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Recruiting NCT07130630

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

Observational Knee Osteoarthritis (Knee OA)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Completion of Vietnamese Pain Self-Efficacy Questionnaire (PSEQ).
Who it may be relevant to
Registry conditions: Knee Osteoarthritis (Knee OA). Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Vietnam
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other 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.

Primary outcome measures

  • Internal consistency and test-retest reliability of the Vietnamese version of the Pain Self-Efficacy Questionnaire (VIET-PSEQ) [Time frame: Baseline and follow-up at Day 3 for test-retest group]
Secondary outcome measures (1)
  • Convergent validity of the VIET-PSEQ via correlation with EQ-5D-5L index score [Time frame: At baseline assessment]

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Vietnam · 1 center
  • Gia Dinh People's Hospital — Ho Chi Minh City

Identifiers

NCT: NCT07130630 · 113/NDGĐ- HĐĐĐ

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗