Tablet-based Interactive Distraction Preoperative Anxiety in Children: A Randomized Controlled Trial
- Registration Number
- NCT03531359
- Lead Sponsor
- Universidad de Valparaiso
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 112
Children aged 2-10 years, under major surgery ambulatory program at Hospital Carlos Van Buren, with no contraindication for the use of midazolam.
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TIBD Tablet-based video distraction TIBD Children will receive of tablet-based interctive games in preoperatory room Midazolam Midazolam Children will be premedicated with usual treatmente (midazolam)
- Primary Outcome Measures
Name Time Method Short version of the modified Yale Preoperative Anxiety Scale(mYPAS-SF) 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 Outcome Measures
Name Time Method Changes in postoperative behavior 10 days The Post Behavioral Behavior Change Questionnaire (PHBQ) will be applied at the postoperative surgical control (7-10 days after the intervention). This survey will be applied by people trained by the hospital's pediatric psychiatry team The higher the score, the more behavioral changes in the postoperative period
Emergence delirium 1 hour In the post-anesthesia recovery unit, the Emergency Delirium Scale for Pediatric Anesthesia (PAED) will be applied every 15 minutes during the first 30 minutes of their stay in the unit. Score goes from 0 to 20. Scores greater than 10 is considered as delirium.
Parents Satisfaction 10 minuts A gradual scale will be applied to the parents of the patient upon discharge from hospital.
Cooperation with the induction 30 minuts Scale with 10 items, 1 point for each one. 0 points shows an induction with perfect cooperation.
This scale will be applied at the moment of the induction by the anesthesiologist
Trial Locations
- Locations (1)
Hospital Carlos Van Buren
🇨🇱Valparaiso, Chile