Mindfulness-based Rehabilitation in a University Museum Setting to Reduce Pain and Improve Quality of Life in Women With Fibromyalgia: a Randomized Controlled Trial
NCT ID: NCT07048366
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
44 participants
INTERVENTIONAL
2025-11-27
2026-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Museum-Based Integrated Rehabilitation Group
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.
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 Control Group
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
FEMALE
No
Sponsors
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G. d'Annunzio University
OTHER
Responsible Party
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Teresa Paolucci
Associate Professor, MD, PhD, Physical and Rehabilitation Medicine
Principal Investigators
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Teresa Paolucci, Associate Professor, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Study "G. d'Annunzio" of Chieti-Pescara
Ruggero D'Anastasio, Full Professor
Role: STUDY_DIRECTOR
University of Study "G. d'Annunzio" of Chieti-Pescara, Director of University Museum
Giannapia Affaitati, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Study "G. d'Annunzio" of Chieti-Pescara, Co-Principal Investigator
Locations
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CARES - Centro per la Disabilità, la Riabilitazione e Medicina dello Sport - University Center
Chieti, Abruzzo, Italy
Museo Universitario UD'A
Chieti, Abruzzo, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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401144/25
Identifier Type: -
Identifier Source: org_study_id