Validation and Reliability of the Vietnamese Version of the Pain Self-Efficacy Questionnaire in Patients With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 173
- 试验地点
- 1
- 主要终点
- Internal consistency and test-retest reliability of the Vietnamese version of the Pain Self-Efficacy Questionnaire (VIET-PSEQ)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Internal consistency and test-retest reliability of the Vietnamese version of the Pain Self-Efficacy Questionnaire (VIET-PSEQ)
时间窗: Baseline and follow-up at Day 3 for test-retest group
The primary outcomes are the internal consistency and test-retest reliability of the Vietnamese version of the Pain Self-Efficacy Questionnaire (VIET-PSEQ) among patients with knee osteoarthritis. Internal consistency will be assessed using Cronbach's alpha with a threshold of ≥ 0.70. Test-retest reliability will be evaluated using the intraclass correlation coefficient (ICC) calculated from a two-way random-effects model with absolute agreement, based on repeated assessments 3 days apart without clinical intervention.
次要结局
- Convergent validity of the VIET-PSEQ via correlation with EQ-5D-5L index score(At baseline assessment)
研究者
Khai Quang Nguyen, MD
Deputy Head, Department of Rehabilitation
Gia Dinh People Hospital