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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-17
SponsorMahidol University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 2 trial groups
Group A: Children
Group B: Parent/caregiver

Trial outcomes

Primary outcomes

1

PedsQoR-PACU questionnaire score

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.

Time frame
Perioperative/Periprocedural (Day of surgery)

Secondary outcomes

1

Internal consistency of the PedsQoR-PACU questionnaire

Internal consistency of the PedsQoR-PACU questionnaire will be evaluated using Cronbach's alpha. Higher values indicate greater internal consistency among questionnaire items.

Time frame
Perioperative/Periprocedural (Day of surgery)
2

Test-retest reliability of the PedsQoR-PACU questionnaire

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.

Time frame
Perioperative/Periprocedural (Day of surgery)
3

Child-parent agreement for the PedsQoR-PACU questionnaire score

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.

Time frame
Perioperative/Periprocedural (Day of surgery)
4

Construct validity of the PedsQoR-PACU questionnaire score

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.

Time frame
Perioperative/Periprocedural (Day of surgery)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mahidol University

Lead sponsor

Murdoch Childrens Research Institute

Collaborator