Trials. 2023 Jul 8;24(1):446. doi: 10.1186/s13063-023-07480-0.

ABSTRACT

BACKGROUND: 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.

METHODS: 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.

DISCUSSION: 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.

TRIAL REGISTRATION: 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).

PMID:37422667 | DOI:10.1186/s13063-023-07480-0