Does Distraction With a Hand Held Video Game Reduce Preoperative and Emergence Anxiety in Children?
Primary Purpose
Pediatric Emergence Agitation and Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Midazolam
Game Boy
Sponsored by
About this trial
This is an interventional prevention trial for Pediatric Emergence Agitation and Pain focused on measuring pediatric emergence agitation and pain
Eligibility 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
Sites / Locations
- University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
2. Video Game
1. Midazolam 0.5mg/kg
Arm Description
Outcomes
Primary Outcome Measures
postoperative pain
Secondary Outcome Measures
emergence agitation
Full Information
NCT ID
NCT00932685
First Posted
July 1, 2009
Last Updated
July 2, 2009
Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
Nintendo of North America
1. Study Identification
Unique Protocol Identification Number
NCT00932685
Brief Title
Does Distraction With a Hand Held Video Game Reduce Preoperative and Emergence Anxiety in Children?
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 Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
Nintendo of North America
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Emergence Agitation and Pain
Keywords
pediatric emergence agitation and pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2. Video Game
Arm Type
Active Comparator
Arm Title
1. Midazolam 0.5mg/kg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
Midazolam 0.5mg/kg
Intervention Type
Device
Intervention Name(s)
Game Boy
Other Intervention Name(s)
Nintendo-DS Game Boy
Intervention Description
Children given video game as a distraction in preop holding and were permitted to continue playing the game in OR during induction
Primary Outcome Measure Information:
Title
postoperative pain
Time Frame
on arrival in PACU, at 10 min, at 30 min and 10 minutes prior to discharge
Secondary Outcome Measure Information:
Title
emergence agitation
Time Frame
on arrival, at 5 minutes and every 10 min for one hour in PACU
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anuradha Patel, MD
Organizational Affiliation
Rutgers, The State University of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07101
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Does Distraction With a Hand Held Video Game Reduce Preoperative and Emergence Anxiety in Children?
We'll reach out to this number within 24 hrs