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

Phase 1

Withdrawn

• Conditions: Anxiety
• Interventions: Other: Preoperative Magic Tricks

• Registration Number: NCT00535457
• Lead Sponsor: Sheba Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-09-23
• Study First Submitted QC: 2007-09-25
• Study First Posted: 2007-09-26
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-07
• Last Update Posted: 2012-06-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Preoperative Magic Tricks	Children will watch tricks ("magic") before anesthesia induction

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
preoperative anxiety scores and rate of postoperative maladaptive behavior

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Tel Hashomer, Israel