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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07610915
Acronym
PedSQoR-PACU
Enrollment
200
Registered
2026-05-28
Start date
2026-06-15
Completion date
2027-07-31
Last updated
2026-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Recovery in Children

Keywords

Pediatric anesthesia, Postoperative recovery, Patient-reported outcomes, Questionnaire development, Questionnaire validation, Psychometric validation, postanesthesia-care unit

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Mahidol University
Lead SponsorOTHER
Murdoch Childrens Research Institute
CollaboratorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
PedsQoR-PACU questionnaire scorePerioperative/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.

Secondary

MeasureTime frameDescription
Internal consistency of the PedsQoR-PACU questionnairePerioperative/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.
Test-retest reliability of the PedsQoR-PACU questionnairePerioperative/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.
Child-parent agreement for the PedsQoR-PACU questionnaire scorePerioperative/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.
Construct validity of the PedsQoR-PACU questionnaire scorePerioperative/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.

Countries

Thailand

Contacts

CONTACTIssada Jindawatthana, MD.
issada.j@gmail.com+66624196194

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 29, 2026