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

NCT ID: NCT00535457

Last Updated: 2012-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Children will watch tricks ("magic") before anesthesia induction

Group Type EXPERIMENTAL

Preoperative Magic Tricks

Intervention Type OTHER

Watching "magic"; Study patients will watch the anesthesiologist performing tricks ("magic") before anesthesia induction.

Interventions

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Preoperative Magic Tricks

Watching "magic"; Study patients will watch the anesthesiologist performing tricks ("magic") before anesthesia induction.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sheba Medical Center, Department of Anesthesia C

Principal Investigators

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Ze'ev Shenkman, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

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Sheba Medical Center

Tel Litwinsky, , Israel

Site Status

Countries

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Israel

Other Identifiers

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SHEBA-07-4786-ZS-CTIL

Identifier Type: -

Identifier Source: org_study_id

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