Background: The purpose of this study was to develop a new tool, the Pain Sleep questionnaire, consisting of 20 items (PS-20) for measuring pain-related sleep disturbances in pain clinic patients, and to examine its reliability and validity.

Methods: The internal consistency, criterion validity compared with the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36v2), and construct validity of the PS-20 were tested.

Results: A total of 125 patients participated in this study. Cronbach's alpha coefficient was 0.969, indicating good internal consistency. The PS-20 score correlated moderately with the physical component summary of SF-36v2 and correlated weakly with the mental component summary of SF-36v2. From the graphical model using the Akaike information criterion and the Categorical principal component analysis, the items were divided into four domains: physical pain, trouble falling asleep, awakened by pain, and general health problems.

Conclusions: The PS-20 was shown to be a valid and reliable questionnaire scale for measuring pain-related sleep disturbances among pain clinic patients.

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