Clinical trial NCT06702839: Effect of BETY on Biopsychosocial States Associated With Chronic Pain in Rheumatic Individuals.
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatic Diseases
Keywords: biopsychosocial
holistic
exercise
functioning
sleep
chronic pain
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
Collaborators: name: Hacettepe University
First posted: 2024-11-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: No study has been found in the literature investigating the effectiveness of an innovative exercise approach defined on a biopsychosocial basis and having its own original scale on individuals with rheumatism over the years. The aim of this retrospective study was to determine the effects of the Cognitive Exercise Therapy Approach on the biopsychosocial conditions related to chronic pain; functionality, mood and quality of life of individuals with rheumatism diagnosis and to examine the effectiveness of BETY as a routine exercise approach by presenting the results compared with the control group.

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.

Eligibility criteria: 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

Primary outcomes:
measure: BETY-Biopsychosocial Questionnaire (BETY-BQ):
timeFrame: 3 months
Secondary outcomes:
measure: Health Assessment Questionnaire (HAQ)
timeFrame: 3 months
measure: Hospital Anxiety Depression Scale (HADS)
timeFrame: 3 months
measure: Short Form - 36 (SF-36)
timeFrame: 3 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Samanpazar
Study officials:
affiliation: Hacettepe University
name: Aykut Ozçadırcı
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Nur Banu Karaca, MSc. PT.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Orkun Tüfekçi, MSc. PT.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Aysima Barlak
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Fatma Birgül Kumbaroğlu
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Sinan Buran, MSc. PT.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Ali Akdoğan, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Sedat Kiraz, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Edibe Unal, Prof. Dr.
role: STUDY_CHAIR
affiliation: Eastern Mediterranean University
name: Sevim Oksüz, PhD. PT.
role: PRINCIPAL_INVESTIGATOR
References: