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

Children Under General Anaesthesia Clinical Trial

— TABLET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03531359
• Other study ID #: UV-1-2018
• Status: Recruiting
• Phase: N/A
• Start date: July 4, 2018
• Est. completion date: July 30, 2020

Study information

• Verified date: September 2018
• Source: Universidad de Valparaiso
• Contact: Nathalie López, MD
• Phone: 2364000
• Email: nathalielopez.jq[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: July 30, 2020
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Children Under General Anaesthesia

Intervention

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.

Locations

Country	Name	City	State
Chile	Hospital Carlos Van Buren	Valparaiso

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Valparaiso	Hospital Carlos van Buren Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short version of the modified Yale Preoperative Anxiety Scale(mYPAS-SF)	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.	6 hours
Secondary	Cooperation with the induction	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	30 minuts
Secondary	Changes in postoperative behavior	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	10 days
Secondary	Emergence delirium	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.	1 hour
Secondary	Parents Satisfaction	A gradual scale will be applied to the parents of the patient upon discharge from hospital.	10 minuts