Effectiveness of an App for Reducing Preoperative Anxiety in Children: A Randomized Clinical Trial.

Importance: Effective methods to reduce children's preoperative anxiety (such as giving information beforehand, organizing a tour of the operating room [OR] before the intervention, and incorporating clown physicians) may be difficult to implement for some hospitals, as they are time-consuming and expensive and require hospital staff to be performed.

Objective: To test the effectiveness of Clickamico, an app that shows clown physicians giving a comical and informative tour of the OR, for reducing preoperative anxiety in children.

Design, Setting, And Participants: This unblinded randomized clinical trial included 40 children aged 6 to 11 years undergoing a planned surgical intervention at a third-level Italian pediatric hospital from December 2013 to September 2014 randomized into experimental (n = 20) and control (n = 20) groups.

Interventions: The experimental intervention was a 6-minute video showing 2 clown physicians visiting the OR and explaining to each other what is in the OR in a joking way. The video was shown on a tablet to children in the experimental group the afternoon preceding a planned surgical procedure. The control intervention was the standard informative intervention regarding the surgical procedure the next day.

Main Outcomes And Measures: The main outcome was preoperative anxiety. Preoperative anxiety was measured before the experimental and control interventions and immediately before entering the OR using the modified Yale Preoperative Anxiety Scale (m-YPAS).

Results: The experimental and control groups were homogeneous with regard to age (mean [SD] age, 8.8 [2.5] vs 8.6 [2.2] years), sex (female, 11 [55.0%] vs 9 [45.0%]), parents' age (mean [SD] age, 41.8 [6.2] vs 41.3 [5.0] years), and previous surgical procedures (already underwent surgical procedure, 9 [45.0%] vs 10 [50.0%]). The initial mean (SD) m-YPAS scores were 37.3 (21.7) and 37.1 (13.8) for the experimental and control groups, respectively; the mean (SD) m-YPAS scores when entering the OR were 33.0 (18.4) and 48.6 (15.9), respectively (P = .009). The mean (SD) difference between the m-YPAS score at the first and second measurements of each participant was -2.8 (7.2) in the experimental group and 10.7 (10.8) in the control group. The 13.5-point difference between these averages was statistically significant (P = .003).

Conclusions And Relevance: The app was effective in reducing preoperative anxiety in Italian children admitted to an Italian National Health System pediatric hospital and may act as a substitute for staff-provided interventions, allowing possible reductions of hospital costs.

Trial Registration: clinicaltrials.gov Identifier: NCT01688115.