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Clinical Trials/NCT00535457
NCT00535457
Withdrawn
Phase 1

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

Sheba Medical Center1 site in 1 countrySeptember 26, 2007
ConditionsAnxiety

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Anxiety
Sponsor
Sheba Medical Center
Locations
1
Primary Endpoint
anxiety scores
Status
Withdrawn
Last Updated
13 years ago

Overview

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.

  1. Similar rates of postoperative maladaptive behavior will be found in children that that will see tricks and in those that will receive midazolam premedication.
Registry
clinicaltrials.gov
Start Date
September 26, 2007
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility 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.

Outcomes

Primary Outcomes

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.

postoperative maladaptive behavior rate

Secondary Outcomes

  • preoperative anxiety scores and rate of postoperative maladaptive behavior

Study Sites (1)

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