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A GameBoy as a Distraction Before Surgery in Children

Primary Purpose

Anxiety

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
midazolam or GameBoy or parental presence
Sponsored by
University of Medicine and Dentistry of New Jersey
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety focused on measuring presurgical anxiety, children,

Eligibility Criteria

4 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female patients ages 4 years to 16 years 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. Families who do not have a telephone

Sites / Locations

  • New Jersey Medical School

Outcomes

Primary Outcome Measures

Yale Preoperative Anxiety Scale

Secondary Outcome Measures

10-14 days post hospitalization behavioral questionnaire

Full Information

First Posted
September 13, 2005
Last Updated
October 4, 2016
Sponsor
University of Medicine and Dentistry of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT00176670
Brief Title
A GameBoy as a Distraction Before Surgery in Children
Official Title
Is Preoperative Distraction With a Hand Held Game Boy as Effective as Midazolam in Reducing Preoperative Anxiety Levels in Children?
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Medicine and Dentistry of New Jersey

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, separation anxiety, eating problems and increased fear of doctors. Anxiety in children can be expressed in many forms. Many children look scared, become agitated, breathe deeply, tremble, and stop talking or playing and start to cry. They may unexpectedly urinate or may actively attempt to escape from the medical personnel. These reactions reflect the child's fear of separation from the parents, as well as loss of control, unfamiliar routines, instruments and hospital procedures [1]. Previous studies have assessed anxiety in children during the preoperative period and the effects of premedication and parental presence during induction of anesthesia (PPIA) [2]. Midazolam has been proven to reduce preoperative anxiety in children [3]. Side effects related to oral midazolam administered to healthy children are minimal and the drug can be reversed with flumazenil but post operative recovery may be delayed in those children undergoing a short surgical procedure. It is the experience of the investigator that there are some children who have such low levels of anxiety they do not require any intervention Distraction may be particularly helpful in children ages 6-12 as these children may not receive preoperative medication due to their curiosity about the environment. Previous studies regarding distraction therapy have focused on the parent either blowing bubbles or reading to a child [4]. Studies where the child is actively engaged in a distraction activity have not been documented. The purpose of this investigation is to determine whether in the presence of a parent an interactive distraction intervention, i.e. Game Boy which is a hand held video game, is as effective as preoperative Midazolam in reducing preoperative anxiety. This study may help in the search for a low cost and easy to implement method of reducing anxiety for children undergoing surgery.
Detailed Description
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, separation anxiety, eating problems and increased fear of doctors. Anxiety in children can be expressed in many forms. Many children look scared, become agitated, breathe deeply, tremble, and stop talking or playing and start to cry. They may unexpectedly urinate or may actively attempt to escape from the medical personnel. These reactions reflect the child's fear of separation from the parents, as well as loss of control, unfamiliar routines, instruments and hospital procedures [1]. Previous studies have assessed anxiety in children during the preoperative period and the effects of premedication and parental presence during induction of anesthesia (PPIA) [2]. Midazolam has been proven to reduce preoperative anxiety in children [3]. Side effects related to oral midazolam administered to healthy children are minimal and the drug can be reversed with flumazenil but post operative recovery may be delayed in those children undergoing a short surgical procedure. It is the experience of the investigator that there are some children who have such low levels of anxiety they do not require any intervention Distraction may be particularly helpful in children ages 6-12 as these children may not receive preoperative medication due to their curiosity about the environment. Previous studies regarding distraction therapy have focused on the parent either blowing bubbles or reading to a child [4]. Studies where the child is actively engaged in a distraction activity have not been documented. The purpose of this investigation is to determine whether in the presence of a parent an interactive distraction intervention, i.e. Game Boy which is a hand held video game, is as effective as preoperative Midazolam in reducing preoperative anxiety. This study may help in the search for a low cost and easy to implement method of reducing anxiety for children undergoing surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
presurgical anxiety, children,

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
158 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
midazolam or GameBoy or parental presence
Primary Outcome Measure Information:
Title
Yale Preoperative Anxiety Scale
Secondary Outcome Measure Information:
Title
10-14 days post hospitalization behavioral questionnaire

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients ages 4 years to 16 years 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. Families who do not have a telephone
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
New Jersey Medical School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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A GameBoy as a Distraction Before Surgery in Children

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