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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00535457
First received: September 23, 2007
Last updated: June 7, 2012
Last verified: June 2012

September 23, 2007
June 7, 2012
Not Provided
Not Provided
  • anxiety scores [ Time Frame: Technical problems with video-taping of the patients still avoid us from recruiting patients. Therefore, the time frame of the study is still unclear tome. ] [ Designated as safety issue: No ]
  • postoperative maladaptive behavior rate
  • anxiety scores
  • postoperative maladaptive behavior rate
Complete list of historical versions of study NCT00535457 on ClinicalTrials.gov Archive Site
preoperative anxiety scores and rate of postoperative maladaptive behavior
Same as current
Not Provided
Not Provided
 
The Effects of Pre-operative Magic Tricks Performance on Pre-operative Anxiety in Children
The Effects of Pre-operative Magic Tricks Performance on Pre-operative Anxiety in Children

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Anxiety
Other: Preoperative Magic Tricks
Watching "magic"; Study patients will watch the anesthesiologist performing tricks ("magic") before anesthesia induction.
Experimental: 1
Children will watch tricks ("magic") before anesthesia induction
Intervention: Other: Preoperative Magic Tricks
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
Not Provided

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.
Both
3 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00535457
SHEBA-07-4786-ZS-CTIL
No
Ze'ev Shenkman, MD, Sheba Medical Center, Department of Anesthesia C
Sheba Medical Center
Not Provided
Principal Investigator: Ze'ev Shenkman, MD Sheba Medical Center
Sheba Medical Center
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP