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| Tracking Information | |||||
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| First Received Date ICMJE | September 23, 2007 | ||||
| Last Updated Date | February 4, 2009 | ||||
| Start Date ICMJE | |||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00535457 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
preoperative anxiety scores and rate of postoperative maladaptive behavior | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Effects of Pre-Operative Magic Tricks Performance on Pre-Operative Anxiety in Children | ||||
| Official Title ICMJE | The Effects of Pre-Operative Magic Tricks Performance on Pre-Operative Anxiety in Children | ||||
| Brief Summary | 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. |
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| Detailed Description | |||||
| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Single Blind (Investigator), Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Anxiety | ||||
| Intervention ICMJE | Other: Preoperative Magic Tricks | ||||
| Study Arms / Comparison Groups | Experimental: Children will watch tricks ("magic") before anesthesia induction | ||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Withdrawn | ||||
| Estimated Enrollment ICMJE | 54 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 3 Years to 12 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00535457 | ||||
| Responsible Party | Ze'ev Shenkman, MD, Sheba Medical Center, Department of Anesthesia C | ||||
| Study ID Numbers ICMJE | SHEBA-07-4786-ZS-CTIL | ||||
| Study Sponsor ICMJE | Sheba Medical Center | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Sheba Medical Center | ||||
| Verification Date | February 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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