An interventional study of Education and teaching of coping strategies in Health Literacy, Anesthesia and Anxiety, sponsored by University of Iceland. Recruiting at 1 site in Iceland. Open to participants aged 4 Years to 8 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University of Iceland · Not applicable, Interventional, and Treatment
The aim of this randomized controlled trial is to evaluate the effectiveness of an educational health game intervention for children undergoing anesthesia from the perspective of children's anxiety. Participants are divided into three groups: one plays an educational game, another gets similar educational material (story) on a website and the third receives usual care. Anxiety will be evaluated with a standard assessment tool at the medical centre and parents answer questionnaires about themselves and their child. The study is an important step into innovation in the field of patient education where computer games are used to disseminate information, teach salvation and promote faith in the child's own ability and courage. The study will provide important information on children's anxiety for anaesthesia and what the effects of the computer game are compared to other educational methods.
This study is a randomized controlled trial. This study will evaluate the effectiveness of an educational health game intervention for children undergoing anesthesia from the perspective of children's anxiety. The data will be collected from children (4-8 years old) and their parent or guardian at four different time points: the baseline, post1, post-2 and post 3-intervention.
The sample size was calculated by statistician using power calculations. According to the calculations, the targeted sample size is in total 150 children (50 per each arm) in Finland and Iceland.
Participants are recruited from daycare surgery wards in university hospitals or hospitals where children undergo various procedures under anesthesia. The recruitment will be agreed separately with the hospital and hospital workers.
Data will be collected in four different time points.
224 studies on the registry are indexed under Child Behavior; 41 are open to participants now.
This study's planned enrollment of 150 is close to the median of 140 across 197 interventional studies indexed under Child Behavior.
Browse Child Behavior studies →University of Iceland is the lead sponsor of 35 studies on the registry; 9 are open to participants now.
Compared within Child Behavior, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Children play a specially designed educational game within one week of their medical procedure. The game informs the child what to expect at the day of the procedure and teaching coping strategies
Other: Education and teaching of coping strategies
Children are read an illustrated story by their parent within one week of their medical procedure. The story informs the child what to expect at the day of the procedure and teaching coping strategies
Other: Education and teaching of coping strategies
These children get the usual care, information from their parents or doctor before the medical procedure
the intervention consists of patient education for children, the same content delivered through either an educational game and storytelling
Preoperative anxiety of children
Anxiety is measured with short version of the modified Yale Preoperative Anxiety Scale (mYPAS-SF) with observational scores from 22.9, minimal anxiety, to 100, maximal anxiety
Time frame: Through study completion, twice a day of surgery: In the waiting room before anesthesia and just before induction of anesthesia.
Plan to share: No
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University of Iceland