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

August 8, 2023 updated by: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

121

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Girona
      • Figueres, Girona, Spain, 17600
        • Recruiting
        • ABS Figueres
        • Contact:
        • Principal Investigator:
          • Judit Ferragutcasas Butiñà, physician
        • Principal Investigator:
          • Xavier López Blánquez, psychologist
        • Principal Investigator:
          • Clàudia Molina-Martínez, psychologist
        • Sub-Investigator:
          • Agustina Cros Peñalba, nurse
        • Sub-Investigator:
          • Marta Roura Fausellas, nurse
        • Sub-Investigator:
          • Eloisa Gómez Garcia, nurse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional capacity
Time Frame: 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)
The first and last days of the intervention and 6 months after intervention.
Life quality
Time Frame: The first and last days of the intervention and 6 months after intervention.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: 1 month before the intervention, last intervention day and 6 months after intervention.
Assessment of anxiety with the Goldberg scale
1 month before the intervention, last intervention day and 6 months after intervention.
Emotional well-being
Time Frame: 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)
1 month before the intervention, last intervention day and 6 months after intervention.
Depression
Time Frame: 1 month before the intervention, last intervention day and 6 months after intervention.
Depression
1 month before the intervention, last intervention day and 6 months after intervention.
Social support
Time Frame: 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
1 month before the intervention, last intervention day and 6 months after intervention.
Drug consumption
Time Frame: During the 6 months before the intervention and the 6 months after the intervention.
Painkillers and psychotropic drugs consumed
During the 6 months before the intervention and the 6 months after the intervention.
Health care professional appointments.
Time Frame: During the 6 months before the intervention, during the interventions and the 6 months after the intervention.
Assistance to health services
During the 6 months before the intervention, during the interventions and the 6 months after the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 2, 2023

Primary Completion (Estimated)

August 15, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

July 31, 2023

First Submitted That Met QC Criteria

August 8, 2023

First Posted (Actual)

August 15, 2023

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 8, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23/133-P

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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