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Effect of Premedication Type on Preoperative Anxiety in Children

The Effect of Three Different Interventions on Preoperative Anxiety in Children

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03530670
Acronym
EPPA
Enrollment
138
Registered
2018-05-21
Start date
2018-08-06
Completion date
2019-06-30
Last updated
2019-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preoperative Anxiety

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.

Interventions

0.5 mg/kg oral midazolam administered 20 minutes before anesthesia induction

OTHERFilm http://www.animaturk.com/animasyon/suko-ameliyat-oluyor.

Patients will be watched a short movie (at URL: http://www.animaturk.com/animasyon/suko-ameliyat-oluyor.html#.Wd-YhFu0PIU) 20 minutes before induction.

OTHERPlaying smartphone game

Patients will be played with smartphone (angry birds, subway surfers or snail Bob) 20 minutes before induction

Sponsors

Diskapi Yildirim Beyazit Education and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)

Masking description

single (participant)

Intervention model description

Crossover assignment Effect of pharmacological and nonpharmacological premedication on anxiety

Eligibility

Sex/Gender
ALL
Age
5 Years to 8 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in preoperative anxietyBefore 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

MeasureTime frameDescription
Emergence agitationPostoperative 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.
Mask acceptance score while mask inductionAt anesthesia inductionAnaesthesia 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, struggling

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026