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OpenTrials
Completed

NCT Number: NCT00932685

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

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.

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Key information

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Newark, New Jersey, 07101, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

midazolam

Drug

Midazolam 0.5mg/kg

Game Boy

Device

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

Primary outcomes

  1. postoperative pain

    Time frame: on arrival in PACU, at 10 min, at 30 min and 10 minutes prior to discharge

Secondary outcomes

  1. emergence agitation

    Time frame: on arrival, at 5 minutes and every 10 min for one hour in PACU

Sponsors and collaborators

Lead sponsor

University of Medicine and Dentistry of New Jersey

Other

Collaborators

  • Nintendo of North America

Registry information

Official study 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?

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Jul 3, 2009
Registry last updated
Jul 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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