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

20. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

200

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Thailand
    • Bangkok
      • Bangkok Noi, Bangkok, Thailand, 10700
        • Siriraj Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
PedsQoR-PACU questionnaire score
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Internal consistency of the PedsQoR-PACU questionnaire
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Mahidol University

Samarbeidspartnere

Murdoch Childrens Research Institute

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

15. juni 2026

Primær fullføring (Antatt)

31. juli 2027

Studiet fullført (Antatt)

31. juli 2027

Datoer for studieregistrering

Først innsendt

15. mai 2026

Først innsendt som oppfylte QC-kriteriene

20. mai 2026

Først lagt ut (Faktiske)

28. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 433/2569(IRB4)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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