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Clinical Trials/NCT05687175
NCT05687175
Completed
N/A

Study to Translate and Determine the Validity and Reliability of Malay Version of painDETECT Questionnaire (PDQ-M)

University Malaysia Sarawak4 sites in 1 country97 target enrollmentFebruary 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Neuropathic Pain, Nociceptive Pain
Sponsor
University Malaysia Sarawak
Enrollment
97
Locations
4
Primary Endpoint
PDQ-M scores
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The translation and cultural adaptation process of the English version of PDQ will be performed based on international guidelines. Subsequently, patients with neuropathic and nociceptive pain based on clinician's diagnoses will be recruited to complete three-type numeric rating scale (NRS) of pain followed by PDQ-M and SF-36 questionnaire. Patients' socio-demographic data and clinical characteristics will be reported using frequency for categorical variables and mean with standard deviation for continuous variables. Normality will be assessed using Shapiro Wilk test and histograms for continuous variables. Data will be compared between groups using chi-square test (for categorical variables) and t-test or Mann-Whitney's U test (for continuous variables). Suitability of PDQ-M data for factor analysis will be verified using the Bartlett's test of sphericity and the Kaiser-Mayer-Olkin (KMO) measure of sampling adequacy. Parallel analysis will performed to obtain the suitable factors. Construct validity will be investigated by exploratory factorial analysis (EFA) with varimax rotation. A factor loading of >0.40 will be used to determine the items for each factor. The internal consistency of the questionnaire will be assessed using Cronbach's alpha test. A p value of <0.05 is taken as statistically significant.

Registry
clinicaltrials.gov
Start Date
February 1, 2020
End Date
June 30, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Malaysia Sarawak
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • able to read and understand the Malay language
  • diagnosed to have neuropathic or nociceptive pain by clinician
  • stable disease condition
  • pain duration of at least 4 weeks

Exclusion Criteria

  • acute illness
  • poor mental health status that prevents them from understanding or responding to the proposed questions
  • cultural or language barrier

Outcomes

Primary Outcomes

PDQ-M scores

Time Frame: 2-5 weeks

Total of PDQ-M scores

Study Sites (4)

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