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OpenTrials
Completed

NCT Number: NCT05687175

Translation and Validation of Malay Version of painDETECT Questionnaire

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Penang General Hospital, Pulau Pinang, Malaysia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Questionnaire

Other

Questionnaire administration (PDQ-M, NRS, SF-36)

Primary outcomes

  1. PDQ-M scores

    Time frame: 2-5 weeks

    Total of PDQ-M scores

Sponsors and collaborators

Lead sponsor

University Malaysia Sarawak

Other

Collaborators

  • Persatuan Diabetes Malaysia

Registry information

Official study title

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

Acronym: PDQM

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 18, 2023
Registry last updated
Jan 18, 2023

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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