Acceptability of a Serious Game About Proton Radiotherapy Designed for Children Aged 5 to 14 Years and Its Potential Impact on Perceived Anxiety: Feasibility and Randomized Controlled Pilot Trial.

Background: Children who are going to undergo radiotherapy have displayed fear and anxiety. Therefore, a web-based serious game was developed as a psychological preparation to investigate if it could affect anxiety levels. In an earlier stage, children with experience of radiotherapy had been part of the developmental process. Objective: The study aimed to investigate the feasibility in terms of reach, usability, and acceptability of a serious game about proton radiotherapy and to pilot that it did not increase anxiety levels in children aged 5 to 14 years undergoing radiotherapy. Methods: The design was a randomized controlled pilot trial with predefined feasibility criteria. In total, 28 children were assessed for eligibility, and 23 met the inclusion criteria. They were consecutively randomized into 1 of 2 study arms. One child was excluded after randomization. If randomized into arm 1, the children received the intervention before treatment started. Children in arm 2 were treated as controls. Questionnaires with fixed answers were used to assess anxiety levels (an adapted version of the State-Trait Anxiety Inventory for Children) and experiences of gameplay (an adapted version of Player Experience of Need Satisfaction [PENS]). The children were asked to answer questionnaires at 5 different measurement occasions during their radiotherapy treatment. Results: In arm 1, age ranged from 5 to 13 (mean 8.4, SD 2.4) years. In arm 2, age ranged from 5 to 11 (mean 7.6, SD 2.3) years. The sample consisted of 15 girls and 7 boys. The feasibility criterion that the children should play the game for 20 minutes or more was not met. Mean playtime for children in arm 1 was 32.1 (SD 23.8) minutes, where 18 children had played for at least 15 minutes. The criterion that 70% (n=16) or more of the participants should return all of the questionnaires was not met; however, more than 73% (n=16) returned the PENS questionnaires. The State-Trait Anxiety Inventory for Children was returned by 73% (n=16) on day 0, 77% (n=17) on day 1, 82% (n=18) on day 3, 82% (n=18) on day 6, and 86% (n=19) on day 15. Conclusions: All feasibility criteria set for the study were not met, suggesting that adaptions need to be made if a future study is to be undertaken. Further, the analysis revealed that there was no indication that playing increased the children's self-reported anxiety. The PENS questionnaire adapted for children showed promising results regarding player satisfaction when using the serious game. When studying children with severe conditions and young age, 5 measurement occasions seemed to be too many. Measuring both player satisfaction or experience and knowledge transfer would be preferable in future studies.