervention day and 6 months after intervention. | 
| Social support | Assessment of perceived social support with the Oslo Social Support Scale (OSLO-3) scale | 1 month before the intervention, last intervention day and 6 months after intervention. | 
| Drug consumption | Painkillers and psychotropic drugs consumed | During the 6 months before the intervention and the 6 months after the intervention. | 
| Health care professional appointments. | Assistance to health services | During the 6 months before the intervention, during the interventions and the 6 months after the intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibromyalgia, Arts in Health, Mindfulness, Visual Thinking Strategies, Revised Fibromyalgia Impact Questionnaire (FIQ-R)