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

NCT03531359 | Unknown

• 1 other identifier: UV-1-2018
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Children Under General Anaesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Cooperation with the induction

  30 minuts

• Changes in postoperative behavior

  10 days

• Emergence delirium

  1 hour

• Parents Satisfaction

  10 minuts

Study Arms (2)

TIBD Tablet-based video distraction

EXPERIMENTAL

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

Device: TIBD

Midazolam

ACTIVE COMPARATOR

Children will be premedicated with usual treatmente (midazolam)

Drug: Midazolam

Interventions

TIBD DEVICE

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

TIBD Tablet-based video distraction

Midazolam DRUG

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

Midazolam

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Valparaiso: lead
• Hospital Carlos Van Buren: collaborator

Study Sites (1)

Hospital Carlos Van Buren

Valparaíso, 2341131, Chile

RECRUITING

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Nathalie López, MD

  Universidad de Valparaíso Chile

  STUDY DIRECTOR

• Anamaria Correa, MD

  Universidad de Valparaíso Chile

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie López, MD

CONTACT

2364000; nathalielopez.jq@gmail.com

Anamaria Correa, MD

CONTACT

2364000; anamaria.correa@uv.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Anxiety will be determined by using a video recording of the child, which will be assessed by psychiatric
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: May 21, 2018
• Study Start: July 4, 2018
• Primary Completion: June 30, 2019
• Study Completion: July 30, 2020
• Last Updated: September 5, 2018

Record last verified: 2018-09

Locations

CL (1)