An interventional study of Museum-Based Mindfulness & Body Awareness Program and Gym-Based Mindfulness & Body Awareness Program in Fibromyalgia, sponsored by G. d'Annunzio University. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by G. d'Annunzio University · Not applicable, Interventional, and Treatment
This randomized controlled trial investigates the efficacy of a mindfulness-based rehabilitation program delivered in a non-traditional environment rich in art and beauty (the University Museum, UD'A) compared to a traditional university gym setting (CARES) for patients with fibromyalgia.
The main question the study aims to answer is whether conducting mindfulness sessions in a museum setting can better reduce muscle pain (primary objective) and improve body awareness and quality of life (secondary objectives) compared to a standard gym setting. Additionally, the study evaluates autonomic nervous system responses using non-invasive thermal infrared imaging.
Furthermore, this protocol incorporates an exploratory home-based maintenance component-utilizing an illustrated educational brochure and a preregistered video of previously learned exercises-during a four-week follow-up period (T1-T2) to assess adherence, feasibility, and the maintenance of therapeutic benefits
1,375 studies on the registry are indexed under Fibromyalgia; 275 are open to participants now.
This study's planned enrollment of 44 is below the median of 60 across 1,060 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →G. d'Annunzio University is the lead sponsor of 66 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants assigned to this arm receive an 8-week mindfulness and body awareness exercise program (2 sessions per week, 60 minutes each) conducted in a non-traditional setting rich in art and beauty (University Museum, UdA). This is followed by a 4-week home-based maintenance period using an illustrated educational brochure and guided exercise videos.
Behavioral: Museum-Based Mindfulness & Body Awareness Program
Participants assigned to this arm receive the exact same 8-week mindfulness and body awareness exercise program (2 sessions per week, 60 minutes each) delivered in a standard university gym setting (CARES center). This is followed by the same 4-week home-based maintenance period using an illustrated educational brochure and guided exercise videos.
Behavioral: Gym-Based Mindfulness & Body Awareness Program
An 8-week structured group program (2 sessions/week, 60 minutes each) combining mindfulness techniques, body awareness practices, and gentle postural exercises, conducted inside the University Museum (UdA). Includes an additional 4-week home maintenance phase with educational brochures and instructional videos.
An 8-week structured group program (2 sessions/week, 60 minutes each) combining mindfulness techniques, body awareness practices, and gentle postural exercises, conducted in a traditional university gym setting (CARES). Includes an additional 4-week home maintenance phase with educational brochures and instructional videos.
Change from Baseline in Pain Intensity on the Visual Analog Scale (VAS)
Time frame: Baseline (T0), post-intervention at 8 weeks (T1), and follow-up at 12 weeks (T2)
Change from Baseline in Fibromyalgia Impact Questionnaire (FIQ) Total Score
Total score of the Fibromyalgia Impact Questionnaire (FIQ) assessing overall fibromyalgia disease severity and functional impact across three domains: function, overall impact, and symptoms. Total score ranges from 0 to 100, where higher scores reflect greater symptom severity and impact on daily life.
Time frame: Baseline (T0), Post-intervention at 8 weeks (T1), and Follow-up at 12 weeks (T2)
Adherence to Home-Based Exercise Maintenance Program
Adherence to the home-based maintenance program (guided by educational brochure and preregistered videos) measured as the percentage of completed prescribed exercise sessions recorded via a self-reported daily exercise log during the 4-week follow-up period. Adherence is calculated as (Number of completed sessions / Total prescribed sessions) \* 100.
Time frame: Daily during the 4-week follow-up period (from Week 8 to Week 12)
No study locations are listed for this record.
Start is estimated for Dec 2026; primary completion for Dec 2027, 12 months later.
Of 515 non-industry interventional studies with no phase under Fibromyalgia, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 27. This study's planned 12 months is close to that.
Counting every sponsor, half of 527 studies reached it within 13 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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G. d'Annunzio University