- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07610915
Development and Validation of the Paediatric Scale for Quality of Recovery in the Post-Anaesthesia Care Unit (PedSQoR-PACU)
Development and Validation of the Paediatric Scale for Quality of Recovery in the Post-Anaesthesia Care Unit (PedSQoR-PACU)
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Issada Jindawatthana, MD.
- Telefoonnummer: +66624196194
- E-mail: issada.j@gmail.com
Studie Locaties
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Bangkok
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Bangkok Noi, Bangkok, Thailand, 10700
- Siriraj Hospital
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Contact:
- Issada Jindawatthana, MD.
- Telefoonnummer: 0624196194
- E-mail: issada.j@mahidol.ac.th
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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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.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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PedsQoR-PACU questionnaire score
Tijdsspanne: Perioperative/Periprocedural (Day of surgery)
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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.
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Perioperative/Periprocedural (Day of surgery)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Internal consistency of the PedsQoR-PACU questionnaire
Tijdsspanne: Perioperative/Periprocedural (Day of surgery)
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Internal consistency of the PedsQoR-PACU questionnaire will be evaluated using Cronbach's alpha.
Higher values indicate greater internal consistency among questionnaire items.
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Perioperative/Periprocedural (Day of surgery)
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Test-retest reliability of the PedsQoR-PACU questionnaire
Tijdsspanne: Perioperative/Periprocedural (Day of surgery)
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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.
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Perioperative/Periprocedural (Day of surgery)
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Child-parent agreement for the PedsQoR-PACU questionnaire score
Tijdsspanne: Perioperative/Periprocedural (Day of surgery)
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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.
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Perioperative/Periprocedural (Day of surgery)
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Construct validity of the PedsQoR-PACU questionnaire score
Tijdsspanne: Perioperative/Periprocedural (Day of surgery)
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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.
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Perioperative/Periprocedural (Day of surgery)
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 433/2569(IRB4)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
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