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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorG. d'Annunzio University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Museum-Based Integrated Rehabilitation GroupExperimental treatment 1 intervention
Group B: CARES Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Secondary outcomes

1

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).
2

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).
3

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).
4

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).

Other outcomes

Sponsors and contacts

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