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

Information source: Rutgers, The State University of New Jersey
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pediatric Emergence Agitation and Pain

Intervention: Midazolam (Drug); Game Boy (Device)

Phase: N/A

Status: Completed

Sponsored by: University of Medicine and Dentistry of New Jersey

Official(s) and/or principal investigator(s):
Anuradha Patel, MD, Principal Investigator, Affiliation: Rutgers, The State University of New Jersey

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.

Clinical Details

Official 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?

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: postoperative pain

Secondary outcome: emergence agitation

Eligibility

Minimum age: 4 Years. Maximum age: 12 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

University Hospital, Newark, New Jersey 07101, United States
Additional Information

Starting date: December 2005
Last updated: July 2, 2009

Page last updated: August 23, 2015

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