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

Not Applicable

Completed

• Conditions: Pediatric Emergence Agitation and Pain
• Interventions: Device: Game Boy; Drug: Midazolam

• Registration Number: NCT00932685
• Lead Sponsor: University of Medicine and Dentistry of New Jersey

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Primary Completion: 2007-06
• Study Completion: 2007-07
• Status Verified: 2009-07
• Study First Submitted: 2009-07-01
• Study First Submitted QC: 2009-07-02
• Last Update Submitted: 2009-07-02
• Study First Posted: 2009-07-03
• Last Update Posted: 2009-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2. Video Game	Game Boy	-
1. Midazolam 0.5mg/kg	Midazolam	-

Primary Outcome Measures

Name	Time	Method
postoperative pain	on arrival in PACU, at 10 min, at 30 min and 10 minutes prior to discharge

Secondary Outcome Measures

Name	Time	Method
emergence agitation	on arrival, at 5 minutes and every 10 min for one hour in PACU

Trial Locations

Locations (1)

University Hospital; 🇺🇸 Newark, New Jersey, United States