Ignite Creation Date:
2024-05-05 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 9:44 AM
Study NCT ID:
NCT00609960
Status:
COMPLETED
Last Update Posted:
2008-02-07
First Post:
2008-01-24
Brief Title:
Clowns as Treatment for Preoperative Anxiety in Children A Randomized Controlled Trial
Sponsor:
Sheba Medical Center
Organization:
Sheba Medical Center
Study Overview
Official Title:
Clowns as Treatment for Preoperative Anxietyin Children- a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2008-01
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:
This study wants to test the hypothesis that trained clowns can reduce anxiety in children undergoing general anesthesia We will compare the effect of the clowns to the commonly used anti-anxiety medication we commonly use
Detailed Description:
The perioperative environment often anxiety-provoking for adults may be quite frightening for children The detrimental effects of preoperative anxiety are not confined to the preoperative period Anxiety during induction of anesthesia is correlated with increased distress early in the postoperative period Holms Knud Kain and maladaptive behavior will follow for the first 2 weeks following surgery in up to 54 of children
Many preoperative systems allow parental pharmacologic and anticipatory interventions to facilitate a relaxed perioperative environment for children Unfortunately scheduling conflicts side effects and limited resources conspire to limit their usefulness For example only 10 of respondents in a recent survey used parental presence during induction of anesthesia PPIA for a majority of their patients This may be due to the belief by some that parental anxiety may in fact increase childrens anxiety Bevans According to the same survey only 50 of children undergoing surgery receive sedating premedication Kain Distraction techniques such as the use of toys or video games may also decrease perioperative anxiety however their effectiveness during induction of anesthesia is not well characterized The efficacy of toys and video games is somewhat dependent upon the child reaching certain developmental milestones Anesthesiologists continue to search for an easy and comprehensive method for anxiety reduction in the pediatric surgical population We propose that specially trained professional clowns may allay preoperative anxiety and result in a smooth anesthetic induction
Many preoperative systems allow parental pharmacologic and anticipatory interventions to facilitate a relaxed perioperative environment for children Unfortunately scheduling conflicts side effects and limited resources conspire to limit their usefulness For example only 10 of respondents in a recent survey used parental presence during induction of anesthesia PPIA for a majority of their patients This may be due to the belief by some that parental anxiety may in fact increase childrens anxiety Bevans According to the same survey only 50 of children undergoing surgery receive sedating premedication Kain Distraction techniques such as the use of toys or video games may also decrease perioperative anxiety however their effectiveness during induction of anesthesia is not well characterized The efficacy of toys and video games is somewhat dependent upon the child reaching certain developmental milestones Anesthesiologists continue to search for an easy and comprehensive method for anxiety reduction in the pediatric surgical population We propose that specially trained professional clowns may allay preoperative anxiety and result in a smooth anesthetic induction
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