Does Distraction With a Hand Held Video Game Reduce Preoperative and Emergence Anxiety in Children?

Study Overview
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Brief Summary
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Preoperative anxiety is characterized by subjective feelings of tension, apprehension, nervousness and worry. In children, preoperative anxiety is reported to result in postoperative negative psychological effects, including nightmares, eating problems and increased fear of doctors. Previous studies have assessed anxiety in children during the preoperative period and the effects of premedication and parental presence. Midazolzam has been shown to reduce preoperative anxiety in children but post operative recovery maybe delayed for children undergoing a short operative procedure. Distraction may be particularly helpful in children ages 6-12 as these children are curious about their environment. An association between preoperative anxiety and emergence agitation has been suggested. Emergence agitation in children is not well understood but is a frightening experience for child and parent. A previous study demonstrated the efficacy of hand held video games used as an interactive distraction to allay preoperative anxiety. The purpose of this study is to treat preop anxiety with premedication, or video game and to evaluate the impact of these interventions on the incidence and severity of emergence agitation.

Official Title
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Is Preoperative Distraction With a Hand Held Video Game Boy as Effective as Midazolam in Reducing Preoperative Anxiety Levels in Children as Weel as Emergence Agitation?

Conditions
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Pediatric Emergence Agitation and Pain

Intervention / Treatment
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* Drug: Midazolam
* Device: Game Boy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA rating of I-II Mask induction of General Anesthesia Exclusion Criteria: Emergency surgery Children who have developmental disabilities or chronic illness Children who have had repetitive surgeries Children who have excessive anxiety attacks or who are currently on benzopaines

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2. Video Game<br> | Device: Game Boy<br>* Children given video game as a distraction in preop holding and were permitted to continue playing the game in OR during induction<br>* Other names: Nintendo-DS Game Boy;|
| Active Comparator: 1. Midazolam 0.5mg/kg<br> | Drug: Midazolam<br>* Midazolam 0.5mg/kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain |  | on arrival in PACU, at 10 min, at 30 min and 10 minutes prior to discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| emergence agitation |  | on arrival, at 5 minutes and every 10 min for one hour in PACU | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric emergence agitation and pain