Effect of Premedication Type on Preoperative Anxiety in Children

Preoperative Anxiety Clinical Trial

— EPPA  

Official title:

The Effect of Three Different Interventions on Preoperative Anxiety in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03530670
• Other study ID #: 42/05
• Status: Completed
• Phase: Phase 4
• Start date: August 6, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: July 2019
• Source: Diskapi Yildirim Beyazit Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Preoperative Anxiety

Intervention

Other:
• oral midazolam
0.5 mg/kg oral midazolam administered 20 minutes before anesthesia induction
• Film 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.
• Playing smartphone game
Patients will be played with smartphone (angry birds, subway surfers or snail Bob) 20 minutes before induction

Locations

Country	Name	City	State
Turkey	DiskapiYBERH	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Yildirim Beyazit Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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