An interventional study of Integrated Rehabilitation Program at the University Museum and CARES treatment in Fibromyalgia, Chronic Pain and Musculoskeletal Pain, sponsored by G. d'Annunzio University. Recruiting at 2 sites in Italy. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by G. d'Annunzio University · Not applicable, Interventional, and Treatment
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.
Fibromyalgia Syndrome (FM) is a complex and debilitating chronic musculoskeletal pain condition characterized by widespread pain, tenderness, and a myriad of associated symptoms including profound fatigue, sleep disturbances, cognitive impairment (often referred to as "fibro-fog"), and affective disorders such as anxiety and depression. Its prevalence is significant, affecting a substantial portion of the global population, predominantly women. Diagnosis relies on established criteria (e.g., ACR 1990, revised 2010/2011, and 2016 criteria), emphasizing the presence of widespread pain and symptom severity. The underlying pathophysiology is multifactorial, involving neuro-immuno-endocrine dysregulation, central sensitization (an amplification of pain signals in the central nervous system), and in some cases, small fiber neuropathy, leading to an altered pain perception.
Given its complex nature, a purely pharmacological approach to fibromyalgia is often insufficient. Current evidence strongly supports a multifactorial therapeutic strategy that integrates pharmacological treatments with non-pharmacological interventions, including complementary therapies and integrated medicine. This study introduces a novel, non-pharmacological integrated rehabilitation pathway designed to address the multifaceted symptoms of fibromyalgia.
This randomized controlled trial investigates the efficacy of a unique integrated rehabilitation program delivered within the evocative environment of a university museum. The program leverages the principles of art therapy and neuroaesthetics, combined with established mindfulness and body awareness techniques, to create a holistic and immersive healing experience. The rationale is rooted in the understanding that engagement with art and culturally enriching environments can positively influence brain function and emotional states. Specifically, interactions within a museum setting are hypothesized to:
The intervention consists of an 8-week program with weekly 60-minute sessions. Participants in the experimental group engage in a structured curriculum that integrates various techniques, including 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 university museum. This approach aims to cultivate body awareness, reduce pain catastrophizing, and improve emotional coping mechanisms.
Participants with a confirmed diagnosis of fibromyalgia will be randomly assigned (1:1 ratio) to either this museum-based integrated therapy group or a control group (e.g., a waitlist for conventional treatments). The study is designed to rigorously evaluate the impact of this innovative approach on primary and secondary outcome measures, including pain reduction, improvement in quality of life, and enhanced coping strategies. Ethical considerations, including informed consent and participant safety, are paramount, and the study adheres to the principles of the Declaration of Helsinki. The sample size has been determined through a power calculation to ensure statistical validity, aiming to detect a clinically significant reduction in pain as the primary outcome.
This study seeks to provide robust evidence for the therapeutic potential of art and integrated medicine in the management of fibromyalgia, potentially offering a valuable, accessible, and non-pharmacological addition to existing treatment paradigms.
Exclusion Criteria:
Participants in this arm will receive an 8-week integrated rehabilitation program conducted at the University Museum. The program consists of weekly 60-minute sessions that incorporate 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.
Behavioral: Integrated Rehabilitation Program at the University Museum
Participants in this arm will receive the same mindfulness-based integrated rehabilitation program delivered at the CARES (Center for Disability, Rehabilitation and Sports Medicine), at University. This group will serve as the control arm for comparison with the experimental museum-based intervention.
Other: CARES treatment
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.
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.
Pain Reduction
Reduction in musculoskeletal pain intensity, evaluated by Visual Analogue Scale (VAS) for musculoskeletal pain (0-10 cm score).
Time frame: Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).
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).
Time frame: Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).
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).
Time frame: Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).
Global Symptom Severity
Changes in the overall severity of symptoms associated with fibromyalgia. Metric: Fibromyalgia Status Scale (FSS) scores (0-10 for each item).
Time frame: Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).
Anxiety Levels
Changes in anxiety symptoms. Metric: Zung Self-Rating Anxiety Scale (SAS) score (20-80).
Time frame: Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).
Depressive Symptoms
Changes in depressive symptoms. Metric: Zung Self-Rating Depression Scale (SDS) score (20-80).
Time frame: Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).
Emotional State
Evaluation of participants' emotional state. Metric: Delighted Terrible Face scale.
Time frame: Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).
Life Satisfaction
Changes in overall satisfaction with life. Metric: Satisfaction with Life Scale (SWLS) score (5-35).
Time frame: Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).
Positive and Negative Emotions
Changes in positive and negative affect. Metric: Positive and Negative Affect Schedule (PANAS) scores (10-50 per dimension).
Time frame: Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).
Emotional Regulation Strategies
Changes in emotional regulation processes, specifically reappraisal and suppression. Metric: Emotional Regulation Questionnaire (ERQ) scores (typical range: 6-42 for Reappraisal, 4-28 for Suppression).
Time frame: Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).
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