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| Sponsored by: |
Sheba Medical Center |
| Information provided by: | Sheba Medical Center |
| ClinicalTrials.gov Identifier: | NCT00535457 |
Purpose
It is not uncommon for children to undergo surgery. Surgery is a threatening event that is composed of various stress-provoking stimuli. Pre-operative anxiety is a common emotional response among operated children and their parents. In the current study we are going to examine if tricks done by the anesthesiologist before anesthetic induction are equally as effective as oral midazolam premedication in the reduction of pre-operative anxiety in children before and after surgery. A successful anxiety reduction may be advantageous over pharmacological premedication by cost reduction, a possibly shorter post anesthesia care stay and by reducing postoperative maladaptive behavior rate.
Study hypothesis: 1. similar anxiety scores will be observed in children that will watch their anesthesiologist performing tricks and in those who will receive oral midazolam premedication but no tricks.
2. Similar rates of postoperative maladaptive behavior will be found in children that that will see tricks and in those that will receive midazolam premedication.
| Condition | Intervention | Phase |
|
Anxiety |
Other: Preoperative Magic Tricks |
Phase I |
| MedlinePlus related topics: | Anesthesia Anxiety |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Single Blind (Investigator), Parallel Assignment, Efficacy Study |
| Official Title: | The Effects of Pre-Operative Magic Tricks Performance on Pre-Operative Anxiety in Children |
| Arms | Assigned Interventions |
|
1: Experimental
Children will watch tricks ("magic") before anesthesia induction
|
Other: Preoperative Magic Tricks
Watching "magic"; Study patients will watch the anesthesiologist performing tricks ("magic") before anesthesia induction.
|
Eligibility
| Ages Eligible for Study: | 3 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Ze'ev Shenkman, MD | 972-54-447-5617 | shenk_sh@smile.net.il |
| Israel | |||||
| Sheba Medical Center | |||||
| Tel Hashomer, Israel, 52621 | |||||
| Sheba Medical Center |
| Principal Investigator: | Ze'ev Shenkman, MD | Sheba Medical Center |
More Information
| Study ID Numbers: | SHEBA-07-4786-ZS-CTIL |
| First Received: | September 23, 2007 |
| Last Updated: | September 25, 2007 |
| ClinicalTrials.gov Identifier: | NCT00535457 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
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