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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
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07378501
Acronym
Thai-PedsQoR
Enrollment
130
Registered
2026-01-30
Start date
2026-05-05
Completion date
2027-06-30
Last updated
2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Recovery in Children

Keywords

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

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.

Interventions

None listed

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Successful Translation and Cultural Adaptation of the Thai Pediatric Quality of Recovery Questionnaire (Thai-PedsQoR)With in 2 months after IRB approvalCompletion 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.

Secondary

MeasureTime frameDescription
Internal Consistency of the Thai-PedsQoRFrom initial questionnaire administration to repeat assessment within 21 daysInternal consistency will be evaluated using Cronbach's alpha coefficient, which ranges from 0 to 1, with higher values indicating better internal consistency of the questionnaire items.
Responsiveness of the Thai Pediatric Quality of Recovery Questionnaire (Thai-PedsQoR)From initial questionnaire administration to repeat assessment within 21 daysResponsiveness will be assessed by changes in Thai-PedsQoR total scores over time following surgery, with higher scores indicating greater levels of the measured attributes as reported, reflecting changes in postoperative recovery trajectories in pediatric patients..
Item-Level Content Validity Index (I-CVI) of the Thai Pediatric Quality of Recovery Questionnaire (Thai-PedsQoR)Within 3 months after IRB approvalItem-level Content Validity Index (I-CVI) calculated as the proportion of experts rating each item of the Thai-PedsQoR as relevant (rating of 3 or 4 on a 4-point relevance scale). I-CVI values range from 0 to 1, with higher values indicating greater item relevance.
Scale-Level Content Validity Index (S-CVI) of the Thai Pediatric Quality of Recovery Questionnaire (Thai-PedsQoR)Within 3 months after IRB approvalScale-level Content Validity Index (S-CVI/Ave) calculated as the average of item-level content validity indices across all items of the Thai-PedsQoR. S-CVI values range from 0 to 1, with higher values indicating better overall content validity of the questionnaire.
Content Validity Ratio (CVR) of the Thai Pediatric Quality of Recovery Questionnaire (Thai-PedsQoR)Within 3 months after IRB approvalContent Validity Ratio (CVR) calculated using Lawshe's method based on expert ratings of item essentiality. CVR values range from -1 to +1, with higher values indicating greater expert agreement that an item is essential for assessing pediatric postoperative recovery.

Countries

Thailand

Contacts

CONTACTIssada Jindawatthana, Pediatric Anesthesiologist
issada.j@gmail.com+61431908917
CONTACTOrnin Chintabanyat, Pediatric Anesthesiologist
orn.in.tu@gmai.com+66891515629

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 20, 2026