Translation and Validation of Malay Version of painDETECT Questionnaire

Completed

• Conditions: Neuropathic Pain, Nociceptive Pain
• Interventions: Other: Questionnaire

• Registration Number: NCT05687175
• Lead Sponsor: University Malaysia Sarawak

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2023-01
• Study First Submitted: 2023-01-06
• Study First Submitted QC: 2023-01-06
• Last Update Submitted: 2023-01-06
• Study First Posted: 2023-01-18
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Nociceptive pain	Questionnaire	Questionnaire administration and socio-demographic data collection
Neuropathic pain	Questionnaire	Questionnaire administration and socio-demographic data collection

Primary Outcome Measures

Name	Time	Method
PDQ-M scores	2-5 weeks	Total of PDQ-M scores

Trial Locations

Locations (4)

Penang General Hospital; 🇲🇾 Pulau Pinang, Penang, Malaysia

Sarawak General Hospital; 🇲🇾 Kuching, Malaysia

Putrajaya Hospital; 🇲🇾 Putrajaya, Malaysia

Malacca General Hospital; 🇲🇾 Melaka, Malaysia