A gamified mobile health intervention for children in day surgery care: Protocol for a randomized controlled trial.
Arja Rantala, Anna-Leena Vuorinen, Jonna Koivisto and 6 others
PMID 34859602WHAT IT FOUND
No results yet.
The trial plans to test whether adding a gamified child app to routine care and a parental app reduces preoperative anxiety and postoperative pain in children aged 7 to 12 years having day surgery. It has not shown whether the app works.
Key findings
01The trial will randomize children aged 7 to 12 years having elective day surgery in Finland to routine care plus the BuddyCare parental app and the Triumf gamified child app, or to routine care with the BuddyCare parental app.
02The primary outcome is children's preoperative anxiety, measured by the modified Yale Preoperative Anxiety Scale, where higher scores mean more anxiety and 31 or above indicates high anxiety.
03The paper describes an ongoing randomized controlled trial; at the time of writing, 40 children had been enrolled and randomized, 20 in each group.
STILL TO COME
How it was doneWhat it means for RNs
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What it does not show
This is a trial protocol, not a completed trial. It reports no outcome results, so it cannot show whether the app reduces anxiety, fear, pain, parental anxiety, or satisfaction. The trial is single-site and will include different types of day surgery, so pain results may not apply to all children. Children and parents will know their group, and nurse blinding may be broken if children discuss the app with the nurse. Many planned measures must be completed in set time windows, and some parents have not responded on time. Pain cannot be entered retrospectively. The sample size calculation assumes a 40% dropout rate, and recruitment was slowed by a new patient system and school reopening. Some 7-year-olds could not read, so the app may not work as planned for that age. Some outcomes are child self-report and may be influenced by what children think is acceptable.
The easy way to misread this
Do not conclude that the trial intervention reduces children's anxiety, fear, or pain. The intervention includes routine care, the BuddyCare parental app, and the Triumf gamified child app, and this protocol reports no outcome results.