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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Game playing | Experimental | 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 |
|
| Story telling | Active Comparator | 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 |
|
| Usual care | No Intervention | These children get the usual care, information from their parents or doctor before the medical procedure |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education and teaching of coping strategies | Other | the intervention consists of patient education for children, the same content delivered through either an educational game and storytelling |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Through study completion, twice a day of surgery: In the waiting room before anesthesia and just before induction of anesthesia. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brynja Ingadottir, Ph.D | Contact | +3548651817 | brynjain@hi.is | |
| Anna O. Sigurdardottir, Ph.D | Contact | annaos@landspitali.is |
| Name | Affiliation | Role |
|---|---|---|
| Brynja Ingadottir, Ph.D | University of Iceland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laeknastofur Akureyrar | Recruiting | Akureyri | Iceland |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001519 | Behavior |
| D002652 | Child Behavior |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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