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The Effectiveness Of BETY In Fibromyalgia

Investigation The Effectiveness Of Cognitive Exercise Therapy Approach (Bilişsel Egzersiz Terapi Yaklaşımı - BETY) In Individuals With Fibromyalgia

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07034417
Enrollment
40
Registered
2025-06-24
Start date
2025-07-12
Completion date
2027-02-12
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Keywords

biopsychosocial model, pain, functional capacity, depression, anxiety, quality of life

Brief summary

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.

Interventions

OTHERExercise

Cognitive Exercise Therapy Approach

OTHERHome exercise

Home exercise

Sponsors

Alanya Alaaddin Keykubat University
CollaboratorOTHER
Alanya Alaaddin Keykubat University Alanya Training and Research Hospital
CollaboratorUNKNOWN
Aysima Barlak
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

Cognitive Exercise Therapy Approach (Bilişsel Egzersiz Terapi Yaklaşımı - BETY)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Being diagnosed with fibromyalgia * 18 years of age or older * Being literate * Having read and signed the informed consent * Not exercising regularly in the last 3 months

Exclusion criteria

* Having a malignant disease * Pregnancy * Having chronic infectious or other rheumatologic diseases * Having undergone a surgical operation in the last 6 months * Collagen tissue disease * History of peripheral vascular disease or neuropathy * Presence of diseases that cannot be controlled and prevent exercise

Design outcomes

Primary

MeasureTime frameDescription
Cognitive Exercise Therapy Approach (BETY)- Biopsychosocial Questionnaire3 mounthsThe 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.

Secondary

MeasureTime frameDescription
Health Asessement Questionnaire (HAQ)3 mounthsIt 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.
Short Form - 363 mounthsSF-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.
Pain Catastrophizing Scale3 mounthsThis 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.
Fatigue Severity Scale3 mounthsIt is a scale that evaluates fatigue and consists of 9 questions. Each item is scored between 0 and 7. The total score is divided by 9 and a mean score of \<4 indicates no fatigue and a mean score of ≥4 indicates fatigue.
Tampa Scale of Kinesiophobia3 mounthsThis scale is a 17-question scale developed to measure fear of movement/reinjury.The scale includes parameters of injury/re-injury and fear-avoidance in work-related activities
Hospital Anxiety Depression Scale (HADS)3 mounthsAlthough 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.
Brief Illness Perception Questionnaire3 mounthsThe other 7 items in the scale have a Likert-type scoring scale from 0 to 10. The scale consists of two sub-dimensions (cognitive and emotional). The eighth item consists of an open-ended question. Individuals are asked to answer open-ended questions about the three most important reasons for the illness. A high score indicates that the illness is threatening and a low score indicates that the person is comfortable.
McGill Pain Questionnaire Short Form3 mounthsDeveloped by Melzack in 1987 and the validity and reliability of the Turkish version has been demonstrated, the questionnaire is widely used to measure pain. This questionnaire consists of a total of 15 descriptive words to determine the sensory (11 words) and effective (4 words) characteristics of pain. In this section, pain intensity (0=absent, 1=mild, 2=moderate, 3=severe) is assessed to arrive at three pain scores (sensory, effective and total pain ratio = sensory + effective). In addition, the pain felt at the time of the measurement is calculated with the Visual Analog Scale (VAS) and the total pain intensity is calculated with a 6-point Likert scale. In this scale, 0: no pain, 1: mild, 2: uncomfortable, 3: distressing, 4: terrible, 5: unbearable pain.
Central Sensitization Scale3 mounthsThe Central Sensitization Scale consists of 2 parts, parts A and B. Symptoms associated with central sensitization in section A is questioned. These symptoms include sensitivity to smell, light, chemical stimuli, headache, full body pain, neck and shoulder tension, muscle stiffness and pain, skin itching/redness, depressive features, waking up restless, restless legs before sleep, sleep disturbance, low energy, anxiety attacks, impaired concentration, memory problems, worsening of symptoms with stress, frequent urge to urinate, bladder discomfort, diarrhea/constipation problems and pelvic pain. Section A contains 25 items with a total score range of 0-100. For each item in this section, one of the following responses is given: never (0 points), rarely (1 point), sometimes (2 points), often (3 points), always (4 points). A score of 40 and above indicates the presence of central sensitization. In section B, it is questioned whether the patient has been diagnosed with another.
Time Up and Go Test3 mounthsThe balance status of the individual is evaluated by getting up from a chair with back support, walking 3 meters at a normal walking speed and returning back to the chair and the time he/she sits on the chair is measured and recorded in seconds.The test is repeated 3 times.
6 min Walk Test3 mounthsIt will be used to assess the functional capacity of the patients. Patients will be asked to walk as long as possible in a 20-meter hospital corridor for 6 minutes in their own rhythm and with standard commands and the distance walked will be recorded in meters.
Fibromyalgia Impact Questionnaire3 mounthsIt is used to evaluate the health status and physical functionality of the individual diagnosed with fibromyalgia. It is a 10-question scale that assesses physical function, work status, productivity level, depression, anxiety, sleep, pain, stiffness, fatigue and well-being.

Countries

Turkey (Türkiye)

Contacts

Primary ContactKübra Sargın Baskın, PT, MSc
kubrasbaskin@hotmail.com5335664516

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026