Clinical trial NCT03531359: Tablet-based Interactive Distraction Preoperative Anxiety in Children: A Randomized Controlled Trial
Official title: Tablet-based Interactive Distraction for the Management of Preoperative Anxiety in Children: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Children Under General Anaesthesia
Lead sponsor: Universidad de Valparaiso
Sponsor class: OTHER
Collaborators: name: Hospital Carlos Van Buren
First posted: 2018-05-21
Enrollment: 112
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Short version of the modified Yale Preoperative Anxiety Scale(mYPAS-SF)
timeFrame: 6 hours
Secondary outcomes:
measure: Cooperation with the induction
timeFrame: 30 minuts
measure: Changes in postoperative behavior
timeFrame: 10 days
measure: Emergence delirium
timeFrame: 1 hour
measure: Parents Satisfaction
timeFrame: 10 minuts
Other outcomes:
Locations:
city: Valparaiso
country: Chile
facility: Hospital Carlos Van Buren
Study officials:
affiliation: Universidad de Valparaíso Chile
name: Nathalie López, MD
role: STUDY_DIRECTOR
affiliation: Universidad de Valparaíso Chile
name: Anamaria Correa, MD
role: PRINCIPAL_INVESTIGATOR
References: