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

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-04

Study Completion Date

2020-07-30

Brief Summary

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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.

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Detailed Description

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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

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Children Under General Anaesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Tablet Group: They'll receive a tablet with content adapted to every group. It will be divided into 4 groups (2-4 years, 4-6 years, 6-8 years and 9-10 years). The first one will receive cartoons, the second will also have games; for the other two groups will be assigned appropriate video games depending on the age.

Midazolam group: They'll receive 0,5mg/kg oral or it's equivalent in rectal administration 30 minutes to one hour prior to transfer to the theater. This patients will not be able to have contact with audiovisual devices.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Anxiety will be determined by using a video recording of the child, which will be assessed by psychiatric

Study Groups

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TIBD Tablet-based video distraction

Children will receive of tablet-based interctive games in preoperatory room

Group Type EXPERIMENTAL

TIBD

Intervention Type DEVICE

Table-based Interactive Distraction using video-games will be used to prove efficacy in preventing preoperative anxiety.

Midazolam

Children will be premedicated with usual treatmente (midazolam)

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

Administration of midazolam oral or rectal 30 minutes to one hour prior to transfer to the theater.

Interventions

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TIBD

Table-based Interactive Distraction using video-games will be used to prove efficacy in preventing preoperative anxiety.

Intervention Type DEVICE

Midazolam

Administration of midazolam oral or rectal 30 minutes to one hour prior to transfer to the theater.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

Patients with cognitive impairment or sensory deficit Patients with previous history of major surgery will also be excluded Patients with myastenia "Hard airway" History of paroxystic reaction to benzodiazepines Attentional deficit hyperactivity disorder Sleep aphnea Full stomach Adenotonsillar hypertrophy Respiratory acute infections

Minimum Eligible Age

2 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No