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 | Recruiting

• 1 other identifier: 401144/25
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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.

Conditions

Fibromyalgia; Chronic Pain; Musculoskeletal Pain

Keywords

Fibromyalgia; Rehabilitation; Integrative Medicine; Art Therapy; Museums

Outcome Measures

Primary Outcomes (1)

• Pain Reduction

  Reduction in musculoskeletal pain intensity, evaluated by Visual Analogue Scale (VAS) for musculoskeletal pain (0-10 cm score).

  Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).

Secondary Outcomes (9)

• Quality of Life Improvement

  Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).

• Fibromyalgia Impact on Daily Life

  Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).

• Global Symptom Severity

  Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).

• Anxiety Levels

  Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).

• Depressive Symptoms

  Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment).

Study Arms (2)

Museum-Based Integrated Rehabilitation Group

EXPERIMENTAL

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

CARES Control Group

ACTIVE COMPARATOR

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

Interventions

Integrated Rehabilitation Program at the University Museum BEHAVIORAL

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.

Museum-Based Integrated Rehabilitation Group

CARES treatment OTHER

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.

CARES Control Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Only female participants with a diagnosis of Fibromyalgia Syndrome are eligible to participate.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• G. d'Annunzio University: lead

Study Sites (2)

CARES - Centro per la Disabilità, la Riabilitazione e Medicina dello Sport - University Center

Chieti, Abruzzo, 66100, Italy

RECRUITING

Museo Universitario UD'A

Chieti, Abruzzo, 66100, Italy

RECRUITING

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain; Musculoskeletal Pain

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Teresa Paolucci, Associate Professor, MD, PhD

  University of Study "G. d'Annunzio" of Chieti-Pescara

  PRINCIPAL INVESTIGATOR

• Ruggero D'Anastasio, Full Professor

  University of Study "G. d'Annunzio" of Chieti-Pescara, Director of University Museum

  STUDY DIRECTOR

• Giannapia Affaitati, MD, PhD

  University of Study "G. d'Annunzio" of Chieti-Pescara, Co-Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Teresa Paolucci, Associate Professor, MD, PhD

CONTACT

+39 3479338625; teresa.paolucci@unich.it

Alice Cichelli, Bachelor's Degree

CONTACT

+39 3278588219; alice.cichelli@unich.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This study employs a double-blind design where both participants and outcome assessors are masked to the intervention assignment. Participants are unaware of their group allocation (treatment vs. control). Personnel collecting and analyzing outcome data will also be blinded to group assignment to minimize bias. The care providers delivering the intervention, due to the nature of the behavioral therapy, may not be fully masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD, PhD, Physical and Rehabilitation Medicine

Model Details: Participants with fibromyalgia will be randomly assigned in a 1:1 ratio to either the integrated rehabilitation program conducted in the museum setting or to a control group receiving the same mindfulness-based intervention at the CARES (Center for Disability, Rehabilitation and Sports Medicine), at University . Both groups will be followed in parallel for the study duration.

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 2, 2025
• Study Start: November 27, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)