Clinical trial NCT06186830: Cognitive Exercise Therapy Approach Biopsychosocial Questionnaire (BETY-BQ) in Patient with Temporomandibular Disorders
Official title: Validity, Reliability and Responsiveness of the Cognitive Exercise Therapy Approach Biopsychosocial Questionnaire in Individuals with Temporomandibular Disorder
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Temporomandibular Disorder
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Keywords: validity
reliability
responsiveness
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: Karabuk University
First posted: 2024-01-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with temporomandibular disorder

Brief summary: The aim of this study is to investigate the validity, reliability, and responsiveness of the Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire (BETY-BQ) in individuals with temporomandibular disorder. The following are alternative hypotheses of the study:

* BETY-BQ has significant convergence with the Patient Health Questionnaire-9 measuring depression.
* BETY-BQ has significant convergence with the Patient Health Questionnaire-15 measuring physical symptoms.
* BETY-BQ has significant convergence with the Generalized Anxiety Disorder-7 measuring anxiety.
* BETY-BQ has significant convergence with the Short Form-36 measuring quality of life.
* BETY-BQ has significant convergence with the Craniomandibular Pain and Disability Inventory measuring disability.
* BETY-BQ has significant convergence with the Mandibular Function Impairment Questionnaire measuring function.
* BETY-BQ has significant stability.
* BETY-BQ has significant internal consistency.

Detailed description: Patient Health Questionnaire-9 (Depression), Patient Health Questionnaire-15 (Physical Symptoms), Generalized Anxiety Disorder-7 (Anxiety), Short Form-36 (Quality of Life), Craniomandibular Pain and Disability Inventory (Disability), and Mandibular Function Impairment Questionnaire (Function) will be administered to participants. For reliability analysis, test-retest stability evaluations will be repeated with the same questionnaire on 30 individuals with a 2-week interval. To determine responsiveness, the same questionnaire will be reapplied to the same 30 individuals at 3-month intervals.

Eligibility criteria: Inclusion Criteria:

* Having received a diagnosis of temporomandibular disorder

Exclusion Criteria:

* Experiencing difficulty in cooperating to fill out the questionnaires
* Being unwilling to participate in the study

Primary outcomes:
measure: Validity of BETY-BQ in measuring depression
timeFrame: Baseline
measure: Validity of BETY-BQ in measuring physical symptoms
timeFrame: Baseline
measure: Validity of BETY-BQ in measuring anxiety
timeFrame: Baseline
measure: Validity of BETY-BQ in measuring quality of life
timeFrame: Baseline
measure: Validity of BETY-BQ in measuring disability
timeFrame: Baseline
measure: Validity of BETY-BQ in measuring function
timeFrame: Baseline
measure: Test-retest stability of BETY-BQ
timeFrame: From baseline to 2nd week
measure: Internal consistency of BETY-BQ
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
city: Karabük
country: Turkey
facility: Karabük University
Study officials:
affiliation: Karabük University
name: Harun Gençosmanoğlu, PT, MSc
role: PRINCIPAL_INVESTIGATOR
References: