Effect of Premedication Type on Preoperative Anxiety in Children (EPPA)

Diskapi Yildirim Beyazit Training and Research Hospital

Status and phase: Completed; Phase 4

Conditions: Preoperative Anxiety

Treatments: Other: Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor.; Other: oral midazolam; Other: Playing smartphone game

Study type: Interventional

Funder types: Other

Identifiers

NCT03530670

42/05

Details and patient eligibility

About

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

Full 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.

Enrollment: 138 patients

Sex: All

Ages: 5 to 8 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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138 participants in 3 patient groups

oral midazolam (demizolam)

Active Comparator group

Description:

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

Treatment:

Other: oral midazolam

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

Active Comparator group

Description:

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

Treatment:

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

playing smartphone game

Active Comparator group

Description:

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

Treatment:

Other: Playing smartphone game