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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 maio de 2026 atualizado 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.

Visão geral do estudo

Status

Ainda não está recrutando

Descrição detalhada

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 estudo

Observacional

Inscrição (Estimado)

200

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Issada Jindawatthana, MD.
  • Número de telefone: +66624196194
  • E-mail: issada.j@gmail.com

Locais de estudo

    • Bangkok
      • Bangkok Noi, Bangkok, Tailândia, 10700
        • Siriraj Hospital
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
PedsQoR-PACU questionnaire score
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Internal consistency of the PedsQoR-PACU questionnaire
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

15 de junho de 2026

Conclusão Primária (Estimado)

31 de julho de 2027

Conclusão do estudo (Estimado)

31 de julho de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

15 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

20 de maio de 2026

Primeira postagem (Real)

28 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

28 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

20 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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