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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00535457
• Other study ID #: SHEBA-07-4786-ZS-CTIL
• Status: Withdrawn
• Phase: Phase 1
• First received: September 23, 2007
• Last updated: June 7, 2012

Study information

• Verified date: June 2012
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 12 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Other:
• Preoperative Magic Tricks
Watching "magic"; Study patients will watch the anesthesiologist performing tricks ("magic") before anesthesia induction.

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Tel Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	postoperative maladaptive behavior rate
Secondary	preoperative anxiety scores and rate of postoperative maladaptive behavior