Art and Mindfulness in Fibromyalgia Rehabilitation at the University Museum
L'Arte Come Strumento di Cura Nella Presa in Carico Riabilitativa Nel Paziente Con Fibromialgia: Museo Universitario Come Setting Del Percorso di Medicina Integrata - Studio Randomizzato Controllato
This randomized controlled trial investigates the efficacy of a mindfulness-based rehabilitation program delivered in a non-traditional environment rich in art and beauty (the University Museum, UD'A) compared to a traditional university gym setting (CARES) for patients with fibromyalgia.
The main question the study aims to answer is whether conducting mindfulness sessions in a museum setting can better reduce muscle pain (primary objective) and improve body awareness and quality of life (secondary objectives) compared to a standard gym setting. Additionally, the study evaluates autonomic nervous system responses using non-invasive thermal infrared imaging.
Furthermore, this protocol incorporates an exploratory home-based maintenance component-utilizing an illustrated educational brochure and a preregistered video of previously learned exercises-during a four-week follow-up period (T1-T2) to assess adherence, feasibility, and the maintenance of therapeutic benefits
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Written informed consent provided prior to study initiation.
- Confirmed diagnosis of Fibromyalgia Syndrome according to the ACR (American College of Rheumatology) criteria.
- Age between 18 and 60 years.
- Stable pharmacological treatment for fibromyalgia for at least 4 weeks prior to enrollment, with agreement not to modify dosage during the study unless strictly necessary.
- Ability to comprehend, speak, and read Italian to complete self-reported outcome measures and participate in group sessions.
- Ability to provide written consent and follow study procedures.
Exclusion Criteria:
- Severe cognitive impairment or active psychiatric disorders (e.g., severe clinical depression, psychosis, bipolar disorder) preventing participation in group sessions or self-report evaluations.
- Severe cardiovascular, respiratory, metabolic, or systemic diseases that contraindicate low-to-moderate physical activity.
- Concomitant autoimmune or inflammatory rheumatic diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis).
- Presence of severe neurological disorders (e.g., Parkinson's disease, multiple sclerosis, stroke sequelae).
- Regular participation in structured mindfulness, yoga, or body awareness programs within the last 6 months.
- Ongoing pregnancy or planned pregnancy during the study period.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Museum-Based Mindfulness Group
Participants assigned to this arm receive an 8-week mindfulness and body awareness exercise program (2 sessions per week, 60 minutes each) conducted in a non-traditional setting rich in art and beauty (University Museum, UdA). This is followed by a 4-week home-based maintenance period using an illustrated educational brochure and guided exercise videos. |
An 8-week structured group program (2 sessions/week, 60 minutes each) combining mindfulness techniques, body awareness practices, and gentle postural exercises, conducted inside the University Museum (UdA). Includes an additional 4-week home maintenance phase with educational brochures and instructional videos. |
|
Comparatore attivo: Gym-Based Mindfulness Group
Participants assigned to this arm receive the exact same 8-week mindfulness and body awareness exercise program (2 sessions per week, 60 minutes each) delivered in a standard university gym setting (CARES center). This is followed by the same 4-week home-based maintenance period using an illustrated educational brochure and guided exercise videos. |
An 8-week structured group program (2 sessions/week, 60 minutes each) combining mindfulness techniques, body awareness practices, and gentle postural exercises, conducted in a traditional university gym setting (CARES). Includes an additional 4-week home maintenance phase with educational brochures and instructional videos. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change from Baseline in Pain Intensity on the Visual Analog Scale (VAS)
Lasso di tempo: Baseline (T0), post-intervention at 8 weeks (T1), and follow-up at 12 weeks (T2)
|
Baseline (T0), post-intervention at 8 weeks (T1), and follow-up at 12 weeks (T2)
|
|
|
Change from Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score
Lasso di tempo: Baseline (T0), Post-intervention at 8 weeks (T1), and Follow-up at 12 weeks (T2)
|
Total score of the Fibromyalgia Impact Questionnaire (FIQ) assessing overall fibromyalgia disease severity and functional impact across three domains: function, overall impact, and symptoms. Total score ranges from 0 to 100, where higher scores reflect greater symptom severity and impact on daily life. |
Baseline (T0), Post-intervention at 8 weeks (T1), and Follow-up at 12 weeks (T2)
|
|
Adherence to Home-Based Exercise Maintenance Program
Lasso di tempo: Daily during the 4-week follow-up period (from Week 8 to Week 12)
|
Adherence to the home-based maintenance program (guided by educational brochure and preregistered videos) measured as the percentage of completed prescribed exercise sessions recorded via a self-reported daily exercise log during the 4-week follow-up period. Adherence is calculated as (Number of completed sessions / Total prescribed sessions) * 100. |
Daily during the 4-week follow-up period (from Week 8 to Week 12)
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- FMmuseo-v1.4-2026
- 596 (Altro identificatore: C.Et.R.A.)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .