The Effectiveness Of BETY In Fibromyalgia

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: Home exercise; Other: Exercise

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kübra Sargın Baskın, PT, MSc; Phone Number: 5335664516; Email: kubrasbaskin@hotmail.com

Study Locations

• Turkey
  • Alanya
    • Antalya, Alanya, Turkey, 07425
      • Alanya Alaaddin Keykubat University
      • Contact: Kübra Sargın Baskın, PT, MSc; Phone Number: 5335664516; Email: kubrasbaskin@hotmail.com
      • Principal Investigator: Edibe Ünal, PT, PhD, Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BETY Group; BETY exercise sessions	Other: Exercise; Cognitive Exercise Therapy Approach
Other: Control Group; Home exercise program	Other: Home exercise; Home exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 mounths

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 mounths
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.	3 mounths
Tampa Scale of Kinesiophobia	This 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	3 mounths
Time Up and Go Test	The 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.	3 mounths
6 min Walk Test	It 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.	3 mounths
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.	3 mounths
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.	3 mounths
Fatigue Severity Scale	It 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.	3 mounths
Fibromyalgia Impact Questionnaire	It 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.	3 mounths
Brief Illness Perception Questionnaire	The 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.	3 mounths
McGill Pain Questionnaire Short Form	Developed 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.	3 mounths
Central Sensitization Scale	The 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.	3 mounths

Collaborators and Investigators

• Sponsor: Aysima Barlak
• Collaborators: Alanya Alaaddin Keykubat University; Alanya Alaaddin Keykubat University Alanya Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 12, 2025
• Primary Completion (Estimated): August 30, 2025
• Study Completion (Estimated): February 12, 2027

Study Registration Dates

• First Submitted: March 18, 2025
• First Submitted That Met QC Criteria: June 23, 2025
• First Posted (Actual): June 24, 2025

Study Record Updates

• Last Update Posted (Actual): June 24, 2025
• Last Update Submitted That Met QC Criteria: June 23, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: pain; quality of life; depression; anxiety; functional capacity; biopsychosocial model
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 03-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No