The Effects of Pre-operative Magic Tricks Performance on Pre-operative Anxiety in Children
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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 |
- 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
- 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 |
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 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 May 23, 2013