Tablet-based Interactive Distraction Preoperative Anxiety in Children: A Randomized Controlled Trial

Study Overview
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Brief Summary
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Children develop anxiety during the induction of anaesthesia and video-games might reduce or alleviate it. The investigators intend to conduct a clinical trial to study the effect of tablet-based interctive games on alleviating preoperative anxiety.

Detailed Description
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It is estimated that 50% of children may suffer preoperative anxiety. They have a higher risk of generating postanesthetic delirium and behavioral changes in the postoperative period up to 67% of cases. For the management of preoperative anxiety there are pharmacological and non-pharmacological treatments. Within the first group there's the use of benzodiazepines of short half life like midazolam, however, the use of this medication is not exempt of risks such as paradox reactions, respiratory depression, among others. This is why the non pharmacological mesures have taken force and every day there is more evidence regarding its effectiveness. There are no reports in Chile or latin america regarding the use of this tools, this is why the investigators designed this study to prove the effectiveness of audiovisual distraction measures in reducing preparatory anxiety compared to premeditation with midazolam.

Official Title
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Tablet-based Interactive Distraction for the Management of Preoperative Anxiety in Children: A Randomized Controlled Trial

Conditions
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Children Under General Anaesthesia

Intervention / Treatment
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* Device: TIBD
* Drug: Midazolam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged 2-10 years, under major surgery ambulatory program at Hospital Carlos Van Buren, with no contraindication for the use of midazolam. Exclusion Criteria: Patients with cognitive impairment or sensory deficit Patients with previous history of major surgery will also be excluded Patients with myastenia Hard airway History of paroxystic reaction to benzodiazepines Attentional deficit hyperactivity disorder Sleep aphnea Full stomach Adenotonsillar hypertrophy Respiratory acute infections

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 10 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Tablet Group: They'll receive a tablet with content adapted to every group. It will be divided into 4 groups (2-4 years, 4-6 years, 6-8 years and 9-10 years). The first one will receive cartoons, the second will also have games; for the other two groups will be assigned appropriate video games depending on the age. Midazolam group: They'll receive 0,5mg/kg oral or it's equivalent in rectal administration 30 minutes to one hour prior to transfer to the theater. This patients will not be able to have contact with audiovisual devices.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TIBD Tablet-based video distraction<br>Children will receive of tablet-based interctive games in preoperatory room | Device: TIBD<br>* Table-based Interactive Distraction using video-games will be used to prove efficacy in preventing preoperative anxiety.<br>|
| Active Comparator: Midazolam<br>Children will be premedicated with usual treatmente (midazolam) | Drug: Midazolam<br>* Administration of midazolam oral or rectal 30 minutes to one hour prior to transfer to the theater.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short version of the modified Yale Preoperative Anxiety Scale(mYPAS-SF) | Difference between the measurement of the mYPAS-SF applied in the preoperative time and prior to induction. The scale has 18 items in 4 categories. Maximum score is 100 points. The higher the score, the greater the anxiety. | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cooperation with the induction | Scale with 10 items, 1 point for each one. 0 points shows an induction with perfect cooperation. This scale will be applied at the moment of the induction by the anesthesiologist | 30 minuts | 
| Changes in postoperative behavior | The Post Behavioral Behavior Change Questionnaire (PHBQ) will be applied at the postoperative surgical control (7-10 days after the intervention). This survey will be applied by people trained by the hospital's pediatric psychiatry team The higher the score, the more behavioral changes in the postoperative period | 10 days | 
| Emergence delirium | In the post-anesthesia recovery unit, the Emergency Delirium Scale for Pediatric Anesthesia (PAED) will be applied every 15 minutes during the first 30 minutes of their stay in the unit. Score goes from 0 to 20. Scores greater than 10 is considered as delirium. | 1 hour | 
| Parents Satisfaction | A gradual scale will be applied to the parents of the patient upon discharge from hospital. | 10 minuts |