Effectiveness of an Intervention Based on Arts In Health in the Quality of Life of People With Fibromyalgia.
NCT ID: NCT05993663
Last Updated: 2023-08-15
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
121 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-10-02
Study Completion Date
2025-12-30
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.
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.
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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.
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.
Conditions
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Fibromyalgia
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Single intervention will be carried out for the 60 people who are part of the intervention groups, which will be 4 in total
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
NONE
No masking
Study Groups
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Intervention group
Intervention groups that will receive 12 Arts in Health session. There will be four groups of 15 individuals for reaching the needed sample size.
Group Type
EXPERIMENTAL
Arts in health group intervention
Intervention Type
BEHAVIORAL
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
Control group
Control groups. Participants in these groups won't receive any group intervention, just regular health care.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Arts in health group intervention
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
Intervention Type
BEHAVIORAL
Eligibility Criteria
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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.
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.
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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Agència de Salut Pública de Catalunya (ASPCAT)
UNKNOWN
Sponsor Role
collaborator
Institut Català de la Salut
OTHER
Sponsor Role
collaborator
Servei de Museus i Protecció de Béns Mobles
UNKNOWN
Sponsor Role
collaborator
Museu de l'Empordà
UNKNOWN
Sponsor Role
collaborator
Adhoc Cultura
UNKNOWN
Sponsor Role
collaborator
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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ABS Figueres
Figueres, Girona, Spain
Site Status
RECRUITING
Countries
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Spain
Central Contacts
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Facility Contacts
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References
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Other Identifiers
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23/133-P
Identifier Type: -
Identifier Source: org_study_id
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