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

Sponsor:	University of Medicine and Dentistry New Jersey
Collaborator:	Nintendo of North America
Information provided by:	University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:	NCT00932685

Purpose

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.

Condition	Intervention
Pediatric Emergence Agitation and Pain	Drug: Midazolam Device: Game Boy

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
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?

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

Drug Information available for: Midazolam Midazolam maleate Midazolam hydrochloride

U.S. FDA Resources

Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:

postoperative pain [ Time Frame: on arrival in PACU, at 10 min, at 30 min and 10 minutes prior to discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

emergence agitation [ Time Frame: on arrival, at 5 minutes and every 10 min for one hour in PACU ] [ Designated as safety issue: No ]

Enrollment:	119
Study Start Date:	December 2005
Study Completion Date:	July 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 2. Video Game	Device: Game Boy Children given video game as a distraction in preop holding and were permitted to continue playing the game in OR during induction Other Name: Nintendo-DS Game Boy
Active Comparator: 1. Midazolam 0.5mg/kg	Drug: Midazolam Midazolam 0.5mg/kg

Eligibility

Ages Eligible for Study:	4 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00932685

Locations

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

Sponsors and Collaborators

University of Medicine and Dentistry New Jersey

Nintendo of North America

Investigators

Principal Investigator:

Anuradha Patel, MD

University of Medicine and Dentistry New Jersey

More Information

No publications provided

Responsible Party:	Anuradha Patel, MD, University of Medicine & Dentistry of New Jersy
ClinicalTrials.gov Identifier:	NCT00932685 History of Changes
Other Study ID Numbers:	0120030315A
Study First Received:	July 1, 2009
Last Updated:	July 2, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Medicine and Dentistry New Jersey:

pediatric emergence agitation and pain

Additional relevant MeSH terms:

Psychomotor Agitation
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Midazolam
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents

Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012