Translation and Validation of Malay Version of painDETECT Questionnaire

NCT05687175 | Completed

• 1 other identifier: PDQ-M
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• PDQ-M scores

  Total of PDQ-M scores

  2-5 weeks

Study Arms (2)

Neuropathic pain

Questionnaire administration and socio-demographic data collection

Other: Questionnaire

Nociceptive pain

Questionnaire administration and socio-demographic data collection

Other: Questionnaire

Interventions

Questionnaire OTHER

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

Neuropathic pain; Nociceptive pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Malaysia Sarawak: lead
• Persatuan Diabetes Malaysia: collaborator

Study Sites (4)

Penang General Hospital

Pulau Pinang, Pulau Pinang, Malaysia

Location

Sarawak General Hospital

Kuching, Malaysia

Location

Malacca General Hospital

Malacca, Malaysia

Location

Putrajaya Hospital

Putrajaya, Malaysia

Location

MeSH Terms

Conditions

Neuralgia; Nociceptive Pain

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: January 18, 2023
• Study Start: February 1, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: January 18, 2023

Record last verified: 2023-01

Locations

MY (4)