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

Mahidol University

Status: Begins enrollment in 1 month

Conditions: Pediatric Quality of Recovery

Study type: Observational

Funder types: Other

Identifiers

NCT07378501

Si 1069/2025

Details and patient eligibility

About

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pediatric patients aged 2-17 years undergoing day surgery/intervention or surgery/intervention requiring postoperative hospital admission.
• ASA Physical Status I-III.

Exclusion criteria

• Patients or parents/guardians who are unable to communicate in Thai.
• Urgent or emergent surgery.
• Children with significant developmental delay or severe systemic disease that interferes with activities of daily living.
• Parents, guardians, or patients who, in the opinion of the investigator, are unlikely to be available to complete follow-up.

Trial design

130 participants in 1 patient group

Pediatric patients undergoing surgery

Description:

Pediatric patients undergoing surgery who complete the Thai-PedsQoR questionnaire, either by self-report or proxy-report. No intervention or group comparison is performed.