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

May 15, 2026 updated by: Mahidol University

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Issada Jindawatthana, Pediatric Anesthesiologist
  • Phone Number: +61431908917
  • Email: issada.j@gmail.com

Study Contact Backup

  • Name: Ornin Chintabanyat, Pediatric Anesthesiologist
  • Phone Number: +66891515629
  • Email: orn.in.tu@gmai.com

Study Locations

  • Thailand
    • Bangkok
      • Bangkok Noi, Bangkok, Thailand, 10700
        • Recruiting
        • Siriraj Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful Translation and Cultural Adaptation of the Thai Pediatric Quality of Recovery Questionnaire (Thai-PedsQoR)
Time Frame: With in 2 months after IRB approval
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Internal Consistency of the Thai-PedsQoR
Time Frame: From initial questionnaire administration to repeat assessment within 21 days
Internal 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.
From initial questionnaire administration to repeat assessment within 21 days
Responsiveness of the Thai Pediatric Quality of Recovery Questionnaire (Thai-PedsQoR)
Time Frame: From initial questionnaire administration to repeat assessment within 21 days
Responsiveness 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..
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)
Time Frame: Within 3 months after IRB approval
Item-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.
Within 3 months after IRB approval
Scale-Level Content Validity Index (S-CVI) of the Thai Pediatric Quality of Recovery Questionnaire (Thai-PedsQoR)
Time Frame: Within 3 months after IRB approval
Scale-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.
Within 3 months after IRB approval
Content Validity Ratio (CVR) of the Thai Pediatric Quality of Recovery Questionnaire (Thai-PedsQoR)
Time Frame: Within 3 months after IRB approval
Content 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.
Within 3 months after IRB approval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

January 7, 2026

First Submitted That Met QC Criteria

January 22, 2026

First Posted (Actual)

January 30, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Si 1069/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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