Tablet-based Interactive Distraction for the Management of Preoperative Anxiety in Children: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Midazolam
- Conditions
- Children Under General Anaesthesia
- Sponsor
- Universidad de Valparaiso
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- Short version of the modified Yale Preoperative Anxiety Scale(mYPAS-SF)
- Last Updated
- 7 years ago
Overview
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.
Investigators
Nathalie Lopez
Principal Investigator
Universidad de Valparaiso
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
Arms & Interventions
Midazolam
Children will be premedicated with usual treatmente (midazolam)
Intervention: Midazolam
TIBD Tablet-based video distraction
Children will receive of tablet-based interctive games in preoperatory room
Intervention: TIBD
Outcomes
Primary Outcomes
Short version of the modified Yale Preoperative Anxiety Scale(mYPAS-SF)
Time Frame: 6 hours
Difference between the measurement of the mYPAS-SF applied in the preoperative time and prior to induction. The scale has 18 items in 4 categories. Maximum score is 100 points. The higher the score, the greater the anxiety.
Secondary Outcomes
- Changes in postoperative behavior(10 days)
- Emergence delirium(1 hour)
- Parents Satisfaction(10 minuts)
- Cooperation with the induction(30 minuts)