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

F

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Status

Enrolling

Conditions

Fibromyalgia

Treatments

Behavioral: Arts in health group intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT05993663
23/133-P

Details and patient eligibility

About

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.

Full 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.

Enrollment

121 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

121 participants in 2 patient groups

Intervention group
Experimental group
Description:
Intervention groups that will receive 12 Arts in Health session. There will be four groups of 15 individuals for reaching the needed sample size.
Treatment:
Behavioral: Arts in health group intervention
Control group
No Intervention group
Description:
Control groups. Participants in these groups won't receive any group intervention, just regular health care.

Trial contacts and locations

1

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Central trial contact

Judit Ferragutcasas Butiña

Data sourced from clinicaltrials.gov

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