Mindfulness-based rehabilitation in a university museum for women with fibromyalgia
Art as a Therapeutic Tool in the Rehabilitation of Patients With Fibromyalgia: the University Museum as a Setting for an Integrative Medicine Program - a Randomized Controlled Trial
This 8-week mindfulness and body-awareness program delivered in a university museum will test whether it lowers pain and improves quality of life for women with fibromyalgia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | G. d'Annunzio University Academic / other |
| Locations | 2 sites (Chieti, Abruzzo and 1 other locations) |
| Trial ID | NCT07048366 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial assigns women with fibromyalgia to an 8-week integrated rehabilitation program based on mindfulness and body-awareness techniques delivered at the University Museum of G. d'Annunzio University or to a control group. The intervention combines integrative medicine approaches with art-related activities in the museum environment to target pain, fatigue, sleep disturbance, and coping skills. Primary outcomes include changes in pain intensity (VAS) and measures of physical and mental quality of life, with additional assessments of coping ability and functional status. Eligible participants are women aged 18–60 meeting the 2016 fibromyalgia criteria with recent significant pain (VAS >5).
Who should consider this trial
Good fit: Ideal candidates are women aged 18–60 diagnosed with fibromyalgia by 2016 criteria who report significant pain (VAS >5) and have no other major medical, neurological, or psychiatric conditions that would affect participation.
Not a fit: Patients with other chronic or localized painful conditions, conditions that affect pain perception (such as diabetes), recent cancer, ongoing corticosteroid or analgesic use, severe spinal disease, pregnancy, breastfeeding, or those outside the age range or male are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, the program could provide a non-pharmacological option to reduce pain and improve physical and mental quality of life and coping in women with fibromyalgia.
How similar studies have performed: Previous mindfulness and body-awareness programs have shown modest benefits for pain and quality of life in fibromyalgia, but delivering such rehabilitation within a museum or art setting is novel and not widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female patients * Diagnosis of Fibromyalgia Syndrome according to 2016 criteria * Muscle pain Visual Analogue Scale (VAS) score greater than 5 in the last month * Age between 18 and 60 years * Absence of other chronic, widespread, or localized painful conditions * Absence of any other condition that might affect pain perception (e.g., diabetes) * Absence of neurological or psychiatric conditions that might affect study participation * Absence of current or past oncological diseases in the last 5 years * Absence of corticosteroid therapy in the last 30 days * Absence of NSAID (Non-Steroidal Anti-Inflammatory Drugs) and analgesic therapy in the last 4 days * Absence of pregnancy and breastfeeding for the entire duration of observation * Signed informed consent Exclusion Criteria: * Presence of severe scoliosis or kyphoscoliosis * Previous spinal surgeries or sequelae of vertebral fractures * Presence of lumbosciatalgia (sciatica-like pain in the lower back) at the time of the visit * Presence of osteoporosis * Presence of neurological or psychiatric conditions * Current therapy with corticosteroids and/or NSAIDs and/or analgesics * Pregnancy or breastfeeding
Where this trial is running
Chieti, Abruzzo and 1 other locations
- CARES - Centro per la Disabilità, la Riabilitazione e Medicina dello Sport - University Center — Chieti, Abruzzo, Italy (Recruiting)
- Museo Universitario UD'A — Chieti, Abruzzo, Italy (Recruiting)
Study contacts
- Principal investigator: Teresa Paolucci, Associate Professor, MD, PhD — University of Study "G. d'Annunzio" of Chieti-Pescara
- Study coordinator: Teresa Paolucci, Associate Professor, MD, PhD
- Email: teresa.paolucci@unich.it
- Phone: +39 3479338625
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.