NCT00535457

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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 26, 2007

Completed
Last Updated

June 8, 2012

Status Verified

June 1, 2012

First QC Date

September 23, 2007

Last Update Submit

June 7, 2012

Conditions

Anxiety

Keywords

anxietymaladaptive behavioranesthesiaAnxiety before anesthesia and maladaptive behavior after anesthesia.

Outcome Measures

Primary Outcomes (2)

  • anxiety scores

    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 (1)

  • preoperative anxiety scores and rate of postoperative maladaptive behavior

Study Arms (1)

1

EXPERIMENTAL

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

Other: Preoperative Magic Tricks

Interventions

Preoperative Magic TricksOTHER

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

1

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Ze'ev Shenkman, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 23, 2007

First Posted

September 26, 2007

Last Updated

June 8, 2012

Record last verified: 2012-06

Locations

IL(1)