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临床试验/NCT07449221
NCT07449221尚未招募不适用

Cross Cultural Adaptation, Reliability &Validity of The Arabic Version of 8_Item Jaw Functional Limitation Scale In Temporomandibular Joint Disorders

Cairo University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年3月7日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Face Validity of the Arabic Version of the 8-item Jaw Functional Limitation Scale (JFLS-8)

研究概览

简要总结

The purpose of this study is to test if the translated Arabic version of the (jaw functional limitation scale -8) JFLS_8 , valid (face, content, feasibility) ,reliable (internal consistency, test retest) and culturally adapted enough to quantify the impact of temporomandibular joint (TMJ) disorders on jow function in arabic people or not?

详细描述

Temporomandibular disorders (TMD) are relatively prevalent among adults, representing a considerable health concern. These disorders negatively affect psychological well-being and overall quality of life, highlighting the importance of accurate assessment and appropriate management strategies. Consequently, there is a growing need for reliable and efficient tools to assess functional limitations associated with TMD.

The Jaw Functional Limitation Scale with 8 items (JFLS-8) is a concise, valid, and reliable instrument used for the assessment of functional limitations related to the masticatory system. It was developed as a shorter version of the JFLS-20 and has been shown to be more practical for use in busy clinical settings while maintaining strong psychometric properties. The JFLS-8 has demonstrated excellent validity and reliability and has been successfully translated and culturally adapted into several languages, confirming its effectiveness as a clinical assessment tool.

Therefore, there is a clear need to translate the JFLS-8 into an Arabic version, perform cultural adaptation, and evaluate its validity and reliability among patients with temporomandibular disorders in Arabic-speaking populations.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18 to 65 years .
  • Diagnosis of temporomandibular disorders ) jaw pain-popping sounds in the jaw -limited jaw movements - orofacial pain ) for one month at least, not receiving actual treatment for the orofacial region (splinting)
  • Being conscious and oriented.
  • Able to read and write in Arabic.
  • Both Genders were included.

排除标准

  • History of trauma (recent head or neck or TMJ severe trauma)
  • Recent surgery at the neck, head or TMJ
  • Diagnosed systemic and psychiatric diseases; diseases that may affect the TMJ, such as ankylosing spondylitis or rheumatoid arthritis; and pregnancy

结局指标

主要结局

Face Validity of the Arabic Version of the 8-item Jaw Functional Limitation Scale (JFLS-8)

时间窗: 30 minutes

It will be assessed using the Clarity Index and Expert Proportion of Clearance, judged by two expert panels (5 experts each) to evaluate whether the scale appears clear and relevant.

Content Validity of the Arabic Version of the 8-item Jaw Functional Limitation Scale (JFLS-8)

时间窗: 30 minutes

It will be assessed using the Content Validity Index (CVI) and Expert Proportion of Relevance, to confirm that the 8 items adequately cover the construct of jaw functional limitation.

Feasibility of the Arabic Version of the 8-item Jaw Functional Limitation Scale (JFLS-8)

时间窗: 30 minutes

It will be evaluated by two factors: time needed to complete the questionnaire and the missed item index (ratio of unanswered items).

Internal Consistency Reliability of the Arabic Version of the 8-item Jaw Functional Limitation Scale (JFLS-8)

时间窗: 30 minutes

It will be measured using Cronbach's alpha to confirm that all 8 items are measuring the same underlying construct.

Test-Retest Reliability of the Arabic Version of the 8-item Jaw Functional Limitation Scale (JFLS-8)

时间窗: 2 days

It will be assessed using Spearman's rank correlation coefficient, with a subset of patients completing the JFLS-8 again after 2 days under the same conditions.

次要结局

  • Visual Analogue Scale (VAS)(30 minutes)
  • Fonseca Anamnestic Index (FAI)(30 minutes)

研究者

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

Wafaa Hashem Ahmed Hasan

Principal investigator

Cairo University

研究点 (1)

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