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

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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05993663
Enrollment
121
Registered
2023-08-15
Start date
2023-10-02
Completion date
2025-12-30
Last updated
2023-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Keywords

Fibromyalgia, Arts in Health, Mindfulness, Visual Thinking Strategies, Revised Fibromyalgia Impact Questionnaire (FIQ-R)

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.

Interventions

BEHAVIORALArts 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

Sponsors

Agència de Salut Pública de Catalunya (ASPCAT)
CollaboratorUNKNOWN
Institut Català de la Salut
CollaboratorOTHER
Servei de Museus i Protecció de Béns Mobles
CollaboratorUNKNOWN
Museu de l'Empordà
CollaboratorUNKNOWN
Adhoc Cultura
CollaboratorUNKNOWN
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Masking description

No masking

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Functional capacityThe first and last days of the intervention and 6 months after intervention.Functional capacity with respect to pain management, measured with the Revised Fibromyalgia Impact Questionnaire (FIQ-R)
Life qualityThe first and last days of the intervention and 6 months after intervention.Quality of life perceived by the participants, measured with the EUROQOL

Secondary

MeasureTime frameDescription
Depression1 month before the intervention, last intervention day and 6 months after intervention.Depression
Social support1 month before the intervention, last intervention day and 6 months after intervention.Assessment of perceived social support with the Oslo Social Support Scale (OSLO-3) scale
Anxiety1 month before the intervention, last intervention day and 6 months after intervention.Assessment of anxiety with the Goldberg scale
Health care professional appointments.During the 6 months before the intervention, during the interventions and the 6 months after the intervention.Assistance to health services
Drug consumptionDuring the 6 months before the intervention and the 6 months after the intervention.Painkillers and psychotropic drugs consumed
Emotional well-being1 month before the intervention, last intervention day and 6 months after intervention.Assessment of emotional well-being with the Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS)

Countries

Spain

Contacts

Primary ContactJudit Ferragutcasas Butiña
jferragutcasa.girona.ics@gencat.cat600234302

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026