About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Integrated Rehabilitation Program at the University Museum
BehavioralThis 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
Other interventionParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
Pain Reduction
Reduction in musculoskeletal pain intensity, evaluated by Visual Analogue Scale (VAS) for musculoskeletal pain (0-10 cm score).
Secondary outcomes
Quality of Life Improvement
Improvement in the physical and mental dimensions of quality of life. Metric: SF-12 (Short Form-12 Health Survey) total score (0-100).
Fibromyalgia Impact on Daily Life
Changes in the impact of fibromyalgia on daily activities and overall functioning. Metric: Fibromyalgia Impact Questionnaire (FIQ) scores (ranging from 0 to approximately 100).
Global Symptom Severity
Changes in the overall severity of symptoms associated with fibromyalgia. Metric: Fibromyalgia Status Scale (FSS) scores (0-10 for each item).
Anxiety Levels
Changes in anxiety symptoms. Metric: Zung Self-Rating Anxiety Scale (SAS) score (20-80).
Sponsors and contacts
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