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The Effects of Pre-Operative Magic Tricks Performance on Pre-Operative Anxiety in Children

This study is not yet open for participant recruitment.
Verified by Sheba Medical Center, September 2007

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   

U.S. FDA Resources

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

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • anxiety scores
  • postoperative maladaptive behavior rate

Secondary Outcome Measures:
  • preoperative anxiety scores and rate of postoperative maladaptive behavior

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

Criteria

Inclusion Criteria:

  • age 3-12 years
  • minor surgeries / diagnostic procedures such as endoscopy, biopsy

Exclusion Criteria:

  • children that do not speak Hebrew
  • American Society of Anesthesiologists (ASA) status above II
  • a need for regional anesthesia only
  • a need for an intravenous (IV) cannulation at the induction room or operating room before the induction of anesthesia.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00535457

Contacts
Contact: Ze'ev Shenkman, MD     972-54-447-5617     shenk_sh@smile.net.il    

Locations
Israel
Sheba Medical Center    
      Tel Hashomer, Israel, 52621

Sponsors and Collaborators
Sheba Medical Center

Investigators
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

Keywords provided by Sheba Medical Center:
anxiety  
maladaptive behavior  
anesthesia  
Anxiety before anesthesia and maladaptive behavior after anesthesia.  

ClinicalTrials.gov processed this record on November 18, 2008




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