Gia Dinh People's Hospital
Ho Chi Minh City, Ho Chi Minh, 700000, Vietnam
Location status: Recruiting
NCT Number: NCT07130630
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.
Interested in participating?
Request Info50 year and older
All sexes
Observational
Ho Chi Minh City, Ho Chi Minh, 700000, Vietnam
Location status: Recruiting
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:
Exclusion criteria
Participants will be excluded if they meet any of the following conditions:
Participants completed the Vietnamese version of the Pain Self-Efficacy Questionnaire (PSEQ) to assess self-efficacy beliefs related to pain management.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Khai Quang Nguyen, MD
Other
Validation and Reliability of the Vietnamese Version of the Pain Self-Efficacy Questionnaire in Patients With Knee Osteoarthritis
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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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