Translation and Validation of Malay Version of painDETECT Questionnaire

NCT ID: NCT05687175

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 97 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2022-06-30

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.

Conditions

Neuropathic Pain, Nociceptive Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Neuropathic pain

Questionnaire administration and socio-demographic data collection

Questionnaire

Intervention Type: OTHER

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

Nociceptive pain

Questionnaire administration and socio-demographic data collection

Questionnaire

Intervention Type: OTHER

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

Interventions

Questionnaire

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Persatuan Diabetes Malaysia

UNKNOWN

Sponsor Role: collaborator

University Malaysia Sarawak

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Penang General Hospital

Pulau Pinang, Pulau Pinang, Malaysia

Sarawak General Hospital

Kuching, , Malaysia

Malacca General Hospital

Malacca, , Malaysia

Putrajaya Hospital

Putrajaya, , Malaysia

Countries

Malaysia

Other Identifiers

PDQ-M

Identifier Type: -

Identifier Source: org_study_id