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
Studieoversikt
Status
Forhold
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
|
Aktiv komparator: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from Baseline in Pain Intensity on the Visual Analog Scale (VAS)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- FMmuseo-v1.4-2026
- 596 (Annen identifikator: C.Et.R.A.)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .