NCT03531359

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

Tablet-based Interactive Distraction for the Management of Preoperative Anxiety in Children: A Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: Universidad de Valparaiso · Academic / Other
• Sex: All
• Age: 2 Years – 10 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Children Under General Anaesthesia

Interventions

Type	Name	Description
DEVICE	TIBD	Table-based Interactive Distraction using video-games will be used to prove efficacy in preventing preoperative anxiety.
DRUG	Midazolam	Administration of midazolam oral or rectal 30 minutes to one hour prior to transfer to the theater.

Timeline

• Start date: 2018-07-04
• Primary completion: 2019-06-30
• Completion: 2020-07-30
• First posted: 2018-05-21
• Last updated: 2018-09-05

Locations

1 site across 1 country: Chile