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Reliability, Validity of The Turkish Version of Craniofacial Pain and Disability Inventory

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ClinicalTrials.gov Identifier: NCT03837587
Recruitment Status : Recruiting
First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Halime ARIKAN, Gazi University

Tracking Information
First Submitted Date February 5, 2019
First Posted Date February 12, 2019
Last Update Posted Date February 12, 2019
Actual Study Start Date October 1, 2018
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 8, 2019)
  • Craniofacial Pain and Disability Inventory [ Time Frame: 10 minutes ]
    Craniofacial Pain and Disability Inventory is a questionnaire that development to individuals with temporomandibular disorders. Each item is scored between 0-3. The total score range from 0 to 63, and a high score indicate a high level of discomfort. It is valid and reliable a questionnaire in clinic. Therefore, Turkish version must do.
  • Jaw Functional Limitation Scale-20 [ Time Frame: 10 minutes ]
    Jaw Functional Limitation Scale-20 is a questionnaire that development to individuals with temporomandibular disorders. This questionnaire evaluates conditions of disability. Each item is scored between 0-10. It mean that "0= no limitation" and "10= severe limitation".The total score range from 0 to 200, and a high score indicate a high level of discomfort. It is valid and reliable a questionnaire in clinic. Therefore, Turkish version must do.
  • Jaw Functional Limitation Scale-8 [ Time Frame: 5 minutes ]
    Jaw Functional Limitation Scale-8 is a questionnaire that development to individuals with temporomandibular disorders. This questionnaire evaluates conditions of disability. It is short form of Jaw Functional Limitation Scale-20. Each item is scored between 0-10. It mean that "0= no limitation" and "10= severe limitation".The total score range from 0 to 80, and a high score indicate a high level of discomfort. It is valid and reliable a questionnaire in clinic. Therefore, Turkish version must do.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Reliability, Validity of The Turkish Version of Craniofacial Pain and Disability Inventory
Official Title Reliability, Validity of The Turkish Version of Craniofacial Pain and Disability Inventory
Brief Summary This study, we are aim to make the Turkish version validity and reliability of the Cranifacial Pain and Disability Inventory, Jaw Functional Limitation Scale-20, and Jaw Functional Limitation Scale-8.
Detailed Description Approximately 60% of individuals with temporomandibular disorders (TMD) reported increased pain intensity from midlevel to severe. This was seen at the end of the intervention or work related activities in the quarter of individuals. Therefore, the correct diagnosis of TMD is very important to reduce the economic cost. Craniofacial Pain and Disability Inventory (CF-PDI) is designed based on a biopsychosocial approach. Evidence has shown that CF-PDI is an well-structured, internal consistency, repeatable and valid, and that an objective outcome for the evaluation of pain and discomfort in patients with craniofacial pain. There is no Turkish version and validity study of CF-PDI. Each item is scored between 0-3. The total score ranged from 0 to 63, and a high score indicate a high level of discomfort. The aim of this study was to evaluate the validity and reliability of the Turkish version of CF-PDI. The study of validity and reliability is planned with 105 individuals with TMD. The sociodemographic characteristics of the individuals will be questioned by the investigators and then the patients will be evaluated with CF-PDI, Neck Disability Index (NDI), Tampa Scale for Kinesiophobia (TSK), Pain Catastrophizing Scale (PCS), Headache Impact Test-6 (HIT-6), Jaw Functional Limitation Scale (JFLS) (Turkish version) and Visual Analogue Scale (VAS). The test-retest will be re-administered by face-to-face interview technique after 1 week. The results will be analyzed using the SPSS version 22.0 computer package program.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with temporomandibular disorders between the ages of 18-50
Condition Temporomandibular Joint Disorders
Intervention Not Provided
Study Groups/Cohorts Patients group
Patients with temporomandibular disorders
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 8, 2019)
105
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 1, 2020
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Having a temporomandibular disorder
  • Individuals who suited Temporomandibular Disorders/ Research Diagnostic Criteria classification

Exclusion Criteria:

  • Pregnant,
  • Canser,
  • Trauma,
  • Neurologic disorder,
  • Infection,
  • Trigeminal or postherpatic neuralgia
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Halime ARIKAN, MSc 05465765132 halimearikan92@gmail.com
Contact: Seyit ÇITAKER, Prof. Dr. 05336212449 scitaker@gazi.edu.tr
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT03837587
Other Study ID Numbers 77082166-604.01.02-
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Supporting Materials: Clinical Study Report (CSR)
Responsible Party Halime ARIKAN, Gazi University
Study Sponsor Gazi University
Collaborators Not Provided
Investigators
Study Chair: Seyit ÇITAKER, Prof. Dr. Gazi University
PRS Account Gazi University
Verification Date February 2019