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NCT Number: NCT07378501

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

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.

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Key information

Conditions

Postoperative Recovery in Children

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Siriraj Hospital

Bangkok Noi, Bangkok, 10700, Thailand

Location status: Recruiting

Location contact

Issada Jindawatthana

CONTACT

[email protected]

+66624196194

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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..

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Issada Jindawatthana, Pediatric Anesthesiologist

CONTACT

[email protected]

+61431908917

Ornin Chintabanyat, Pediatric Anesthesiologist

CONTACT

[email protected]

+66891515629

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Acronym: Thai-PedsQoR

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 30, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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