NCT07048366 Mindfulness-based Rehabilitation in a University Museum Setting to Reduce Pain and Improve Quality of Life in Women With Fibromyalgia: a Randomized Controlled Trial
| NCT ID | NCT07048366 |
| Status | Recruiting |
| Phase | — |
| Sponsor | G. d'Annunzio University |
| Condition | Fibromyalgia |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2025-11-27 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 44 participants in total. It began in 2025-11-27 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This research study aims to investigate whether art and integrative medicine, within a unique setting like a university museum, can offer a new approach to help women suffering from fibromyalgia. Fibromyalgia is a chronic condition causing widespread pain and other symptoms such as fatigue and sleep disturbances. The question this study seeks to answer is: Is an 8-week rehabilitation program, based on mindfulness and body awareness techniques, conducted at the University Museum of the G. d'Annunzio University, effective in reducing pain and improving the quality of life (physical and mental well-being) and coping abilities in female fibromyalgia patients? Participants will be randomly assigned to either receive this program in the museum or to a control group.
Eligibility 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
Contact & Investigator
Teresa Paolucci, Associate Professor, MD, PhD
PRINCIPAL INVESTIGATOR
University of Study "G. d'Annunzio" of Chieti-Pescara
Frequently Asked Questions
Who can join the NCT07048366 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 60 Years, studying Fibromyalgia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07048366 currently recruiting?
Yes, NCT07048366 is actively recruiting participants. Contact the research team at teresa.paolucci@unich.it for enrollment information.
Where is the NCT07048366 trial being conducted?
This trial is being conducted at Chieti, Italy, Chieti, Italy.
Who is sponsoring the NCT07048366 clinical trial?
NCT07048366 is sponsored by G. d'Annunzio University. The principal investigator is Teresa Paolucci, Associate Professor, MD, PhD at University of Study "G. d'Annunzio" of Chieti-Pescara. The trial plans to enroll 44 participants.
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