Accepted for/Published in: JMIR Serious Games
Date Submitted: Oct 29, 2023
Date Accepted: Jul 2, 2024
Acceptability of a serious game about proton radiotherapy designed for children aged 5 to 14 years and its potential impact on perceived anxiety: A feasibility and randomized controlled pilot trial
ABSTRACT
Background:
A web-based serious game was developed as psychological preparation for children who are going to undergo radiotherapy. The game was developed together with children with experience of radiotherapy.
Objective:
The study aimed to investigate the feasibility in terms of reach, usability, and acceptability, of a serious game about radiotherapy, and to evaluate whether it can decrease anxiety levels in children aged 5 to14 years undergoing radiotherapy.
Methods:
The study was designed as a randomized controlled pilot trial with predefined feasibility criteria. Twenty-eight children were assessed for eligibility and 23 were found to meet the inclusion criteria. They were consecutively randomized into one of two study arms. One child was excluded after randomization due to language difficulties. If randomized into Group 1, the children received the intervention (serious game) before treatment started. Children in Group 2 received the intervention after three days of treatment. Questionnaires with fixed answers were used to assess anxiety levels (an adapted version of STAIC) and experiences of gameplay (an adapted version of PENS).
Results:
The predefined feasibility criterion that the children should play the game for 20 minutes or more was not met. The second criterion, that 70% or more of the participants should return all of the questionnaires was not met either, however, more than 80% returned the PENS questionnaires.
Conclusions:
All feasibility criteria set for the study were not meet, suggesting that adaptions need to be made if a future study is going to be undertaken. There was no indication that playing the serious game decreased the children’s stated anxiety. When combining the two groups, a pattern emerged that anxiety levels decreased over time. The PENS questionnaire adapted for children showed promising results regarding player satisfaction when using the serious game within healthcare. Clinical Trial: The trial was registered at ClinicalTrials.gov:NCT04728555
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