NCT06830213

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

Not yet recruiting Last updated 19 February 2025

What this trial tests

trial testing Questionnaire study in Familial Mediterranean Fever (FMF ) in 100 participants. Not yet recruiting.

Timeline

18 February 2025

Primary endpoint
30 March 2027

30 December 2027

Quick facts

Lead sponsor	Aysima Barlak
Status	Not yet recruiting
Study type	OBSERVATIONAL
Enrollment	100
Start date	18 February 2025
Primary completion	30 March 2027
Estimated completion	30 December 2027
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Questionnaire study

Conditions studied

• Familial Mediterranean Fever (FMF ) — all drugs for Familial Mediterranean Fever (FMF ) →

Sponsor

Aysima Barlak

Who can join

18 and older, any sex, with Familial Mediterranean Fever (FMF ). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.