The Effects of Pre-operative Magic Tricks Performance on Pre-operative Anxiety in Children
Primary Purpose
Anxiety
Status
Withdrawn
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Preoperative Magic Tricks
Sponsored by
About this trial
This is an interventional prevention trial for Anxiety focused on measuring anxiety, maladaptive behavior, anesthesia, Anxiety before anesthesia and maladaptive behavior after anesthesia.
Eligibility Criteria
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.
Sites / Locations
- Sheba Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Children will watch tricks ("magic") before anesthesia induction
Outcomes
Primary Outcome Measures
anxiety scores
postoperative maladaptive behavior rate
Secondary Outcome Measures
preoperative anxiety scores and rate of postoperative maladaptive behavior
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00535457
Brief Title
The Effects of Pre-operative Magic Tricks Performance on Pre-operative Anxiety in Children
Official Title
The Effects of Pre-operative Magic Tricks Performance on Pre-operative Anxiety in Children
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
anxiety, maladaptive behavior, anesthesia, Anxiety before anesthesia and maladaptive behavior after anesthesia.
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Children will watch tricks ("magic") before anesthesia induction
Intervention Type
Other
Intervention Name(s)
Preoperative Magic Tricks
Intervention Description
Watching "magic"; Study patients will watch the anesthesiologist performing tricks ("magic") before anesthesia induction.
Primary Outcome Measure Information:
Title
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.
Title
postoperative maladaptive behavior rate
Secondary Outcome Measure Information:
Title
preoperative anxiety scores and rate of postoperative maladaptive behavior
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ze'ev Shenkman, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
The Effects of Pre-operative Magic Tricks Performance on Pre-operative Anxiety in Children
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