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?

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00932685

Enrollment

119

Registered

2009-07-03

Start date

2005-12-31

Completion date

2007-07-31

Last updated

2009-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Emergence Agitation and Pain

Keywords

pediatric emergence agitation and pain

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.

Interventions

DRUGMidazolam

Midazolam 0.5mg/kg

DEVICEGame Boy

Children given video game as a distraction in preop holding and were permitted to continue playing the game in OR during induction

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

4 Years to 12 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026