A GameBoy as a Distraction Before Surgery in Children

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Anxiety	Drug: midazolam or GameBoy or parental presence	Phase 2

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.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Enrollment :	158 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Is Preoperative Distraction With a Hand Held Game Boy as Effective as Midazolam in Reducing Preoperative Anxiety Levels in Children?
Study Start Date :	January 2004
Actual Primary Completion Date :	April 2006
Actual Study Completion Date :	April 2006

Arms and Interventions

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Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Yale Preoperative Anxiety Scale

Secondary Outcome Measures :

1. 10-14 days post hospitalization behavioral questionnaire

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	4 Years to 16 Years (Child)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

University of Medicine and Dentistry of New Jersey

Investigators

Principal Investigator:	Anuradha Patel, MD	Rutgers, The State University of New Jersey

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Anuradha patel, MD, UMDNJ-Newark
ClinicalTrials.gov Identifier:	NCT00176670 History of Changes
Other Study ID Numbers:	0120030315
First Posted:	September 15, 2005
Last Update Posted:	October 6, 2016
Last Verified:	June 2008
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Rutgers, The State University of New Jersey:

presurgical anxiety, children,

Additional relevant MeSH terms:

Anxiety Disorders; Mental Disorders; Midazolam; Adjuvants, Anesthesia; Hypnotics and Sedatives; Central Nervous System Depressants; Physiological Effects of Drugs; Anti-Anxiety Agents; Tranquilizing Agents	Psychotropic Drugs; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; GABA Modulators; GABA Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action