Effectiveness of an Intervention Based on Arts In Health in the Quality of Life of People With Fibromyalgia.
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| ClinicalTrials.gov Identifier: NCT05993663 |
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Recruitment Status :
Recruiting
First Posted : August 15, 2023
Last Update Posted : August 15, 2023
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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 | Not Applicable |
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 (Clinical Trial) |
| Estimated 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 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. |
| Estimated Study Start Date : | October 2, 2023 |
| Estimated Primary Completion Date : | August 15, 2025 |
| Estimated Study Completion Date : | December 30, 2025 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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 |
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No Intervention: Control group
Control groups. Participants in these groups won't receive any group intervention, just regular health care.
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- 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)
- 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
- Anxiety [ Time Frame: 1 month before the intervention, last intervention day and 6 months after intervention. ]Assessment of anxiety with the Goldberg scale
- 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)
- Depression [ Time Frame: 1 month before the intervention, last intervention day and 6 months after intervention. ]Depression
- 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
- Drug consumption [ Time Frame: During the 6 months before the intervention and the 6 months after the intervention. ]Painkillers and psychotropic drugs consumed
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05993663
| Contact: Judit Ferragutcasas Butiña | 600234302 | jferragutcasa.girona.ics@gencat.cat |
| Spain | |
| ABS Figueres | Recruiting |
| Figueres, Girona, Spain, 17600 | |
| Contact: Maria Carrillo, Manager 972 67 76 31 eap_figueres.girona.ics@gencat.cat | |
| 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 | |
| Responsible Party: | Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina |
| ClinicalTrials.gov Identifier: | NCT05993663 |
| Other Study ID Numbers: |
23/133-P |
| First Posted: | August 15, 2023 Key Record Dates |
| Last Update Posted: | August 15, 2023 |
| Last Verified: | July 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Fibromyalgia Arts in Health Mindfulness Visual Thinking Strategies Revised Fibromyalgia Impact Questionnaire (FIQ-R) |
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Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases |
Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases |