[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637660":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":29,"studyPopulation":30,"armGroups":31,"interventions":26,"overallOfficials":26,"centralContacts":38,"locations":44,"responsibleParty":63,"collaborators":67,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":84,"studyType":85,"phases":26,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Mahidol University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"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\u002Fcaregiver (proxy report, where applicable). Higher scores will indicate better quality of recovery.","Perioperative\u002FPeriprocedural (Day of surgery)",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"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.",{"measure":18,"description":19,"timeFrame":12},"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.",{"measure":21,"description":22,"timeFrame":12},"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.",{"measure":24,"description":25,"timeFrame":12},"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\u002Fvomiting, respiratory support, airway events, and PACU length of stay.",null,{"allocation":26,"interventionModel":26,"interventionModelDescription":26,"primaryPurpose":26,"observationalModel":6,"timePerspective":28,"maskingInfo":26},"PROSPECTIVE","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.\n\nAt 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.\n\nThe study will include children aged 2-17 years undergoing elective procedures requiring anaesthesia or sedation, with parent\u002Fcaregiver 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 \u002F survey administration phase. In Step 1, interviews with children, parents\u002Fcaregivers, 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.","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\u002Fcaregivers where proxy reporting is applicable. Children aged 8-17 years may provide self-report data, while parents\u002Fcaregivers may provide proxy-report data for younger children and participate in qualitative interviews where relevant.",[32,35],{"label":33,"type":26,"description":34,"interventionNames":26},"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.",{"label":36,"type":26,"description":37,"interventionNames":26},"Parent\u002Fcaregiver","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.",[39],{"name":40,"role":41,"phone":42,"phoneExt":26,"email":43},"Issada Jindawatthana, MD.","CONTACT","+66624196194","issada.j@gmail.com",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Siriraj Hospital","RECRUITING","Bangkok Noi","Bangkok","10700","Thailand","TH",{"type":54,"coordinates":55},"Point",[56,57],100.47798,13.76266,{"lat":57,"lon":56},[60],{"name":40,"role":41,"phone":61,"phoneExt":26,"email":62},"0624196194","issada.j@mahidol.ac.th",{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Issada Jindawatthana","Principal Investigator",[68],{"name":69,"class":6},"Murdoch Childrens Research Institute","100637660","development-and-validation-of-the-paediatric-scale-for-quality-of-recovery-in-the-post-anaesthesia-care-unit-100637660",false,"NCT07610915","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)","PedSQoR-PACU","Inclusion criteria\n\n* Children aged 8-17 years for self-report version\n* Parents\u002Fcaregivers of children aged 2-7 years for proxy-report version\n* Elective surgery\u002Fprocedure under anaesthesia\n* Planned recovery in PACU\n* ASA I-IV\n* Able to communicate in the prespecified site language (Thai - in Siriraj Hospital site)\n* Informed consent\u002Fassent obtained as applicable Exclusion criteria\n* Unable to communicate in the prespecified site language (Thai - in Siriraj Hospital site)\n* Urgent or emergency surgery\u002Fprocedure\n* Not planned to recover in PACU, including planned direct transfer from theatre to ICU\n* Developmental delay or other condition limiting comprehension for interview participation or questionnaire completion\n* Not available for an uninterrupted interview or questionnaire completion.","ALL","2 Years","17 Years",{"count":82,"type":83},200,"ESTIMATED","1 Day","OBSERVATIONAL","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\u002Fcaregivers 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.",[88],"Postoperative Recovery in Children",[90,91,92,93,94,95,96],"Pediatric anesthesia","Postoperative recovery","Patient-reported outcomes","Questionnaire development","Questionnaire validation","Psychometric validation","postanesthesia-care unit","2026-10-05",{"date":99,"type":100},"2026-10-08","ACTUAL",{"date":102,"type":100},"2026-06-21",{"date":104,"type":83},"2027-07-31",{"name":5,"class":6},1]