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

Fibromyalgia Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05993663
• Other study ID #: 23/133-P
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: July 2023
• Source: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Contact: Judit Ferragutcasas Butiña
• Phone: 600234302
• Email: jferragutcasa.girona.ics[@]gencat.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 121
• Est. completion date: December 30, 2025
• Est. primary completion date: August 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Spain	ABS Figueres	Figueres	Girona

Sponsors (6)

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

Country where clinical trial is conducted

Spain, 

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* Note: There are 48 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Anxiety	Assessment of anxiety with the Goldberg scale	1 month before the intervention, last intervention day and 6 months after intervention.
Secondary	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.
Secondary	Depression	Depression	1 month before the intervention, last intervention day and 6 months after intervention.
Secondary	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.
Secondary	Drug consumption	Painkillers and psychotropic drugs consumed	During the 6 months before the intervention and the 6 months after the intervention.
Secondary	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.