Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
FEMALE
NCT07048366

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

Led by G. d'Annunzio University · Updated on 2026-04-28

44

Participants Needed

2

Research Sites

35 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 60Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

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

Chieti, Abruzzo, Italy, 66100

Actively Recruiting

2

Museo Universitario UD'A

Chieti, Abruzzo, Italy, 66100

Actively Recruiting

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Research Team

T

Teresa Paolucci, Associate Professor, MD, PhD

CONTACT

A

Alice Cichelli, Bachelor's Degree

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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