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

Not Applicable

Not yet recruiting

• Conditions: Fibromyalgia; Chronic Pain; Musculoskeletal Pain

• Registration Number: NCT07048366
• Lead Sponsor: G. d'Annunzio University

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.

Detailed Description

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:

* Stimulate the brain's reward system, fostering positive emotions and reducing pain perception.

* Modulate cortical maps, potentially normalizing altered somatosensory processing observed in fibromyalgia.

* Provide a powerful distraction from chronic pain and discomfort, shifting focus towards aesthetic appreciation and inner experiences.

* Enhance emotional regulation and promote self-efficacy in managing symptoms.

* The museum itself acts as a "setting of care," providing a calming and inspiring atmosphere that can amplify the therapeutic effects of rehabilitation, reducing stress and promoting overall well-being.

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.

Study Timeline

• Study First Submitted: 2025-06-24
• Study First Submitted QC: 2025-06-24
• Status Verified: 2025-07
• Study First Posted: 2025-07-02
• Last Update Submitted: 2025-07-17
• Last Update Posted: 2025-07-18
• Study Start: 2025-09-01
• Primary Completion: 2026-01-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
Quality of Life Improvement	Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).	Improvement in the physical and mental dimensions of quality of life. Metric: SF-12 (Short Form-12 Health Survey) total score (0-100).
Life Satisfaction	Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).	Changes in overall satisfaction with life. Metric: Satisfaction with Life Scale (SWLS) score (5-35).
Emotional Regulation Strategies	Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).	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).
Fibromyalgia Impact on Daily Life	Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).	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	Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).	Changes in the overall severity of symptoms associated with fibromyalgia. Metric: Fibromyalgia Status Scale (FSS) scores (0-10 for each item).
Anxiety Levels	Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).	Changes in anxiety symptoms. Metric: Zung Self-Rating Anxiety Scale (SAS) score (20-80).
Positive and Negative Emotions	Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).	Changes in positive and negative affect. Metric: Positive and Negative Affect Schedule (PANAS) scores (10-50 per dimension).
Depressive Symptoms	Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).	Changes in depressive symptoms. Metric: Zung Self-Rating Depression Scale (SDS) score (20-80).
Emotional State	Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).	Evaluation of participants' emotional state. Metric: Delighted Terrible Face scale.

Trial Locations

Locations (2)

Centro Fibromialgia, Clinica Geriatrica, Dipartimento di Medicina e Scienze dell'Invecchiamento, Presidio Ospedaliero SS. Annunziata; 🇮🇹 Chieti, Abruzzo, Italy

Museo Universitario UD'A; 🇮🇹 Chieti, Abruzzo, Italy