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NCT00176670 · ClinicalTrials.gov registry record · Phase 2
A GameBoy as a Distraction Before Surgery in Children
A Phase 2 study, sponsored by University of Medicine and Dentistry of New Jersey.
- Completed
- Registry status
- Phase 2
- Development phase
- 158
- Enrollment target
NCT00176670 is a Phase 2 study that has completed, run by University of Medicine and Dentistry of New Jersey. The registered enrollment target is 158 participants.
The verdict
NCT00176670, a Phase 2 study, has completed, sponsored by University of Medicine and Dentistry of New Jersey.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 158 participants
- Enrollment target
Study 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. T
Interventions
- DRUG midazolam or GameBoy or parental presence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2004-01 |
| Est. Completion | 2006-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00176670
The ClinicalTrials.gov registry entry for NCT00176670 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 158 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Medicine and Dentistry of New Jersey, which has 88 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which midazolam or GameBoy or parental presence is the first listed.
NCT00176670 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00176670 about?
NCT00176670 is a clinical study titled "A GameBoy as a Distraction Before Surgery in Children". 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 docto...
What is the current status of trial NCT00176670?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 158 participants. The study started on 2004-01. Estimated completion is 2006-04.
What interventions are being tested in trial NCT00176670?
The interventions under investigation include: midazolam or GameBoy or parental presence (DRUG).
Who is sponsoring clinical trial NCT00176670?
This trial is sponsored by University of Medicine and Dentistry of New Jersey, which has 88 total clinical trials registered on ClinicalTrials.gov.
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