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NCT Number: NCT07130630

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gia Dinh People's Hospital

Ho Chi Minh City, Ho Chi Minh, 700000, Vietnam

Location status: Recruiting

Location contact

Hai H Nguyen, MD, PhD

CONTACT

[email protected]

+84 908247359

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Completion of Vietnamese Pain Self-Efficacy Questionnaire (PSEQ)

Other

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

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. Convergent validity of the VIET-PSEQ via correlation with EQ-5D-5L index score

    Time frame: At baseline assessment

    To assess the convergent validity of the VIET-PSEQ by analyzing its correlation with the EQ-5D-5L utility index. This aims to explore the association between pain self-efficacy and health-related quality of life in patients with knee osteoarthritis. Correlation will be examined using Spearman's rho or Pearson's r depending on data distribution.

Other outcomes

  1. Regression analysis of predictors of total VIET PSEQ score

    Time frame: At baseline (upon enrollment)

    Linear regression will be conducted to evaluate the association between total VIET PSEQ score and potential predictors including age, gender, pain intensity (VAS), and education level. Assumptions of the linear model will be tested. In case of non-normal distribution, data transformation or alternative models such as quantile regression will be considered.

Study contacts

Contact information is provided by the study sponsor or research team.

Khai Q Nguyen, MD, MSc

CONTACT

[email protected]

+84 704674558

Sponsors and collaborators

Lead sponsor

Khai Quang Nguyen, MD

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 19, 2025
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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