CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 84 enrolled
Drug / intervention
info +1 morebehavioral
Likely dose
Not stated in record
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Search/NCT02246062
NCT02246062N/ACompleted

Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children

Faculdade de Ciências Médicas da Santa Casa de São Paulo·interventional·Posted Sep 22, 2014·Updated Jan 7, 2016

In Brief

A clinical study evaluating info and smartphone for Anxiety State and Parent-Child Relations. Completed, enrolled 84 participants across 1 site.

Detailed Summary

Background: Preoperative Anxiety is a negative factor in anesthetic and surgical experience. Among the strategies for reducing children's anxiety, non-pharmacological strategies are as important as the pharmacological ones, but their its validity is still controversial. Objectives: The aim of this study is to verify if the information provided to relatives as well as and smartphone application provided to children interferes in prevalence and level of child preoperative anxiety. Methods: Eighty four children, 4-8 years old, ASA I, II and III, undergoing elective surgical procedures and their relatives are randomly allocated into four groups: control group (CG) where the relative received conventional information about anesthesia; info group (IG), relative received an information leaflet about anesthesia; device group (DG), relative received only conventional verbal information and the child received smartphone application immediately before entering the operating room; device and info group (DIG) relative received a leaflet containing information and the child received smartphone application. Children's anxiety will be assessed using the modified Yale Preoperative Anxiety Scale (m-YPAS) on three occasions: at the ward (W), surgical theater in the waiting room (WR) and at the operating room (OR). Statistics analysis will employ by Kruskall-Wallis and Mann-Whitney tests for prevalence and level of anxiety in the groups.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 22, 2014
Enrollment StartJun 1, 2013
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 11.8 years ago

Interventions

infobehavioral

the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.

smartphonebehavioral

the child received smartphone application immediately before entering the operating room