Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00609960 |
| Other study ID # |
SHEBA-05-3739-IK-CTIL |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
January 24, 2008 |
| Last updated |
February 6, 2008 |
| Start date |
January 2006 |
| Est. completion date |
January 2007 |
Study information
| Verified date |
January 2008 |
| Source |
Sheba Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Israel: Israeli Health Ministry Pharmaceutical Administration |
| Study type |
Interventional
|
Clinical Trial 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
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 children's 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.
