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

NCT00932685 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2009-07-03

No results posted yet for this study

Summary

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.

Conditions

  • Pediatric Emergence Agitation and Pain

Interventions

DRUG

Midazolam

Midazolam 0.5mg/kg

DEVICE

Game Boy

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

Sponsors & Collaborators

  • Nintendo of North America

    collaborator UNKNOWN

  • University of Medicine and Dentistry of New Jersey

    lead OTHER

Principal Investigators

  • Anuradha Patel, MD · Rutgers, The State University of New Jersey

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2007-06-30
Completion
2007-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00932685 on ClinicalTrials.gov