Play distraction versus pharmacological treatment to reduce anxiety levels in children undergoing day surgery: a randomized controlled non-inferiority trial

Background Perioperative experience can be one of the most distressful experiences in a child's life if not managed properly by healthcare professionals. Its consequences can extend well beyond surgery and recovery into the child's future life. Healthcare professionals have a responsibility to decrease the anxiety associated with this experience, improve the child's and the parent's experience and prevent negative consequences. This has traditionally been performed through pharmacological treatment which might have negative side effects. More developmentally appropriate distraction methods are currently being trialled globally to augment the evidence that supports their use as a similarly efficient alternative. Objectives The aim of this study was to explore the efficiency of storytelling, pictures and colouring activities as an anxiolytic intervention in comparison to the traditional pharmacological premedication technique in a non-inferiority study. Study design A randomized non-inferiority controlled trial was carried out in 168 children scheduled for day surgery. Children's perioperative anxiety was assessed by a trained anaesthetist using the modified Yale Preoperative Assessment Scale and by parents using the State-Trait Anxiety Inventory for Children. Children's vital signs were also collected preoperatively during the induction period and during the recovery period. Results The primary endpoint, which is non-inferiority in terms of anxiety as per Yale Preoperative Assessment Scale survey between play distraction and preoperative medication, was met [average score 10.95 vs. 10.94, respectively, 95% confidence interval (-0.35; 0.37); P = 0.941]. Moreover, anxiety scores of both the intervention and the control group were quite comparable as per STAIC survey [20.90 vs. 20.73, respectively, 95% confidence interval (-0.52; 0.88); P = 0.708] and in terms of vital signs. Conclusion The results indicate that the distraction technique employed can be considered as an efficient alternative to traditional pharmacological premedication for children undergoing day surgery.