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Development and Validation of the Paediatric Scale for Quality of Recovery in the Post-Anaesthesia Care Unit (PedSQoR-PACU)

20 de mayo de 2026 actualizado por: Issada Jindawatthana, Mahidol University

Development and Validation of the Paediatric Scale for Quality of Recovery in the Post-Anaesthesia Care Unit (PedSQoR-PACU)

This project aims to develop and test a new questionnaire to measure how well children recover in the post-anaesthesia care unit (PACU). Currently, children in PACU are mainly assessed using discharge readiness criteria, but these do not fully capture the child's recovery experience or overall wellbeing. Participants will be children aged 2-17 years having elective procedures requiring anaesthesia or sedation, and their parents/caregivers where proxy reporting is needed for younger children. The study will be conducted in stages, including interviews to identify important aspects of recovery, expert review of draft questions, testing of question clarity and acceptability, and field testing of the questionnaire in PACU at planned time points during recovery. Clinical information routinely collected as part of care, such as pain scores, nausea vomiting, airway or oxygen events, and length of stay in PACU, will also be examined to assess how well the questionnaire performs. The expected outcome is a child-centred, practical, and reliable PACU recovery measure that can be used in clinical care, quality improvement, and future research.

Descripción general del estudio

Estado

Aún no reclutando

Descripción detallada

This project aims to address an important gap in paediatric postoperative care. Children recovering in the post-anaesthesia care unit (PACU) are commonly assessed using physiologic discharge-readiness criteria, which focus mainly on safety parameters such as consciousness, breathing, circulation, and readiness to leave PACU. Although these measures are essential for clinical decision-making, they do not fully capture the child's actual recovery experience, including symptoms such as pain, nausea or vomiting, distress, discomfort, tiredness, or poor behavioural recovery. As a result, two children may both meet discharge criteria yet have very different quality of recovery.

At present, there is no well-established child-centred questionnaire designed specifically to measure quality of recovery during the immediate PACU period. This project therefore aims to develop and test a new questionnaire that better reflects what matters to children, families, and clinicians during early recovery after anaesthesia and surgery.

The study will include children aged 2-17 years undergoing elective procedures requiring anaesthesia or sedation, with parent/caregiver proxy reporting used where appropriate for younger children. This is a multicentre collaboration. The Siriraj Hospital site will be involved in Step 1, the qualitative item-generation phase, and Step 4, the field-testing / survey administration phase. In Step 1, interviews with children, parents/caregivers, and clinicians will identify the most important aspects of recovery. In Step 4, the questionnaire will be tested in PACU and compared with routinely collected clinical indicators. The expected outcome is a practical, reliable, and child-centred PACU recovery measure for use in clinical care, quality improvement, and future research.

Tipo de estudio

De observación

Inscripción (Estimado)

200

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Issada Jindawatthana, MD.
  • Número de teléfono: +66624196194
  • Correo electrónico: issada.j@gmail.com

Ubicaciones de estudio

    • Bangkok
      • Bangkok Noi, Bangkok, Tailandia, 10700
        • Siriraj Hospital
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

The study population will include children aged 2-17 years undergoing elective surgery, procedure, or imaging under anaesthesia or sedation at Siriraj Hospital, and their parents/caregivers where proxy reporting is applicable. Children aged 8-17 years may provide self-report data, while parents/caregivers may provide proxy-report data for younger children and participate in qualitative interviews where relevant.

Descripción

Inclusion criteria

  • Children aged 8-17 years for self-report version
  • Parents/caregivers of children aged 2-7 years for proxy-report version
  • Elective surgery/procedure under anaesthesia
  • Planned recovery in PACU
  • ASA I-IV
  • Able to communicate in the prespecified site language (Thai - in Siriraj Hospital site)
  • Informed consent/assent obtained as applicable Exclusion criteria
  • Unable to communicate in the prespecified site language (Thai - in Siriraj Hospital site)
  • Urgent or emergency surgery/procedure
  • Not planned to recover in PACU, including planned direct transfer from theatre to ICU
  • Developmental delay or other condition limiting comprehension for interview participation or questionnaire completion
  • Not available for an uninterrupted interview or questionnaire completion.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Children
Children aged 8-17 years undergoing elective surgery, procedure, or imaging under anaesthesia or sedation. Participants will complete study assessments relating to early recovery in the post-anaesthesia care unit (PACU). This is an observational study and no intervention is assigned.
Parent/caregiver
Parents or primary caregivers of participating children, or of children aged 2-7 years where proxy reporting is required. Participants will provide proxy-reported assessments about their child early recovery phase. This is an observational study and no intervention is assigned.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
PedsQoR-PACU questionnaire score
Periodo de tiempo: Perioperative/Periprocedural (Day of surgery)
The primary outcome is the PedsQoR-PACU questionnaire score, a measure of early postoperative recovery in children in the post-anaesthesia care unit (PACU). The questionnaire will be completed either by the child (self-report, where age-appropriate) or by a parent/caregiver (proxy report, where applicable). Higher scores will indicate better quality of recovery.
Perioperative/Periprocedural (Day of surgery)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Internal consistency of the PedsQoR-PACU questionnaire
Periodo de tiempo: Perioperative/Periprocedural (Day of surgery)
Internal consistency of the PedsQoR-PACU questionnaire will be evaluated using Cronbach's alpha. Higher values indicate greater internal consistency among questionnaire items.
Perioperative/Periprocedural (Day of surgery)
Test-retest reliability of the PedsQoR-PACU questionnaire
Periodo de tiempo: Perioperative/Periprocedural (Day of surgery)
Test-retest reliability will be assessed in a subset of participants who complete a repeat assessment at T2b. Reliability will be evaluated using appropriate agreement statistics. Higher values indicate greater stability of repeated scores.
Perioperative/Periprocedural (Day of surgery)
Child-parent agreement for the PedsQoR-PACU questionnaire score
Periodo de tiempo: Perioperative/Periprocedural (Day of surgery)
Agreement between child self-report and parent proxy report will be assessed when both are available at the same PACU time point. Agreement will be evaluated using appropriate agreement statistics, such as intraclass correlation coefficients or weighted kappa. Higher values indicate better agreement.
Perioperative/Periprocedural (Day of surgery)
Construct validity of the PedsQoR-PACU questionnaire score
Periodo de tiempo: Perioperative/Periprocedural (Day of surgery)
Construct validity will be examined by assessing associations between PedsQoR-PACU scores and relevant clinical indicators of PACU recovery, such as pain scores, rescue analgesia, postoperative nausea/vomiting, respiratory support, airway events, and PACU length of stay.
Perioperative/Periprocedural (Day of surgery)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

15 de junio de 2026

Finalización primaria (Estimado)

31 de julio de 2027

Finalización del estudio (Estimado)

31 de julio de 2027

Fechas de registro del estudio

Enviado por primera vez

15 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

20 de mayo de 2026

Publicado por primera vez (Actual)

28 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

28 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

20 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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