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Clinical Trials in Turkey / NCT06830213
Starting soon Observational

Investigation of the Validity, Reliability and Responsiveness of the BETY-BQ in FMF

NCT06830213 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2025-02-18
Last updated
2025-02-19

Condition(s) studied

Familial Mediterranean Fever (FMF )

Investigational drug(s) / intervention(s)

Questionnaire study

Questionnaire study: Questionnaire application

Study summary

FMF is associated with many different clinical entities. The disease appears to be associated with many diseases and/or syndromes with common features of genetic predisposition, immune dysfunction and autoinflammation. Pericardial inflammation, cardiovascular conditions such as ischaemic heart disease, other rheumatic diseases such as ankylosing spondylitis (AS), vasculitis, especially Behçet's disease, malignancy and infertility are often associated with FMF. Early detection of these associations makes it possible to improve the management and prognosis of patients with FMF.

The chronic nature of the disease, as in other chronic diseases, includes problems such as pain, fatigue, sleep problems, loss of function, anxiety, depression and social isolation. This complex structure is accompanied by a picture in which inflammatory processes are triggered.

When the literature is examined, it is emphasised that chronic diseases with multifaceted symptoms require evaluation and methods that include all these biopsychosocial features. On the other hand, although it is stated that the common goal of non-pharmacological treatments is to contribute to biopsychosocial improvement in the patient, it is emphasised that evaluations with biopsychosocial content are insufficient. This situation causes the need for scales that provide an assessment from a holistic perspective in chronic diseases.

Cognitive Exercise Therapy Approach (BETY) is an innovative exercise approach developed on the basis of biopsychosocial model on individuals with rheumatism. The parameters that constitute the innovation are detailed under four headings: function-oriented core stabilisation exercises, information management in pain, information management in mood, and information management in sexuality. This method has a unique scale that offers biopsychosocial assessment. The Cognitive Exercise Therapy Approach - Biopsychosocial Questionnaire (BETY-BQ) was created by receiving feedback from individuals with rheumatism who participated in BETY exercise training 3 days a week for many years, expressing the improvement characteristics they experienced by participating in exercise sessions. The BETY-BQ evaluates the individual biopsychosocially with six sub-headings: pain, functionality-fatigue, emotion-state, sociability, sexuality and sleep.

The validity, reliability and sensitivity of the BETY-BQ have been demonstrated in many rheumatic diseases such as rheumatoid arthritis, fibromyalgia, psoriatic arthritis, systemic lupus erythematosus, ankylosing spondylitis, knee osteoarthritis, primary Sjögren's syndrome. Currently, it is clear that there is a need for scales that offer biopsychosocial assessment for individuals diagnosed with rheumatism, where biopsychosocial approaches are recommended in EULAR recommendations. BETY-BQ is included in the EULAR library as a biopsychosocial status measurement tool. This study will investigate the validity, reliability and responsiveness of the BETY-BQ, a biopsychosocial assessment tool, in individuals diagnosed with Familial Mediterranean Fever.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Having a diagnosis of Familial Mediterranean Fever * Being literate * Being 18 years of age or older * Having read and signed the informed consent Exclusion Criteria: * History of major psychiatric illness * Malignant disease * History of peripheral vascular disease or neuropathy * Not volunteering for the study

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hacettepe University Ankara Altındağ

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06830213 on ClinicalTrials.gov ↗ ← All trials in Turkey