- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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)
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Issada Jindawatthana, MD.
- 전화번호: +66624196194
- 이메일: issada.j@gmail.com
연구 장소
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Bangkok
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Bangkok Noi, Bangkok, 태국, 10700
- Siriraj Hospital
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연락하다:
- Issada Jindawatthana, MD.
- 전화번호: 0624196194
- 이메일: issada.j@mahidol.ac.th
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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PedsQoR-PACU questionnaire score
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Internal consistency of the PedsQoR-PACU questionnaire
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 433/2569(IRB4)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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