- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07610915
Development and Validation of the Paediatric Scale for Quality of Recovery in the Post-Anaesthesia Care Unit (PedSQoR-PACU)
Development and Validation of the Paediatric Scale for Quality of Recovery in the Post-Anaesthesia Care Unit (PedSQoR-PACU)
Descripción general del estudio
Estado
Condiciones
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
Inscripción (Estimado)
Contactos y Ubicaciones
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:
- Issada Jindawatthana, MD.
- Número de teléfono: 0624196194
- Correo electrónico: issada.j@mahidol.ac.th
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
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
¿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
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 433/2569(IRB4)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .