Exploring how improvement perception affects fibromyalgia patients
The Effect of Perception of Improvement Provided Virtual Reality Environment on Symptom Presence and Severity in Patients With Fibromyalgia
NA · Istanbul Medeniyet University · NCT06508385
This study tests how feeling better affects women with fibromyalgia by looking at their brain activity during breathing exercises.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 39 (estimated) |
| Ages | 25 Years to 55 Years |
| Sex | Female |
| Sponsor | Istanbul Medeniyet University (other) |
| Locations | 1 site (Istanbul, Kartal) |
| Trial ID | NCT06508385 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of perceived improvement on patients diagnosed with fibromyalgia, a chronic pain condition characterized by altered pain processing. The approach involves assessing functional brain activity and tissue properties in response to breathing exercises. Participants will be women aged 25-55 who have had fibromyalgia for at least a year and meet specific pain intensity criteria. The study aims to understand how emotional and cognitive factors influence pain perception and management in fibromyalgia.
Who should consider this trial
Good fit: Ideal candidates are women aged 25-55 diagnosed with fibromyalgia for at least one year and experiencing significant pain.
Not a fit: Patients with inflammatory diseases, severe obesity, or those unable to participate in fMRI scans may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for fibromyalgia patients by addressing the psychological aspects of pain perception.
How similar studies have performed: While there is ongoing research into pain perception and management in fibromyalgia, this specific approach focusing on breathing exercises and brain activity is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Diagnosed with Fibromyalgia at least 1 year ago according to ACR criteria Age range 25-55 Female Scored at least 24 on the Mini-Mental State Assessment Test Reported weekly pain intensity of at least 40 mm on the Visual Analog Scale Be on a stable dose of medication for at least 6 months (serotonin norepinephrine reuptake inhibitors \[e.g., duloxetine, milnacipran\]; alpha 2-delta receptor ligand \[e.g., pregabalin\]; gabapentinoids) Exclusion Criteria: Having inflammatory rheumatic disease, malignancy, neurological disease, connective tissue disease, severe anemia, uncontrolled endocrine diseases Body Mass Index (BMI) ≥ 30 Kg/m2 Being pregnant Having inability to understand, read and speak Turkish Having difficulty in hearing and seeing Having any metallic or electronic device in the body that will create incompatibility with the magnetic field in the fMRI scan Having any disease diagnosis (serious psychotic disorder, delirium, mental retardation, epilepsy, heart disease, lung diseases, etc.) that may prevent participation in the evaluation and training to be conducted within the scope of the research
Where this trial is running
Istanbul, Kartal
- Nilüfer kablan — Istanbul, Kartal, Turkey (Türkiye) (RECRUITING)
Study contacts
- Principal investigator: Nilüfer Kablan, PhD — İstanbul Medeniyet Üniversitesi
- Study coordinator: nilüfer Kablan, PhD
- Email: niluferkablan@yahoo.com
- Phone: 05067638556
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fibromyalgia, functional brain activity, Pain, Tissue properties