- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06702839
Effect of BETY on Biopsychosocial States Associated With Chronic Pain in Rheumatic Individuals.
Investigation of the Effects of BETY on Biopsychosocial Status, Functionality, Mood and Quality of Life of Individuals Diagnosed With Rheumatism and Related to Chronic Pain: A Retrospective Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cognitive Exercise Therapy Approach (BETY) is an innovative exercise approach developed through the participation of rheumatic individuals in exercise sessions for many years. The main purpose of BETY is to transfer the patient's negative cognitions about their disease to a positive cognition level through functional gains through exercise. Thus, cognitive restructuring will be achieved.
In order to correctly organize the optimum treatment, rheumatic patients need to be evaluated biopsychosocially. Individual-centered scales that evaluate the disease process are currently considered at least as much as objective tests in determining treatment effectiveness and are increasingly used in clinical practice. Due to the multidimensional structure of chronic diseases, there is a need for measurement tools that evaluate individuals in a biopsychosocial context. BETY-Biopsychosocial Scale (BETY-BQ) was developed for this purpose with the feedback of the recovery characteristics of rheumatic individuals who participated in BETY sessions over the years.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Samanpazar
-
Ankara, Samanpazar, Turkey (Türkiye), 06100
- Hacettepe University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients who were diagnosed as Ankylosing spondylitis (1984 modified New York criteria, RA (2010 ACR/EULAR criteria), PsA (2006 CASPAR criteria), SLE (2012 Systemic Lupus International Collaborating Clinics criteria), SSc (2013 ACR/EULAR criteria), pSS (American-European Consensus Group criteria), OA (1986 ACR criteria) and FMS (2016 ACR criteria)
Exclusion Criteria:
- Patients who had severe cognitive problems
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cognitive Exercise Therapy Approach (Bilişsel Egzersiz Terapi Yaklaşımı-BETY)
3 days a week for 3 months
|
Individuals with rheumatism were included in BETY sessions after the first session, which included functional gain with function-focused trunk stabilization exercises for their complaints and chronic pain management training based on neuroscience. BETY sessions included function-focused trunk stabilization exercises, chronic pain management, mood information management (dance therapy - authentic movement) as innovative. Individuals were included in a separate session of sexual information management and sleep education. 3 days a week for 3 months |
|
Active Comparator: Home exercise program
For 3 months
|
Exercises have been shown and a brochure has been given The individuals in this group were mostly individuals from out of town who were given home exercise recommendations directed by a rheumatologist.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BETY-Biopsychosocial Questionnaire (BETY-BQ):
Time Frame: 3 months
|
it is a 30-item Likert-type scale developed through repeated statistics of feedback from rheumatic individuals who have participated in exercise sessions for many years, expressing the healing characteristics.
It evaluates the individual from a biopsychosocial perspective with the subheadings of pain, functionality-fatigue, mood, sociability, sexuality and sleep.
It is scored between 0 and 120.
BETY-BQ evaluates the individual from a holistic perspective with six subheadings: pain (5 items), functionality (9 items), mood (10 items), sociability (3 items), sexuality (2 items) and sleep (1 item).
A high score indicates a low biopsychosocial status.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health Assessment Questionnaire (HAQ)
Time Frame: 3 months
|
It is a scale developed to question functional inadequacy in daily living activities.
The scale questions a total of 8 activities, including dressing, sitting up, eating, walking, hygiene, reaching out, grasping and daily tasks, and consists of 20 questions.
Each question is scored between 0 and 3. High scores indicate a decrease in the individual's functionality.
|
3 months
|
|
Hospital Anxiety Depression Scale (HADS)
Time Frame: 3 months
|
It is a scale consisting of 14 questions (7 questions about depression, 7 questions about anxiety) that the individual is asked to answer by thinking about the last few days, and is scored between 0 and 3.
The cut-off values of the scale are 10 for the anxiety subscale and 7 for the depression subscale.
High total scores indicate high levels of anxiety or depression
|
3 months
|
|
Short Form - 36 (SF-36)
Time Frame: 3 months
|
SF-36, which is widely used in assessing quality of life, is a scale consisting of 8 sub-parameters: physical function (FF), social function (SF), role limitations due to physical problems, role limitations due to emotional problems, pain, energy level-vitality, mental health and general health perception.
Each sub-parameter is scored between 0 and 100.
High scores indicate good health status (35).
|
3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nur Banu Karaca, MSc. PT., Hacettepe University
- Study Director: Sedat Kiraz, Prof. Dr., Hacettepe University
- Principal Investigator: Aykut Ozçadırcı, Hacettepe University
- Principal Investigator: Orkun Tüfekçi, MSc. PT., Hacettepe University
- Principal Investigator: Aysima Barlak, Hacettepe University
- Study Director: Ali Akdoğan, Prof. Dr., Hacettepe University
- Study Chair: Edibe Unal, Prof. Dr., Hacettepe University
- Principal Investigator: Sevim Oksüz, PhD. PT., Eastern Mediterranean University
- Study Director: Şule Apraş Bilgen, Prof. Dr., Hacettepe University
- Study Director: Robert D. Gerwin, MD., Johns Hopkins University
- Study Director: Rinnie Geenen, Prof. Dr., Utrecht University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SBA 23/196
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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