Does Distraction With a Hand Held Video Game Reduce Preoperative and Emergence Anxiety in Children?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-07-31

Brief Summary

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Preoperative anxiety is characterized by subjective feelings of tension, apprehension, nervousness and worry. In children, preoperative anxiety is reported to result in postoperative negative psychological effects, including nightmares, eating problems and increased fear of doctors. Previous studies have assessed anxiety in children during the preoperative period and the effects of premedication and parental presence. Midazolzam has been shown to reduce preoperative anxiety in children but post operative recovery maybe delayed for children undergoing a short operative procedure. Distraction may be particularly helpful in children ages 6-12 as these children are curious about their environment. An association between preoperative anxiety and emergence agitation has been suggested. Emergence agitation in children is not well understood but is a frightening experience for child and parent. A previous study demonstrated the efficacy of hand held video games used as an interactive distraction to allay preoperative anxiety. The purpose of this study is to treat preop anxiety with premedication, or video game and to evaluate the impact of these interventions on the incidence and severity of emergence agitation.

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Detailed Description

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Conditions

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Pediatric Emergence Agitation and Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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2. Video Game

Group Type ACTIVE_COMPARATOR

Game Boy

Intervention Type DEVICE

Children given video game as a distraction in preop holding and were permitted to continue playing the game in OR during induction

1. Midazolam 0.5mg/kg

Group Type ACTIVE_COMPARATOR

Midazolam

Intervention Type DRUG

Midazolam 0.5mg/kg

Interventions

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Midazolam

Midazolam 0.5mg/kg

Intervention Type DRUG

Game Boy

Children given video game as a distraction in preop holding and were permitted to continue playing the game in OR during induction

Intervention Type DEVICE

Other Intervention Names

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Nintendo-DS Game Boy

Eligibility Criteria

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Inclusion Criteria

* ASA rating of I-II Mask induction of General Anesthesia

Exclusion Criteria

* Emergency surgery Children who have developmental disabilities or chronic illness Children who have had repetitive surgeries Children who have excessive anxiety attacks or who are currently on benzopaines

Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No