Temporomandibular DisorderNCT06186830
Cognitive Exercise Therapy Approach Biopsychosocial Questionnaire (BETY-BQ) in Patient with Temporomandibular Disorders
An observational study of Temporomandibular Disorder and Temporomandibular Joint Disorders, run by Hacettepe University at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Temporomandibular Disorder, Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome
- What is being tested?
- Validity and reliability analyses
- How many people
- 150 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 17 Dec 2023to Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with temporomandibular disorder
Who may be able to join
- Having received a diagnosis of temporomandibular disorder
Who cannot join
- Experiencing difficulty in cooperating to fill out the questionnaires
- Being unwilling to participate in the study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Hacettepe University
Ankara, 06100
Harun Gençosmanoğlu, PT, MSc, +903704189093 ext. 9093, harun.gencosmanoglu@hacettepe.edu.tr
- Recruiting
Karabük University
Karabük, Karabük Province, 78050
Harun Gençosmanoğlu, PT, MSc, +903704189093 ext. 9093, harungencosmanoglu@karabuk.edu.tr
About this study
Official title: Validity, Reliability and Responsiveness of the Cognitive Exercise Therapy Approach Biopsychosocial Questionnaire in Individuals with Temporomandibular Disorder
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.
Read the 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.
- Conditions
- Temporomandibular Disorder, Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome
- Being tested
- Validity and reliability analyses
- Keywords
- validity, reliability, responsiveness
- Medical subject headings
- Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Validity and reliability analysesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with temporomandibular disorder | Not described Receives: Other: Validity and reliability analyses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
Test-retest stability of BETY-BQ
The Cognitive Exercise Therapy Approach Biopsychosocial Questionnaire will be repeated on 30 individuals with a 2-week interval.
Measured: From baseline to 2nd week
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start17 Dec 2023
- Primary completion15 Jul 2024
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisorderStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Karabuk University
- Responsible party
- Principal investigator, Harun Gençosmanoğlu, Karabuk University
- Investigators
- Harun Gençosmanoğlu, PT, MSc, Principal investigator, Karabük University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186830
- Sponsor's protocol ID
- 2023/1361
- Status last verified
- Mar 2025
- First submitted
- 17 Dec 2023
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity, Reliability and Responsiveness of the Cognitive Exercise Therapy Approach Biopsychosocial Questionnaire in Individuals with Temporomandibular Disorder
- ClinicalTrials.gov ID
- NCT06186830
- Acronym / sponsor ID
- 2023/1361
- Conditions
- Temporomandibular Disorder, Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome
- Keywords
- validity, reliability, responsiveness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Karabuk University
- Study start
- 17 Dec 2023 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- Aug 2025 (estimated)
- First posted
- 2 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with temporomandibular disorder | – | Other: Validity and reliability analyses |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with temporomandibular disorder
Key inclusion criteria (1 listed)
- Having received a diagnosis of temporomandibular disorder
Key exclusion criteria (2 listed)
- Experiencing difficulty in cooperating to fill out the questionnaires
- Being unwilling to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Validity and reliability analysesValidity 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. | Other | Patients with temporomandibular disorder |
Primary outcome
Validity of BETY-BQ in measuring depression
Time frame: Baseline
Patient Health Questionnaire-9. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.
Validity of BETY-BQ in measuring physical symptoms
Time frame: Baseline
Patient Health Questionnaire-15. Minimum and maximum values are 0 and 2 points, respectively. Higher scores mean a worse outcome.
Validity of BETY-BQ in measuring anxiety
Time frame: Baseline
Generalized Anxiety Disorder-7. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.
Validity of BETY-BQ in measuring quality of life
Time frame: Baseline
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.
Validity of BETY-BQ in measuring disability
Time frame: Baseline
Craniomandibular Pain and Disability Inventory. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.
Validity of BETY-BQ in measuring function
Time frame: Baseline
Mandibular Function Impairment Questionnaire. Minimum and maximum values are 0 and 4 points, respectively. Higher scores mean a worse outcome.
Test-retest stability of BETY-BQ
Time frame: From baseline to 2nd week
The Cognitive Exercise Therapy Approach Biopsychosocial Questionnaire will be repeated on 30 individuals with a 2-week interval.
Internal consistency of BETY-BQ
Time frame: Baseline
Cognitive Exercise Therapy Approach Biopsychosocial Questionnaire. Minimum and maximum values are 0 and 4 points, respectively. Higher scores mean a worse outcome.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Harun Gençosmanoğlu, PT, MSc principal investigator
Karabük University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temporomandibular Disorder and Temporomandibular Joint Disorders, run by Hacettepe University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Harun Gençosmanoğlu, PT, MSc (+903704189093 ext. 9093, harungencosmanoglu@karabuk.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity of BETY-BQ in measuring depression (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.