Mindfulness-based Rehabilitation in a University Museum Setting to Reduce Pain and Improve Quality of Life in Women With Fibromyalgia: a Randomized Controlled Trial

NCT07048366 · tracked via the Priya Life Science Italy tracker

Sponsor

G. d'Annunzio University

Phase

Not applicable

Started

2025-11-27

Last updated

2026-04-28

Condition(s) studied

FibromyalgiaChronic PainMusculoskeletal Pain

Investigational drug(s) / intervention(s)

Integrated Rehabilitation Program at the University MuseumCARES treatment

Integrated Rehabilitation Program at the University Museum: This intervention consists of an 8-week integrated rehabilitation program, with weekly 60-minute sessions, conducted at the University Museum. The program includes mindfulness techniques, conscious breathing exercises, body scan meditation, mindfulness walking within the museum's exhibition spaces, specific stretching and mobilization techniques, and gratitude and recognition exercises, all framed by the artistic and cultural context of the museum. The museum environment is utilized as a therapeutic setting to amplify the benefits of the behavioral techniques.

CARES treatment: Participants in the control arm will receive the same mindfulness-based integrated rehabilitation program delivered at the CARES University Center. The intervention consists of eight weekly 60-minute sessions including breathing awareness, body scan, mindful walking, and guided mindfulness exercises. This program mirrors the structure and duration of the museum-based intervention but takes place in a conventional rehabilitation setting.

Study 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

Sex

FEMALE

Min age

18 Years

Max age

60 Years

Healthy volunteers

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

Primary outcome measure(s)

Pain Reduction — Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).
Reduction in musculoskeletal pain intensity, evaluated by Visual Analogue Scale (VAS) for musculoskeletal pain (0-10 cm score).

Trial sites (2)

Facility	City	Region	Status
CARES - Centro per la Disabilità, la Riabilitazione e Medicina dello Sport - University Center	Chieti	Abruzzo	Recruiting
Museo Universitario UD'A	Chieti	Abruzzo	Recruiting

More G. d'Annunzio University trials in Italy

Predictive Role of the Full-mouth Plaque Score on the Outcomes of Non-surgical Periodontal Therapy. Starting soon

Biofeedback Based System to Enhance Robotic Assisted Gait Training in Children With Cerebral Palsy Recruiting

Two Previous Cesarean and Vaginal Birth Before and After Starting Training and Protocols Recruiting

Optimizing Clinical Outcomes in CAF + SCTG: the Impact of Compressive Sutures Starting soon

Learning Curves of Different Devices for Vaginal Birth on Mannequin Enrolling by invitation

Other trials for the same condition

Neuro-modulation of Central Pain Pathways in Non Inflammatory Musculoskeletal Pain Syndrome Enrolling by invitation

MobACT: An Internet-Based Intervention for Chronic Pain Patients Recruiting

Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator Recruiting

Persistent Pain in Pharmacologically or Surgical Treated Osteoarthritis: Role of Mu-Limpho Marker Recruiting

Virtual Reality Rehabilitation in Neck Pain Subjects Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07048366 on ClinicalTrials.gov ↗ ← All trials in Italy