A noninferiority trial on information-based video versus self-selected video distraction technique for preoperative anxiety reduction in school children: Prepare trial.

Abstract

Distraction techniques using smartphones to watch cartoon videos and play videogames have been successfully used to reduce preoperative anxiety in school children. However, the literature about the use of video-based preoperative information technique for anxiety reduction in that age group still remains understudied with conflicting results. We hypothesized that there would be no meaningful difference in anxiety score at induction period between the information-based video versus self-selected video distraction technique. Eighty-two children between 6 and 12 years undergoing surgery were randomized to self-selected video (n = 41) and information-based video (n = 41) distraction group in this prospective, randomized, noninferiority trial. Children in self-selected video group were shown video of their choice using smart phones, while children in the information-based video group were shown video of operation theater (OT) set up and induction procedure. The children were taken inside operating room along with parents watching the respective videos. Modified Yale Preoperative Anxiety Scale (m-YPAS), just before induction of anesthesia was recorded as the primary outcome. Induction compliance checklist score, anxiety of the parents, and short-term postoperative outcomes in 15 days (telephonically) were recorded as secondary outcomes. The mean difference in the baseline mYPAS score (95% CI) between the two groups was -2.7 (-8.2 to 2.8, p = .33) and -6.39 (-12.74 to -0.44, p = .05) just before the induction period. The upper bound of the 95% CI did not cross the value of 8, which was the noninferiority margin decided prior to study commencement. 70.73% cases had perfect induction in the self-selected video distraction group, compared to 68.29% in the information-based video group. After 15 days of postoperative follow-up, participants in the self-selected video group had a larger proportion of negative outcomes (53.7%) compared to information-based video group (31.7%), p = .044. Information-based technique using smart phone is non inferior to self-selected video-based distraction-based technique in decreasing PA with an additional advantage of decreasing postoperative short-term negative outcomes. CTRI identifier: CTRI/2020/03/023884.