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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00932685
Recruitment Status : Completed
First Posted : July 3, 2009
Last Update Posted : July 3, 2009
Nintendo of North America
Information provided by:
Rutgers, The State University of New Jersey

July 1, 2009
July 3, 2009
July 3, 2009
December 2005
June 2007   (Final data collection date for primary outcome measure)
postoperative pain [ Time Frame: on arrival in PACU, at 10 min, at 30 min and 10 minutes prior to discharge ]
Same as current
No Changes Posted
emergence agitation [ Time Frame: on arrival, at 5 minutes and every 10 min for one hour in PACU ]
Same as current
Not Provided
Not Provided
Does Distraction With a Hand Held Video Game Reduce Preoperative and Emergence Anxiety in Children?
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.
Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Pediatric Emergence Agitation and Pain
  • 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
    Other Name: Nintendo-DS Game Boy
  • Active Comparator: 2. Video Game
    Intervention: Device: Game Boy
  • Active Comparator: 1. Midazolam 0.5mg/kg
    Intervention: Drug: Midazolam
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
July 2007
June 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
4 Years to 12 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Anuradha Patel, MD, University of Medicine & Dentistry of New Jersy
University of Medicine and Dentistry of New Jersey
Nintendo of North America
Principal Investigator: Anuradha Patel, MD Rutgers, The State University of New Jersey
Rutgers, The State University of New Jersey
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP