Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00176670
Status:
COMPLETED
Last Update Posted:
2016-10-06
First Post:
2005-09-13
Brief Title:
A GameBoy as a Distraction Before Surgery in Children
Sponsor:
University of Medicine and Dentistry of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Is Preoperative Distraction With a Hand Held Game Boy as Effective as Midazolam in Reducing Preoperative Anxiety Levels in Children
Status:
COMPLETED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 childs 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 ie 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
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 ie 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 childs 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 ie 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
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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None