Clinical trial NCT05993663: Effectiveness of an Intervention Based on Arts In Health in the Quality of Life of People With Fibromyalgia.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Arts in Health
Mindfulness
Visual Thinking Strategies
Revised Fibromyalgia Impact Questionnaire (FIQ-R)
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Agència de Salut Pública de Catalunya (ASPCAT)
name: Institut Català de la Salut
name: Servei de Museus i Protecció de Béns Mobles
name: Museu de l'Empordà
name: Adhoc Cultura
First posted: 2023-08-15
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Individuals diagnosed with fibromyalgia (M79.1) or diagnosed with fibromyalgia and chronic fatigue syndrome (T78.40 and M79.7)
2. Over 18 years old.
3. They agree to participate in the study and sign the informed consent.

Exclusion Criteria:

1. 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.
2. 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.
3. Having previously participated in the group education project for people with fibromyalgia in Figueres Health Care Center.
4. Users who present a language barrier that makes good communication impossible.

Primary outcomes:
measure: Functional capacity
timeFrame: The first and last days of the intervention and 6 months after intervention.
measure: Life quality
timeFrame: The first and last days of the intervention and 6 months after intervention.
Secondary outcomes:
measure: Anxiety
timeFrame: 1 month before the intervention, last intervention day and 6 months after intervention.
measure: Emotional well-being
timeFrame: 1 month before the intervention, last intervention day and 6 months after intervention.
measure: Depression
timeFrame: 1 month before the intervention, last intervention day and 6 months after intervention.
measure: Social support
timeFrame: 1 month before the intervention, last intervention day and 6 months after intervention.
measure: Drug consumption
timeFrame: During the 6 months before the intervention and the 6 months after the intervention.
measure: Health care professional appointments.
timeFrame: During the 6 months before the intervention, during the interventions and the 6 months after the intervention.
Other outcomes:
Locations:
city: Figueres
country: Spain
facility: ABS Figueres
state: Girona
Study officials:
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