Anaesthetics Department, Queensland Children's Hospital, Queensland Health, South Brisbane, Australia.
Child Health Research Centre, School of Medicine, The University of Queensland, Brisbane, Australia.
Trials. 2023 Jul 8;24(1):446. doi: 10.1186/s13063-023-07480-0.
Children undergoing anaesthetic induction experience peri-operative anxiety associated with negative outcomes including emergence delirium, short- and long-term maladaptive behaviour and increased postoperative analgesic requirements. This stems from children's limited ability to communicate, cope, and regulate intense emotions, leading to high dependency on parental emotional regulation. Previous interventions including video modelling, education and distraction techniques before and during anaesthetic induction have demonstrated significant reduction of anxiety levels. No existing interventions combines evidenced-based psychoeducation video with distraction techniques to support parents to moderate peri-operative anxiety. This study aims to test the efficacy of the Take5 video (now referred to as 'Take5'), a short and cost-efficient intervention for child peri-operative anxiety.
A randomised, controlled, superiority trial of Take5 compared to standard care. Take5 was developed by paediatric anaesthetists, child psychologists and a consumer panel of parents of children who had experienced surgery and anaesthesia. Children aged 3-10 years presenting for elective surgery at a quaternary paediatric facility will be randomly allocated to the intervention group or standard care. Intervention group parents will be shown Take5 prior to accompanying their child for anaesthesia induction. Primary outcomes include child and parent anxiety at induction, measured by the Modified Yale Preoperative Anxiety Scale Short Form (mYPAS-SF), the Peri-operative Adult-Child Behavior Interaction Scale (PACBIS) and the Induction Compliance Checklist (ICC). Secondary outcomes include post-operative pain, emergence delirium, parental satisfaction, cost-effectiveness, parent and child psychological well-being at 3 months post procedure and video intervention acceptability.
Perioperative anxiety is associated with negative outcome in children including higher pharmacological intervention, delayed procedures, and poor post-recovery outcomes resulting in financial burden on health systems. Current strategies minimising paediatric procedural distress are resource-intensive and have been inconsistent in reducing anxiety and negative postoperative outcomes. The Take5 video is an evidence-driven resource that is designed to prepare and empower parents. The success of Take5 will be evaluated by measuring differences in patient (acute and 3-month), family (satisfaction, acceptability), clinician (feasibility) and health service (cost) outcomes, with each anticipated to benefit children.
Australian and New Zealand Clinical Trial Registry (ACTRN12621001337864) and Children's Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC/21/QCHQ/73894).
接受麻醉诱导的儿童会经历围手术期焦虑,这与负面结果有关,包括术后谵妄、短期和长期适应不良行为以及增加术后镇痛需求。这源于儿童沟通、应对和调节强烈情绪的能力有限,导致对父母情绪调节的高度依赖。以前的干预措施,包括在麻醉诱导前和期间进行视频建模、教育和分散注意力的技术,已经证明可以显著降低焦虑水平。目前还没有将基于证据的心理教育视频与分散注意力技术相结合的干预措施来支持父母减轻围手术期焦虑。本研究旨在测试 Take5 视频(现称为“Take5”)的疗效,这是一种针对儿童围手术期焦虑的简短且经济高效的干预措施。
这是一项与标准护理相比,对 Take5 进行随机、对照、优势试验。Take5 由儿科麻醉师、儿童心理学家和经历过手术和麻醉的儿童家长组成的消费者小组共同开发。在一家四级儿科医院接受择期手术的 3-10 岁儿童将被随机分配到干预组或标准护理组。干预组的父母将在陪同孩子接受麻醉诱导前观看 Take5。主要结局包括使用改良耶鲁术前焦虑量表短表(mYPAS-SF)、围手术期成人-儿童行为互动量表(PACBIS)和诱导依从性检查表(ICC)测量诱导时儿童和家长的焦虑。次要结局包括术后疼痛、术后谵妄、父母满意度、成本效益、术后 3 个月父母和儿童的心理健康状况以及视频干预的可接受性。
围手术期焦虑与儿童的负面结果相关,包括更高的药物干预、延迟手术以及恢复后结果不佳,从而给卫生系统带来经济负担。目前,减轻儿科程序痛苦的策略资源密集且不一致,无法降低焦虑和负面术后结果。Take5 视频是一种有证据支持的资源,旨在为父母提供准备和赋权。通过测量患者(急性和 3 个月)、家庭(满意度、可接受性)、临床医生(可行性)和卫生服务(成本)的差异来评估 Take5 的成功,预计每个方面都将使儿童受益。
澳大利亚和新西兰临床试验注册中心(ACTRN12621001337864)和昆士兰儿童医院和卫生服务机构人类研究伦理委员会(HREC/21/QCHQ/73894)。