Effect of Premedication Type on Preoperative Anxiety in Children

NCT03530670 | Completed Phase 4 DMC

• 1 other identifier: 42/05
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Preoperative Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Emergence 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.

• Mask acceptance score while mask induction

  At anesthesia induction

Study Arms (3)

oral midazolam (demizolam)

ACTIVE COMPARATOR

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

Other: oral midazolam

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

ACTIVE COMPARATOR

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

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

playing smartphone game

ACTIVE COMPARATOR

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

Other: Playing smartphone game

Interventions

oral midazolam OTHER

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

Also known as: demizolam

oral midazolam (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.

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

Playing smartphone game OTHER

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

playing smartphone game

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASA 1-2
• Elective surgery

You may not qualify if:

• Chronic diseases
• Development disability
• Prematurity
• Neurological diseases
• Psychoactive medication use
• Hearing/visual impairment
• History of surgery

Sponsors & Collaborators

• Diskapi Yildirim Beyazit Education and Research Hospital: lead

Study Sites (1)

DiskapiYBERH

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

• Sakizci Uyar B, Polat R, Bolat M, Donmez A. Which is good for pre-operative anxiety? Midazolam, video games or teaching with cartoons: A randomised trial. Eur J Anaesthesiol. 2021 Jul 1;38(7):744-750. doi: 10.1097/EJA.0000000000001384.

  PMID: 33186304 DERIVED

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single (participant)
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Crossover assignment Effect of pharmacological and nonpharmacological premedication on anxiety

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: May 21, 2018
• Study Start: August 6, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: July 26, 2019

Record last verified: 2019-07

Locations

TU (1)