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Search / Trial 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

Launched by G. D'ANNUNZIO UNIVERSITY · Jun 24, 2025

Trial Information

Current as of July 22, 2025

Not yet recruiting

Keywords

Fibromyalgia Rehabilitation Integrative Medicine Art Therapy Museums

ClinConnect Summary

This study is looking at whether an 8-week program combining mindfulness (a way to focus on the present moment) and body awareness exercises can help women with fibromyalgia feel less pain and improve their overall quality of life. What makes this program special is that it takes place in a university museum, offering a unique and calming environment. Fibromyalgia is a long-lasting condition that causes widespread muscle pain, tiredness, and trouble sleeping, and this study wants to see if this creative approach can help women better manage these symptoms.

Women between 18 and 60 years old who have been diagnosed with fibromyalgia and experience moderate to severe muscle pain may be eligible to join. To participate, they should not have other serious health issues that affect pain or brain function, and they should not be pregnant or breastfeeding. If selected, participants will be randomly placed into two groups: one will take part in the mindfulness and body awareness program at the museum, while the other will not receive this intervention. The study will then compare how these groups feel in terms of pain levels, mental well-being, and ability to cope with fibromyalgia. This trial is not yet recruiting, but if you qualify and decide to join, you can expect a supportive and innovative way to explore managing your fibromyalgia symptoms.

Gender

FEMALE

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

About G. D'annunzio University

G. D'Annunzio University, located in Chieti-Pescara, Italy, is a prominent academic institution committed to advancing scientific research and innovation in the health sciences. With a strong emphasis on interdisciplinary collaboration, the university fosters an environment that encourages the development of novel therapeutic strategies and clinical applications. As a clinical trial sponsor, G. D'Annunzio University seeks to contribute to the improvement of patient outcomes through rigorous research methodologies, ethical standards, and a focus on translational medicine. Their dedication to education and research excellence positions them as a key player in the advancement of healthcare solutions.

Locations

Chieti, Abruzzo, Italy

Chieti, Abruzzo, Italy

Patients applied

0 patients applied

Trial Officials

Teresa Paolucci, Associate Professor, MD, PhD

Principal Investigator

University of Study "G. d'Annunzio" of Chieti-Pescara

Ruggero D'Anastasio, Full Professor

Study Director

University of Study "G. d'Annunzio" of Chieti-Pescara, Director of University Museum

Giannapia Affaitati, MD, PhD

Principal Investigator

University of Study "G. d'Annunzio" of Chieti-Pescara, Co-Principal Investigator

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported