Effect of Premedication Type on Preoperative Anxiety in Children

Study Overview
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Brief Summary
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Compare the effects of pharmacological and nonpharmacological premedications on preoperative anxiety and mask acceptance after adenotonsillectomy

Detailed Description
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Compare the effects of 0.5 mg/kg oral midazolam, watching film 'Suko is being operated' animation film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor.html#.Wd-YhFu0PIU , playing smartphone game ( subway surfers, snail Bob or angry birds) on preoperative anxiety by m-YPAS in the holding area, in the operating room and while induction of anesthesia. Investigators also evaluated mask acceptance by Mask Acceptance Scale Investigators also evaluated post operative delirium by PAED (postanesthetic emergency delirium) scale at PACU at arrive and every 10 minutes.

Official Title
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The Effect of Three Different Interventions on Preoperative Anxiety in Children

Conditions
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Preoperative Anxiety

Intervention / Treatment
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* Other: oral midazolam
* Other: Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor.
* Other: Playing smartphone game


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA 1-2 Elective surgery Exclusion Criteria: Chronic diseases Development disability Prematurity Neurological diseases Psychoactive medication use Hearing/visual impairment History of surgery

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 8 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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Crossover assignment Effect of pharmacological and nonpharmacological premedication on anxiety
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: oral midazolam (demizolam)<br>To prevent preoperative anxiety patient premedicated by 0.5 mg/kg oral midazolam. In the preoperative holding area, in the operating room, while anesthesia induction by m-YPAS ( modified the Yale Preoperative Anxiety Scale) To make easier anesthesia induction While anesthesia induction by Mask Acceptance Scale | Other: oral midazolam<br>* 0.5 mg/kg oral midazolam administered 20 minutes before anesthesia induction<br>* Other names: demizolam;|
| Active Comparator: http://www.animaturk.com/animasyon/suko-ameliyat-oluyor.<br>To prevent preoperative anxiety by watching a short movie ( at http://www.animaturk.com/animasyon/suko-ameliyat-oluyor.) In the preoperative holding area, in the operating room, while anesthesia induction by m-YPAS ( modified the Yale Preoperative Anxiety Scale) To make easier anesthesia induction While anesthesia induction by Mask Acceptance Scale | Other: Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor.<br>* Patients will be watched a short movie (at URL: http://www.animaturk.com/animasyon/suko-ameliyat-oluyor.html#.Wd-YhFu0PIU) 20 minutes before induction.<br>|
| Active Comparator: playing smartphone game<br>To prevent preoperative anxiety by playing smartphone game ( angry birds, subway surfers, snail Bob) In the preoperative holding area, in the operating room, while anesthesia induction by m-YPAS ( modified the Yale Preoperative Anxiety Scale) To make easier anesthesia induction While anesthesia induction by Mask Acceptance Scale | Other: Playing smartphone game<br>* Patients will be played with smartphone (angry birds, subway surfers or snail Bob) 20 minutes before induction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in preoperative anxiety | Preoperative anxiety will be evaluated by mYPAS (modified Yale Preoperative Anxiety Scale) The mYPAS consists of 22 items in five categories (activity, emotional expressivity, state of arousal, vocalization and use of parents). The highest behavioral level observed in each of the five mYPAS categories is the score for that category. Partial weights were calculated and then added to a total score that ranged from 0 to 100. Cut off points were set to classify: a score of 23.4 to 30 for no anxiety, any score greater than 30 for anxiety. Change in preoperative anxiety from premedication to 20 minutes after premedication, from 20 minutes after premedication to entrance to the operating room at anesthesia induction will be evaluated. | Before premedications, 20 minutes after premedications, in operating room, at anesthesia induction. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergence agitation | Emergence agitation will be evaluated by PAED scale (pediatric anesthesia emergence delirium) The PAED scale involves five items: eye contact, purposeful actions, awareness of the surroundings, restlessness, inconsolability. First three items are scored as follows: 4= not at all, 3= just a little, 2= quite a bit, 1= very much, 0= extremely. Last two items are scored as follows: 0= not at all, 1= just a little, 2= quite a bit, 3= very much, 4= extremely. The scores of each item will summed to obtain a total score. PAED scale score of 10 or more will be defined as emergence delirium. | Postoperative every 10 minutes from entrance to the recovery room until discharge. If there is not a problem, patients are watched 20 minutes in our hospital's recovery room. | 
| Mask acceptance score while mask induction | Anaesthesia will be induced with sevoflurane 8% and N2O 50% in oxygen by mask ventilation. The child's reaction to the mask will be evaluated by a mask acceptance scale. Mask acceptance scale to be used when assessing the child's mask acceptance is: Excellent: not scared, accepts mask easily Good: slightly scared of mask, could be calmed down easily Moderate: scared of mask, could not be calmed down Poor: crying, movement of arms and legs, struggling | At anesthesia induction |