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临床试验/NCT06186830
NCT06186830招募中不适用

Validity, Reliability and Responsiveness of the Cognitive Exercise Therapy Approach Biopsychosocial Questionnaire in Individuals with Temporomandibular Disorder

Hacettepe University2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2023年12月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
2
主要终点
Validity of BETY-BQ in measuring depression

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Having received a diagnosis of temporomandibular disorder

排除标准

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

结局指标

主要结局

Validity of BETY-BQ in measuring depression

时间窗: 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

时间窗: 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 function

时间窗: Baseline

Mandibular Function Impairment Questionnaire. Minimum and maximum values are 0 and 4 points, respectively. Higher scores mean a worse outcome.

Validity of BETY-BQ in measuring anxiety

时间窗: 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

时间窗: 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

时间窗: Baseline

Craniomandibular Pain and Disability Inventory. Minimum and maximum values are 0 and 3 points, respectively. Higher scores mean a worse outcome.

Test-retest stability of BETY-BQ

时间窗: 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

时间窗: Baseline

Cognitive Exercise Therapy Approach Biopsychosocial Questionnaire. Minimum and maximum values are 0 and 4 points, respectively. Higher scores mean a worse outcome.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Harun Gençosmanoğlu

Principal Investigator

Karabuk University

研究点 (2)

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