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
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