Validation and Reliability of the Vietnamese Pain Self-Efficacy Questionnaire in Knee Osteoarthritis

Официальное название

Validation and Reliability of the Vietnamese Version of the Pain Self-Efficacy Questionnaire in Patients With Knee Osteoarthritis

Обзор

This study aims to evaluate the reliability and convergent validity of the Vietnamese version of the Pain Self-Efficacy Questionnaire (VIET-PSEQ) in patients with knee osteoarthritis (KOA). Pain self-efficacy refers to a person's confidence in managing their pain and maintaining daily activities despite it. A total of 173 patients with KOA will be recruited at Gia Dinh People's Hospital using a convenient sampling method. Eligible participants are 50 years or older, diagnosed with KOA, and experiencing chronic knee pain. They will complete the VIET-PSEQ and other health-related questionnaires during an in-person interview. The study will assess internal consistency (using Cronbach's alpha), test-retest reliability (by re-assessing a subgroup after 72 hours), and convergent validity by correlating VIET-PSEQ scores with EQ-5D-5L utility index. Additionally, linear regression analysis will examine how age, sex, pain severity, and education level influence pain self-efficacy. The goal is to determine whether VIET-PSEQ is a reliable and valid tool for measuring pain self-efficacy in Vietnamese patients with KOA.

Вмешательства

• Другое Completion of Vietnamese Pain Self-Efficacy Questionnaire (PSEQ)
  Participants completed the Vietnamese version of the Pain Self-Efficacy Questionnaire (PSEQ) to assess self-efficacy beliefs related to pain management.

Первичные конечные точки

• Internal consistency and test-retest reliability of the Vietnamese version of the Pain Self-Efficacy Questionnaire (VIET-PSEQ) [Срок оценки: Baseline and follow-up at Day 3 for test-retest group]

Вторичные конечные точки (1)

• Convergent validity of the VIET-PSEQ via correlation with EQ-5D-5L index score [Срок оценки: At baseline assessment]

Критерии участия

Критерии включения

Participants will be eligible for inclusion if they meet all of the following conditions:

• Age ≥ 50 years.
• Diagnosis of knee osteoarthritis (OA) according to the criteria of the American College of Rheumatology (ACR), confirmed by:

• application of ACR criteria by the investigator at the time of enrollment; or
• a prior diagnosis documented in medical records by a rheumatologist or musculoskeletal specialist.
• Presence of chronic pain related to knee OA, with current pain intensity ≥ 1 on the Visual Analog Scale (VAS).
• No acute flare of knee pain within the past 2 weeks.
• Ability to perform activities of daily living (with or without assistance).
• Ability to read, understand, and complete questionnaires in Vietnamese.
• Willingness to participate and provide informed consent.

Критерии исключения

Participants will be excluded if they meet any of the following conditions:

• Diagnosis of severe psychiatric disorders (e.g., schizophrenia, severe anxiety disorders).
• Presence of cognitive impairment that interferes with the ability to comprehend or answer the questionnaire.
• Diagnosed with systemic inflammatory diseases such as rheumatoid arthritis, systemic lupus erythematosus, or gout.
• Presence of other chronic pain conditions (unrelated to knee OA) that are predominant and significantly affect mobility and daily functioning.
• History of intra-articular injection or knee surgery within the past 3 months.
• Questionnaire (PSEQ) with ≥ 20% of items missing or invalid.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Вьетнам · 1 центр

• Gia Dinh People's Hospital — Ho Chi Minh City

Идентификаторы

NCT: NCT07130630 · 113/NDGĐ- HĐĐĐ

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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