Does Distraction With a Hand Held Video Game Reduce Preoperative and Emergence Anxiety in Children?
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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? |
- 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 ]
- 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 |
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| United States, New Jersey | |
| University Hospital | |
| Newark, New Jersey, United States, 07101 | |
| 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 June 17, 2013