Effect of Premedication Type on Preoperative Anxiety in Children
- Conditions
- Preoperative Anxiety
- Interventions
- Other: oral midazolamOther: Playing smartphone game
- Registration Number
- NCT03530670
- Lead Sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Brief Summary
Compare the effects of pharmacological and nonpharmacological premedications on preoperative anxiety and mask acceptance after adenotonsillectomy
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 138
- ASA 1-2
- Elective surgery
- Chronic diseases
- Development disability
- Prematurity
- Neurological diseases
- Psychoactive medication use
- Hearing/visual impairment
- History of surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description oral midazolam (demizolam) oral midazolam 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 playing smartphone game Playing smartphone game 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
- Primary Outcome Measures
Name Time Method Change in preoperative anxiety Before premedications, 20 minutes after premedications, in operating room, at anesthesia induction. 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.
- Secondary Outcome Measures
Name Time Method Mask acceptance score while mask induction At anesthesia 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:
1. Excellent: not scared, accepts mask easily
2. Good: slightly scared of mask, could be calmed down easily
3. Moderate: scared of mask, could not be calmed down
4. Poor: crying, movement of arms and legs, strugglingEmergence agitation 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. 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.
Trial Locations
- Locations (1)
DiskapiYBERH
🇹🇷Ankara, Turkey
DiskapiYBERH🇹🇷Ankara, Turkey