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

July 2, 2009 updated by: University of Medicine and Dentistry of New Jersey

Is Preoperative Distraction With a Hand Held Video Game Boy as Effective as Midazolam in Reducing Preoperative Anxiety Levels in Children as Weel as Emergence Agitation?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

119

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Newark, New Jersey, United States, 07101
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2. Video Game
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
Other Names:
  • Nintendo-DS Game Boy
Active Comparator: 1. Midazolam 0.5mg/kg
Drug: Midazolam
Midazolam 0.5mg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
postoperative pain
Time Frame: on arrival in PACU, at 10 min, at 30 min and 10 minutes prior to discharge
on arrival in PACU, at 10 min, at 30 min and 10 minutes prior to discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
emergence agitation
Time Frame: on arrival, at 5 minutes and every 10 min for one hour in PACU
on arrival, at 5 minutes and every 10 min for one hour in PACU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Dentistry of New Jersey

Collaborators

Nintendo of North America

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

July 1, 2009

First Submitted That Met QC Criteria

July 2, 2009

First Posted (Estimate)

July 3, 2009

Study Record Updates

Last Update Posted (Estimate)

July 3, 2009

Last Update Submitted That Met QC Criteria

July 2, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0120030315A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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