Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06186830
Other study ID # 2023/1361
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 17, 2023
Est. completion date June 2024

Study information

Verified date December 2023
Source Hacettepe University
Contact Harun Gençosmanoglu, PT, MSc
Phone +903704189093
Email harungencosmanoglu@karabuk.edu.tr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date June 2024
Est. primary completion date February 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 64 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Validity and reliability analyses
Validity and reliability analyses will be performed using Cognitive Exercise Therapy Approach Biopsychosocial Questionnaire, Patient Health Questionnaire-9, Patient Health Questionnaire-15, Generalized Anxiety Disorder-7, Short Form-36, Craniomandibular Pain and Disability Inventory, and Mandibular Function Impairment Questionnaire.

Locations

Country Name City State
Turkey Hacettepe University Ankara
Turkey Karabük University Karabük

Sponsors (2)

Lead Sponsor Collaborator
Hacettepe University Karabuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Validity of BETY-BQ in measuring depression Patient Health Questionnaire-9. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome. Baseline
Primary Validity of BETY-BQ in measuring physical symptoms Patient Health Questionnaire-15. Minimum and maximum values are 0 and 2 points, respectively. Higher scores mean a worse outcome. Baseline
Primary Validity of BETY-BQ in measuring anxiety Generalized Anxiety Disorder-7. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome. Baseline
Primary Validity of BETY-BQ in measuring quality of life Short Form-36. It is a 36-item valid and reliable evaluation with eight areas covering physical functioning, role limitations brought on by physical issues, bodily pain, general health perceptions, vitality, social functioning, role limitations brought on by emotional issues, and perceived mental health. The SF-36 also contains a single question called "health transition" that measures how respondents feel their over health status has changed over the course of a year. Baseline
Primary Validity of BETY-BQ in measuring disability Craniomandibular Pain and Disability Inventory. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome. Baseline
Primary Validity of BETY-BQ in measuring function Mandibular Function Impairment Questionnaire. Minimum and maximum values are 0 and 4 points, respectively. Higher scores mean a worse outcome. Baseline
Primary Test-retest stability of BETY-BQ The Cognitive Exercise Therapy Approach Biopsychosocial Questionnaire will be repeated on 30 individuals with a 2-week interval. From baseline to 2nd week
Primary Responsiveness of BETY-BQ The Cognitive Exercise Therapy Approach Biopsychosocial Questionnaire will be repeated on same 30 individuals at 3-month intervals. From baseline to 3rd month
Primary Internal consistency of BETY-BQ Cognitive Exercise Therapy Approach Biopsychosocial Questionnaire. Minimum and maximum values are 0 and 4 points, respectively. Higher scores mean a worse outcome. Baseline
See also
  Status Clinical Trial Phase
Recruiting NCT05006963 - Tele-Rehabilitation in Patients With Temporomandibular Dysfunction N/A
Completed NCT04102306 - Assessing Motor Imagery Ability of Tongue and Mouth in Subjects With and With no Temporomandibular Disorders
Not yet recruiting NCT05297604 - Non-Invasive Intravascular Laser Irradiation Of Blood In The Treatment Of Children With Temporomandibular Disorders Phase 2
Recruiting NCT03849534 - Treatment of Temporomandibular Disorders in Children and Adolsecents N/A
Recruiting NCT06035341 - The Association Between Temporomandibular Disorders and Sacroiliac Joint Dysfunction N/A
Not yet recruiting NCT05021874 - The Effect of Different Physiotherapeutic Stimuli on Stomatognathic System Structures. N/A
Recruiting NCT05232604 - How is Aerobic Exercise Compared to Localized Pain Relief Exercises in Patients With Jaw Pain and Neck Pain? N/A
Completed NCT04557878 - Role of Liquid Phase Concentrated Growth Factors vs. Hypertonic Dextrose Prolotherapy for Management of Patients With Disc Displacement Without Reduction Phase 2
Completed NCT03726060 - Effectiveness of Physical Teraphy in the Treatment of Myogenic Temporomandibular Disorders N/A
Not yet recruiting NCT06123351 - Forward Head Posture Correction Impact on Temporomandibular Dysfunction N/A
Completed NCT03619889 - The Effectiveness of a Physiotherapy Technique in Patients With Chronic Myofascial Temporomandibular Disorder N/A
Completed NCT01000389 - A Clinical Trial of the Optimal Treatment Period and Long-term Efficacy of Functional Electrical Stimulation (FES) on Sleep Bruxism N/A
Completed NCT00743223 - The Frequency Forward Head Posture in Subjects With Temporomandibular Disorder N/A
Completed NCT03300297 - Cervical Spine Thrust Joint Manipulation for Temporomandibular Disorder N/A
Completed NCT06065826 - Forward Head Posture and Myogenic TMD Association in Smartphone Overuse
Completed NCT04087005 - Efficacy and Safety of JHG002 for Chronic Temporomandibular Joint Dysfunction: A Multicenter Randomized Controlled Trial N/A
Recruiting NCT03696706 - Photobiomodulation With Red and Infrared LED Device for Temporomandibular Dysfunction Phase 2
Completed NCT04041271 - Jaw Kinematics and Muscle Activation in Patients With Non-specific Chronic Neck Pain
Recruiting NCT03096301 - Photobiomodulation in Temporomandibular Disorder N/A
Not yet recruiting NCT06052722 - The Relationship of Premenstrual Syndrome and Primary Dysmenorrhea With Severity of Temporomandibular Disorders N/A