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Набор скоро начнётся NCT07449221

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

— Наблюдательное Temporomandibular Joint Disorders

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Questionnaire Administration.
Кому может быть актуально
Состояния в реестре: Temporomandibular Joint Disorders. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
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Обзор

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?

Подробное описание

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.

Вмешательства

  • Другое Questionnaire Administration
    Participants complete the Arabic version of the 8-item Jaw Functional Limitation Scale (JFLS-8), along with reference measures (Visual Analogue Scale and Fonseca Anamnestic Index), to evaluate validity, reliability, feasibility, and cultural adaptation of the questionnaire. A subset of participants completes the JFLS-8 again after 2 days to assess test-retest reliability.

Первичные конечные точки

  • Face Validity of the Arabic Version of the 8-item Jaw Functional Limitation Scale (JFLS-8) [Срок оценки: 30 minutes]
  • Content Validity of the Arabic Version of the 8-item Jaw Functional Limitation Scale (JFLS-8) [Срок оценки: 30 minutes]
  • Feasibility of the Arabic Version of the 8-item Jaw Functional Limitation Scale (JFLS-8) [Срок оценки: 30 minutes]
  • Internal Consistency Reliability of the Arabic Version of the 8-item Jaw Functional Limitation Scale (JFLS-8) [Срок оценки: 30 minutes]
  • Test-Retest Reliability of the Arabic Version of the 8-item Jaw Functional Limitation Scale (JFLS-8) [Срок оценки: 2 days]
Вторичные конечные точки (2)
  • Visual Analogue Scale (VAS) [Срок оценки: 30 minutes]
  • Fonseca Anamnestic Index (FAI) [Срок оценки: 30 minutes]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Египет · 1 центр
  • El-Kasr Elainy jaw and dental clinics — Giza

Идентификаторы

NCT: NCT07449221 · P.T.REC/012/006224

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗