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A GameBoy as a Distraction Before Surgery in Children

This study has been completed.

Sponsored by: University of Medicine and Dentistry New Jersey
Information provided by: University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier: NCT00176670
  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, 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.


Condition Intervention Phase
Anxiety
Drug: midazolam or GameBoy or parental presence
Phase II

MedlinePlus related topics:   Anxiety   

Drug Information available for:   Midazolam    Midazolam hydrochloride    Midazolam maleate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Is Preoperative Distraction With a Hand Held Game Boy as Effective as Midazolam in Reducing Preoperative Anxiety Levels in Children?

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

Primary Outcome Measures:
  • Yale Preoperative Anxiety Scale

Secondary Outcome Measures:
  • 10-14 days post hospitalization behavioral questionnaire

Estimated Enrollment:   158
Study Start Date:   January 2004
Study Completion Date:   April 2006
Primary Completion Date:   April 2006 (Final data collection date for primary outcome measure)

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.

  Eligibility
Ages Eligible for Study:   4 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  1. Male or female patients ages 4 years to 16 years
  2. ASA rating of I-II
  3. Mask induction of general anesthesia

Exclusion Criteria:

  1. Emergency Surgery
  2. Children who have developmental disabilities or chronic illness
  3. Children who have had repetitive surgeries.
  4. Families who do not have a telephone
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00176670

Locations
United States, New Jersey
New Jersey Medical School    
      Newark, New Jersey, United States, 07103

Sponsors and Collaborators
University of Medicine and Dentistry New Jersey

Investigators
Principal Investigator:     Anuradha Patel, MD     University of Medicine and Dentistry New Jersey    
  More Information


Responsible Party:   UMDNJ-Newark ( Anuradha patel, MD )
Study ID Numbers:   0120030315
First Received:   September 13, 2005
Last Updated:   June 23, 2008
ClinicalTrials.gov Identifier:   NCT00176670
Health Authority:   United States: Food and Drug Administration

Keywords provided by University of Medicine and Dentistry New Jersey:
presurgical anxiety, children,  

Study placed in the following topic categories:
Midazolam

Additional relevant MeSH terms:
Anesthetics, Intravenous
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Anesthetics
Pharmacologic Actions
Adjuvants, Anesthesia
Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
GABA Agents
Anti-Anxiety Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 23, 2008




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