The Effectiveness Of BETY In Fibromyalgia

ConditionFibromyalgia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAysima Barlak

About this trial

Fibromyalgia Syndrome (FMS) is a nonarticular, chronic rheumatic disorder of unknown etiology characterized by widespread musculoskeletal pain, impaired sleep quality, fatigue and the presence of identified tender points. Pain, the main symptom of the disease, is described as chronic and widespread. It is reported that the pain usually starts in the neck and shoulders but becomes widespread by being felt in various parts of the body during the day. Although it is difficult to localize the pain, it is reported to be localized to the paracervical and trapezius muscle and paralumbar and gluteal body parts.

Cognitive Exercise Therapy Approach is an innovative exercise approach developed on the basis of biopsychosocial model on individuals with rheumatism. This method has a unique scale that offers biopsychosocial assessment. There is the Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire (BETY-BQ). Validity, reliability and sensitivity studies of BETY-BQ have been conducted in individuals with fibromyalgia. This study aims to examine the effect of BETY, an exercise approach developed on the basis of the biopsychosocial model, on individuals with fibromyalgia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Being diagnosed with fibromyalgia

18 years of age or older

Being literate

Having read and signed the informed consent

Disqualifiers

Having a malignant disease

Pregnancy

Having chronic infectious or other rheumatologic diseases

Having undergone a surgical operation in the last 6 months

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exercise

    Other intervention

    Cognitive Exercise Therapy Approach

  • Home exercise

    Other intervention

    Home exercise

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: BETY GroupExperimental treatment 1 intervention
Group B: Control GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

Cognitive Exercise Therapy Approach (BETY)- Biopsychosocial Questionnaire

The BETY Questionnaire was developed on rheumatic patients and was introduced to the literature as a standardized biopsychosocial measurement tool as a result of improving the definitions of recovery from patients with expert opinions and statistical analysis. Scoring of the scale is done using a 5-point Likert system, each item is scored between 0 and 4 points, and a high total score in the scale consisting of a total of 30 items indicates a high biopsychosocial impact.

Time frame
3 mounths

Secondary outcomes

1

Hospital Anxiety Depression Scale (HADS)

Although the HADS was developed 20 years ago for the clinical measurement of anxiety and depression levels and was originally developed for hospitalized individuals, it now has a wide spectrum of use and can be used in many situations, including healthy people. Seven of the 14 items provide insight into the level of anxiety, while seven include questions about the level of depression. Each question is scored between 0 and 3, with a high score indicating high affectivity. Anxiety and depression sub-parameters are scored separately and 11 points and above are considered abnormal.

Time frame
3 mounths
2

Health Asessement Questionnaire (HAQ)

It is a scale developed in individuals with rheumatoid arthritis and can be used in a wide range of populations while assessing all rheumatic disease groups. It has 8 subheadings and consists of a total of 20 questions. Sub-headings include dressing, sitting and staying, eating, walking, hygiene, reaching, grasping and activities of daily living. Each answer is scored between 0 and 3 points and the higher the score, the more difficult the activity is.

Time frame
3 mounths
3

Short Form - 36

SF-36 scale will be used to determine the level of health status and quality of life of individuals.SF-36 is a patient-oriented assessment scale created in the United States of America that allows for general health screening.Each sub-parameter is scored between 0 and 100 points and a high score indicates good health status.The SF-36 scale has 8 sub-parameters including general health perception, physical function, social function, pain, mental health, role difficulties due to physical causes, role difficulties due to emotional causes and vitality and includes 11 questions with a total of 36 items.

Time frame
3 mounths
4

Pain Catastrophizing Scale

This scale, developed by Sullivan et al. (1995), measures the exaggerated negative mental reaction of individuals to current or anticipated painful experiences and the extent to which they catastrophize pain.The reliability and validity of the Turkish version of the scale was demonstrated by Uğurlu et al. (2017) and consists of 13 items.Each item is scored as never=0, slightly=1, moderately=2, greatly=3 and always=4.A high total score indicates a high degree of catastrophizing of pain.

Time frame
3 mounths

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aysima Barlak

Lead sponsor

Hacettepe University

Sponsor institution

Alanya Alaaddin Keykubat University

Collaborator

Alanya Alaaddin Keykubat University Alanya Training and Research Hospital

Collaborator

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