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

NCT07610915 | Not Yet Recruiting

• 1 other identifier: 433/2569(IRB4)
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Recovery in Children

Keywords

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

Outcome Measures

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.

  Perioperative/Periprocedural (Day of surgery)

Secondary Outcomes (4)

• Internal consistency of the PedsQoR-PACU questionnaire

  Perioperative/Periprocedural (Day of surgery)

• Test-retest reliability of the PedsQoR-PACU questionnaire

  Perioperative/Periprocedural (Day of surgery)

• Child-parent agreement for the PedsQoR-PACU questionnaire score

  Perioperative/Periprocedural (Day of surgery)

• Construct validity of the PedsQoR-PACU questionnaire score

  Perioperative/Periprocedural (Day of surgery)

Study Arms (2)

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.

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mahidol University: lead
• Murdoch Childrens Research Institute: collaborator

Study Sites (1)

Siriraj Hospital

Bangkok Noi, Bangkok, 10700, Thailand

Location

Central Study Contacts

Issada Jindawatthana, MD.

CONTACT

+66624196194; issada.j@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 28, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)