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This study has been withdrawn prior to enrollment.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
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: The Effects of Pre-operative Magic Tricks Performance on Pre-operative Anxiety in Children

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • 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

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

Enrollment: 0
Arms Assigned Interventions
Experimental: 1
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00535457

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

No publications provided

Responsible Party: Ze'ev Shenkman, MD, Sheba Medical Center, Department of Anesthesia C
ClinicalTrials.gov Identifier: NCT00535457     History of Changes
Other Study ID Numbers: SHEBA-07-4786-ZS-CTIL
Study First Received: September 23, 2007
Last Updated: June 7, 2012
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.

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014