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Идёт набор NCT07378501

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

— Наблюдательное Postoperative Recovery in Children

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Postoperative Recovery in Children. Базовые параметры: 2 лет — 17 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Таиланд
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Первичные конечные точки

  • Successful Translation and Cultural Adaptation of the Thai Pediatric Quality of Recovery Questionnaire (Thai-PedsQoR) [Срок оценки: With in 2 months after IRB approval]
Вторичные конечные точки (5)
  • Internal Consistency of the Thai-PedsQoR [Срок оценки: From initial questionnaire administration to repeat assessment within 21 days]
  • Responsiveness of the Thai Pediatric Quality of Recovery Questionnaire (Thai-PedsQoR) [Срок оценки: 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) [Срок оценки: Within 3 months after IRB approval]
  • Scale-Level Content Validity Index (S-CVI) of the Thai Pediatric Quality of Recovery Questionnaire (Thai-PedsQoR) [Срок оценки: Within 3 months after IRB approval]
  • Content Validity Ratio (CVR) of the Thai Pediatric Quality of Recovery Questionnaire (Thai-PedsQoR) [Срок оценки: Within 3 months after IRB approval]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Таиланд · 1 центр
  • Siriraj Hospital — Bangkok Noi

Публикации

  • 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

Идентификаторы

NCT: NCT07378501 · Si 1069/2025

Первоисточники (государственные реестры)

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