Back to results

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

Primary Purpose

Fibromyalgia

Status

Recruiting

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Arts in health group intervention

About this trial

This is an interventional supportive care trial for Fibromyalgia focused on measuring Fibromyalgia, Arts in Health, Mindfulness, Visual Thinking Strategies, Revised Fibromyalgia Impact Questionnaire (FIQ-R)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

ABS FigueresRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm 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.

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

Outcomes

Primary Outcome Measures

Functional capacity

Functional capacity with respect to pain management, measured with the Revised Fibromyalgia Impact Questionnaire (FIQ-R)

Life quality

Quality of life perceived by the participants, measured with the EUROQOL

Secondary Outcome Measures

Anxiety

Assessment of anxiety with the Goldberg scale

Emotional well-being

Assessment of emotional well-being with the Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS)

Depression

Social support

Assessment of perceived social support with the Oslo Social Support Scale (OSLO-3) scale

Drug consumption

Painkillers and psychotropic drugs consumed

Health care professional appointments.

Assistance to health services

Full Information

NCT ID

NCT05993663

First Posted

July 31, 2023

Last Updated

August 8, 2023

Sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05993663

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 2, 2023 (Anticipated)

Primary Completion Date

August 15, 2025 (Anticipated)

Study Completion Date

December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia

Keywords

Fibromyalgia, Arts in Health, Mindfulness, Visual Thinking Strategies, Revised Fibromyalgia Impact Questionnaire (FIQ-R)

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

Allocation

Randomized

Enrollment

121 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention group

Arm Type

Experimental

Arm 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.

Arm Title

Control group

Arm Type

No Intervention

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Arts in health group intervention

Intervention Description

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

Primary Outcome Measure Information:

Title

Functional capacity

Description

Functional capacity with respect to pain management, measured with the Revised Fibromyalgia Impact Questionnaire (FIQ-R)

Time Frame

The first and last days of the intervention and 6 months after intervention.

Title

Life quality

Description

Quality of life perceived by the participants, measured with the EUROQOL

Time Frame

The first and last days of the intervention and 6 months after intervention.

Secondary Outcome Measure Information:

Title

Anxiety

Description

Assessment of anxiety with the Goldberg scale

Time Frame

1 month before the intervention, last intervention day and 6 months after intervention.

Title

Emotional well-being

Description

Assessment of emotional well-being with the Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS)

Time Frame

1 month before the intervention, last intervention day and 6 months after intervention.

Title

Depression

Description

Depression

Time Frame

1 month before the intervention, last intervention day and 6 months after intervention.

Title

Social support

Description

Assessment of perceived social support with the Oslo Social Support Scale (OSLO-3) scale

Time Frame

1 month before the intervention, last intervention day and 6 months after intervention.

Title

Drug consumption

Description

Painkillers and psychotropic drugs consumed

Time Frame

During the 6 months before the intervention and the 6 months after the intervention.

Title

Health care professional appointments.

Description

Assistance to health services

Time Frame

During the 6 months before the intervention, during the interventions and the 6 months after the intervention.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Judit Ferragutcasas Butiña

Phone

600234302

jferragutcasa.girona.ics@gencat.cat

Facility Information:

Facility Name

ABS Figueres

City

Figueres

State/Province

Girona

ZIP/Postal Code

17600

Country

Spain

Individual Site Status

Recruiting

Facility Contact: