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.

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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. 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. 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. 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. 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.