Tablet-based Interactive Distraction Preoperative Anxiety in Children: A Randomized Controlled Trial

Last updated: September 2, 2018
Sponsor: Universidad de Valparaiso
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03531359
UV-1-2018
  • Ages 2-10
  • All Genders

Study Summary

Children develop anxiety during the induction of anaesthesia and video-games might reduce or alleviate it. The investigators intend to conduct a clinical trial to study the effect of tablet-based interctive games on alleviating preoperative anxiety.

Eligibility Criteria

Inclusion

Inclusion Criteria: Children aged 2-10 years, under major surgery ambulatory program at Hospital Carlos VanBuren, with no contraindication for the use of midazolam.

Exclusion

Exclusion Criteria: Patients with cognitive impairment or sensory deficit Patients with previous history ofmajor surgery will also be excluded Patients with myastenia "Hard airway" History ofparoxystic reaction to benzodiazepines Attentional deficit hyperactivity disorder Sleepaphnea Full stomach Adenotonsillar hypertrophy Respiratory acute infections

Study Design

Total Participants: 112
Study Start date:
July 04, 2018
Estimated Completion Date:
July 30, 2020

Study Description

It is estimated that 50% of children may suffer preoperative anxiety. They have a higher risk of generating postanesthetic delirium and behavioral changes in the postoperative period up to 67% of cases.

For the management of preoperative anxiety there are pharmacological and non-pharmacological treatments. Within the first group there's the use of benzodiazepines of short half life like midazolam, however, the use of this medication is not exempt of risks such as paradox reactions, respiratory depression, among others. This is why the non pharmacological mesures have taken force and every day there is more evidence regarding its effectiveness.

There are no reports in Chile or latin america regarding the use of this tools, this is why the investigators designed this study to prove the effectiveness of audiovisual distraction measures in reducing preparatory anxiety compared to premeditation with midazolam.

Connect with a study center

  • Hospital Carlos Van Buren

    Valparaiso, 2341131
    Chile

    Active - Recruiting

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