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

This study has been completed.
Sponsor:
Collaborator:
Nintendo of North America
Information provided by:
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00932685
First received: July 1, 2009
Last updated: July 2, 2009
Last verified: July 2009

July 1, 2009
July 2, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00932685 on ClinicalTrials.gov Archive Site
emergence agitation [ Time Frame: on arrival, at 5 minutes and every 10 min for one hour in PACU ] [ Designated as safety issue: No ]
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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
119
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
Both
4 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00932685
0120030315A
No
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