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

Sponsor
G. d'Annunzio University
Study ID
NCT07048366
Status
Recruiting
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Conditions

  • Chronic Pain
  • Fibromyalgia
  • Musculoskeletal Pain

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Jul 2, 2025
Start date
Nov 27, 2025
Status verified
Apr 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Pain Reduction [ Time Frame: Baseline (T0), End of treatment (T1, after 8 weeks), Follow-up (T2, 4 weeks after end of treatment). ]

Central Contacts

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