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

NCT07378501 | Recruiting

• 1 other identifier: Si 1069/2025
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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

Postoperative Recovery in Children

Keywords

Pediatric anesthesia; Postoperative recovery; Patient-reported outcomes; Questionnaire validation; Psychometric validation

Outcome Measures

Primary Outcomes (1)

• Successful Translation and Cultural Adaptation of the Thai Pediatric Quality of Recovery Questionnaire (Thai-PedsQoR)

  Completion of the translation and cultural adaptation process of the Pediatric Quality of Recovery Questionnaire (PedSQoR) into Thai, following the ISPOR guidelines. Successful adaptation is defined as finalized Thai-PedsQoR wording approved by forward translation, backward translation, expert review, and cognitive debriefing, with no unresolved major issues identified.

  With in 2 months after IRB approval

Secondary Outcomes (5)

• Internal Consistency of the Thai-PedsQoR

  From initial questionnaire administration to repeat assessment within 21 days

• Responsiveness of the Thai Pediatric Quality of Recovery Questionnaire (Thai-PedsQoR)

  From initial questionnaire administration to repeat assessment within 21 days

• Item-Level Content Validity Index (I-CVI) of the Thai Pediatric Quality of Recovery Questionnaire (Thai-PedsQoR)

  Within 3 months after IRB approval

• Scale-Level Content Validity Index (S-CVI) of the Thai Pediatric Quality of Recovery Questionnaire (Thai-PedsQoR)

  Within 3 months after IRB approval

• Content Validity Ratio (CVR) of the Thai Pediatric Quality of Recovery Questionnaire (Thai-PedsQoR)

  Within 3 months after IRB approval

Study Arms (1)

Pediatric patients undergoing surgery

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

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes pediatric patients undergoing surgical procedures who are assessed for postoperative recovery using the Thai Pediatric Quality of Recovery questionnaire (Thai-PedsQoR). Depending on the child's age and developmental ability, the questionnaire is completed either by the child (self-report) or by a parent or primary caregiver (proxy-report). Expert participants involved in content validity assessment include healthcare professionals with expertise in pediatric perioperative care and patient-reported outcome measurement.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Siriraj Hospital

Bangkok Noi, Bangkok, 10700, Thailand

RECRUITING

Related Publications (1)

• Graydon C, Stricker PA, Kelleher S, Cravero J, Karim N, Muhly WT, Lee-Archer P. Development of the Pediatric Scale for Quality of Recovery (PedSQoR). Anesthesiology. 2025 Aug 1;143(2):275-286. doi: 10.1097/ALN.0000000000005503. Epub 2025 Apr 14.

  PMID: 40227959 BACKGROUND

Central Study Contacts

Issada Jindawatthana, Pediatric Anesthesiologist

CONTACT

+61431908917; issada.j@gmail.com

Ornin Chintabanyat, Pediatric Anesthesiologist

CONTACT

+66891515629; orn.in.tu@gmai.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 21 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 30, 2026
• Study Start: May 5, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Locations

TH (1)