Effect of Premedication Type on Preoperative Anxiety in Children

NCT ID: NCT03530670

Last Updated: 2019-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-06

Study Completion Date

2019-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Preoperative Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Crossover assignment Effect of pharmacological and nonpharmacological premedication on anxiety
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
single (participant)

Study Groups

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oral midazolam (demizolam)

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

Group Type ACTIVE_COMPARATOR

oral midazolam

Intervention Type OTHER

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

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

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Playing smartphone game

Intervention Type OTHER

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

Interventions

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oral midazolam

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

Intervention Type OTHER

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.

Intervention Type OTHER

Playing smartphone game

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

Intervention Type OTHER

Other Intervention Names

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demizolam

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diskapi Yildirim Beyazit Education and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Bahar SAKIZCI UYAR

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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DiskapiYBERH

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 33186304 (View on PubMed)

Other Identifiers

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42/05

Identifier Type: -

Identifier Source: org_study_id

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