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

Sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina (Other)

Overall Status

Recruiting

CT.gov ID

NCT05993663

Collaborator

Agència de Salut Pública de Catalunya (ASPCAT) (Other), Institut Català de la Salut (Other), Servei de Museus i Protecció de Béns Mobles (Other), Museu de l'Empordà (Other), Adhoc Cultura (Other)

121

Enrollment

Location

Arms

26.9

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia	Behavioral: Arts in health group intervention	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

121 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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 totalSingle intervention will be carried out for the 60 people who are part of the intervention groups, which will be 4 in total

Masking:

None (Open Label)

Masking Description:

No masking

Primary Purpose:

Supportive Care

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.

Anticipated Study Start Date :

Oct 2, 2023

Anticipated Primary Completion Date :

Aug 15, 2025

Anticipated Study Completion Date :

Dec 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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
No Intervention: Control group Control groups. Participants in these groups won't receive any group intervention, just regular health care.

Arm

Intervention/Treatment

Experimental: 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.

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

No Intervention: Control group

Control groups. Participants in these groups won't receive any group intervention, just regular health care.

Outcome Measures

Primary Outcome Measures

Functional capacity [The 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 quality [The first and last days of the intervention and 6 months after intervention.]
Quality of life perceived by the participants, measured with the EUROQOL

Secondary Outcome Measures

Anxiety [1 month before the intervention, last intervention day and 6 months after intervention.]
Assessment of anxiety with the Goldberg scale
Emotional well-being [1 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)
Depression [1 month before the intervention, last intervention day and 6 months after intervention.]
Depression
Social support [1 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
Drug consumption [During the 6 months before the intervention and the 6 months after the intervention.]
Painkillers and psychotropic drugs consumed
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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