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)
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Issada Jindawatthana, MD.
- 電話番号:+66624196194
- メール:issada.j@gmail.com
研究場所
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Bangkok
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Bangkok Noi、Bangkok、タイ、10700
- Siriraj Hospital
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コンタクト:
- Issada Jindawatthana, MD.
- 電話番号:0624196194
- メール:issada.j@mahidol.ac.th
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参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
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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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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PedsQoR-PACU questionnaire score
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Internal consistency of the PedsQoR-PACU questionnaire
時間枠: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
時間枠: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
時間枠: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
時間枠: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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 433/2569(IRB4)
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個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
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