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Not Yet RecruitingNCT07378501

Thai Version of the Pediatric Quality of Recovery Score (PedSQoR): Translation and Psychometric Validation Study

Translation and Psychometric Validation of the Thai Version of the Pediatric Quality of Recovery Score (Thai-PedsQoR)

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
130 (estimated)
Sponsor
Mahidol University · Academic / Other
Sex
All
Age
2 Years – 17 Years
Healthy volunteers
Not accepted

Summary

Postoperative recovery in children is a complex, multidimensional process that differs substantially from recovery in adults, encompassing physical comfort, emotional well-being, behavioral changes, and psychosocial functioning. While several validated Quality of Recovery (QoR) instruments are widely used in adult perioperative care, equivalent tools for pediatric populations remain limited, particularly in non-English-speaking settings. The Pediatric Quality of Recovery score (PedSQoR) was recently developed to address this gap by providing a comprehensive, patient- and proxy-reported outcome measure specifically designed for children. However, a culturally adapted and psychometrically validated Thai version of this instrument is currently unavailable. The primary objective of this study is to translate and culturally adapt the PedSQoR into Thai in accordance with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines for patient-reported outcome measures. The secondary objective is to evaluate the psychometric properties of the Thai-PedSQoR, including content validity, construct validity, reliability, and responsiveness, in Thai pediatric surgical patients. This clinical applied research will be conducted at Siriraj Hospital and will include children aged 2-17 years undergoing elective surgery or procedures requiring anesthesia. The translation process will involve forward and backward translation, expert committee review, and cognitive debriefing with parents and children to ensure conceptual equivalence and cultural appropriateness. Psychometric validation will be performed in a cohort of 130 participants, stratified into proxy-report and self-report groups according to age. The Thai-PedSQoR will be administered on postoperative days 2, 6, and 21, alongside anchor measures including pain and global recovery visual analog scales. The expected outcome of this study is a reliable and valid Thai version of the PedSQoR that can be used in clinical practice, quality improvement initiatives, and future pediatric perioperative research, supporting patient-centered and value-based pediatric surgical care in Thailand.

Conditions

Timeline

Start date
2026-04-01
Primary completion
2027-01-31
Completion
2027-06-30
First posted
2026-01-30
Last updated
2026-01-30

Locations

1 site across 1 country: Thailand

Source: ClinicalTrials.gov record NCT07378501. Inclusion in this directory is not an endorsement.