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Completed

NCT Number: NCT03530670

Effect of Premedication Type on Preoperative Anxiety in Children

Compare the effects of pharmacological and nonpharmacological premedications on preoperative anxiety and mask acceptance after adenotonsillectomy

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Key information

Conditions

Preoperative Anxiety

Age range

5 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

DiskapiYBERH

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oral midazolam

Other

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

Other names: demizolam

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

Other

Patients will be watched a short movie (at URL:

http://www.animaturk.com/animasyon/suko-ameliyat-oluyor.html#.Wd-YhFu0PIU) 20 minutes before induction.

Playing smartphone game

Other

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

Primary outcomes

  1. Change in preoperative anxiety

    Time frame: 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 outcomes

  1. Emergence agitation

    Time frame: 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.

  2. Mask acceptance score while mask induction

    Time frame: 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:

    • 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

Sponsors and collaborators

Lead sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

Other Gov

Registry information

Official study title

The Effect of Three Different Interventions on Preoperative Anxiety in Children

Acronym: EPPA

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 21, 2018
Registry last updated
Jul 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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