PDQM: Translation and Validation of Malay Version of painDETECT Questionnaire

Sponsor
University Malaysia Sarawak (Other)
Overall Status
Completed
CT.gov ID
NCT05687175
Collaborator
Persatuan Diabetes Malaysia (Other)
97
4
28.9
24.3
0.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaire

Study Design

Study Type:
Observational
Actual Enrollment :
97 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Study to Translate and Determine the Validity and Reliability of Malay Version of painDETECT Questionnaire (PDQ-M)
Actual Study Start Date :
Feb 1, 2020
Actual Primary Completion Date :
Jun 30, 2022
Actual Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm 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)

Outcome Measures

Primary Outcome Measures

  1. PDQ-M scores [2-5 weeks]

    Total of PDQ-M scores

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Penang General Hospital Pulau Pinang Penang Malaysia
2 Sarawak General Hospital Kuching Malaysia
3 Malacca General Hospital Melaka Malaysia
4 Putrajaya Hospital Putrajaya Malaysia

Sponsors and Collaborators

  • University Malaysia Sarawak
  • Persatuan Diabetes Malaysia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Malaysia Sarawak
ClinicalTrials.gov Identifier:
NCT05687175
Other Study ID Numbers:
  • PDQ-M
First Posted:
Jan 18, 2023
Last Update Posted:
Jan 18, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 18, 2023