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

Sponsor
University of Medicine and Dentistry of New Jersey (Other)
Overall Status
Completed
CT.gov ID
NCT00932685
Collaborator
Nintendo of North America (Other)
119
Enrollment
1
Location
2
Arms
19
Duration (Months)
6.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
119 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
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?
Study Start Date :
Dec 1, 2005
Actual Primary Completion Date :
Jun 1, 2007
Actual Study Completion Date :
Jul 1, 2007

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. postoperative pain [on arrival in PACU, at 10 min, at 30 min and 10 minutes prior to discharge]

    Secondary Outcome Measures

    1. emergence agitation [on arrival, at 5 minutes and every 10 min for one hour in PACU]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Newark New Jersey United States 07101

    Sponsors and Collaborators

    • University of Medicine and Dentistry of New Jersey
    • Nintendo of North America

    Investigators

    • Principal Investigator: Anuradha Patel, MD, Rutgers, The State University of New Jersey

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00932685
    Other Study ID Numbers:
    • 0120030315A
    First Posted:
    Jul 3, 2009
    Last Update Posted:
    Jul 3, 2009
    Last Verified:
    Jul 1, 2009
    Keywords provided by , ,
    pediatric emergence agitation and pain
    Additional relevant MeSH terms:
    Psychomotor Agitation
    Emergence Delirium
    Midazolam

    Study Results

    No Results Posted as of Jul 3, 2009