Translation and Validation of Malay Version of painDETECT Questionnaire (PDQM)

January 6, 2023 updated by: University Malaysia Sarawak

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

97

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
      • Kuching, Malaysia
        • Sarawak General Hospital
      • Melaka, Malaysia
        • Malacca General Hospital
      • Putrajaya, Malaysia
        • Putrajaya Hospital
    • Penang
      • Pulau Pinang, Penang, Malaysia
        • Penang General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who have been diagnosed to have neuropathic or nociceptive pain by clinicians, with stable disease condition and pain duration of at least 4 weeks prior to recruitment.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Neuropathic pain
Questionnaire administration and socio-demographic data collection
Other: Questionnaire
Questionnaire administration (PDQ-M, NRS, SF-36)
Nociceptive pain
Questionnaire administration and socio-demographic data collection
Other: Questionnaire
Questionnaire administration (PDQ-M, NRS, SF-36)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PDQ-M scores
Time Frame: 2-5 weeks
Total of PDQ-M scores
2-5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Malaysia Sarawak

Collaborators

Persatuan Diabetes Malaysia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

January 6, 2023

First Submitted That Met QC Criteria

January 6, 2023

First Posted (Actual)

January 18, 2023

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 6, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDQ-M

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe