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Clowns as Treatment for Preoperative Anxiety in Children: A Randomized Controlled Trial

Primary Purpose

Pre Operative Anxiety

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
clowns present
midazolam
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pre Operative Anxiety focused on measuring children anesthesia anxiety clowns

Eligibility Criteria

2 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA I and II
  • Children aged 2-8 years

Exclusion Criteria:

  • Previous surgery
  • ASA > II
  • Parents' refusal

Sites / Locations

  • Sheba Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

no medication or clowns present during the preopertaive phase

midazolam a anxiolytic drug was given in the preoperative phase

clowns where present during the preoperative phase

Outcomes

Primary Outcome Measures

anxiety level

Secondary Outcome Measures

Full Information

First Posted
January 24, 2008
Last Updated
February 6, 2008
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00609960
Brief Title
Clowns as Treatment for Preoperative Anxiety in Children: A Randomized Controlled Trial
Official Title
Clowns as Treatment for Preoperative Anxietyin Children- a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sheba Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study wants to test the hypothesis that trained clowns can reduce anxiety in children undergoing general anesthesia. We will compare the effect of the clowns to the commonly used anti-anxiety medication we commonly use
Detailed Description
The perioperative environment, often anxiety-provoking for adults, may be quite frightening for children. The detrimental effects of preoperative anxiety are not confined to the preoperative period. Anxiety during induction of anesthesia is correlated with increased distress early in the postoperative period, (Holms Knud, Kain) and maladaptive behavior will follow for the first 2 weeks following surgery in up to 54% of children. Many preoperative systems allow parental, pharmacologic, and anticipatory interventions to facilitate a relaxed perioperative environment for children. Unfortunately, scheduling conflicts, side effects, and limited resources conspire to limit their usefulness. For example, only 10% of respondents in a recent survey used parental presence during induction of anesthesia (PPIA) for a majority of their patients. This may be due to the belief by some that parental anxiety may in fact increase children's anxiety. (Bevans) According to the same survey, only 50% of children undergoing surgery receive sedating premedication. (Kain). Distraction techniques, such as the use of toys or video games, may also decrease perioperative anxiety, however their effectiveness during induction of anesthesia is not well characterized. The efficacy of toys and video games is somewhat dependent upon the child reaching certain developmental milestones. Anesthesiologists continue to search for an easy and comprehensive method for anxiety reduction in the pediatric surgical population. We propose that specially trained professional clowns may allay preoperative anxiety and result in a smooth anesthetic induction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre Operative Anxiety
Keywords
children anesthesia anxiety clowns

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
no medication or clowns present during the preopertaive phase
Arm Title
2
Arm Type
Active Comparator
Arm Description
midazolam a anxiolytic drug was given in the preoperative phase
Arm Title
3
Arm Type
Active Comparator
Arm Description
clowns where present during the preoperative phase
Intervention Type
Behavioral
Intervention Name(s)
clowns present
Intervention Description
clowns present during the proccess of induction of anesthesia
Intervention Type
Drug
Intervention Name(s)
midazolam
Intervention Description
midazolam
Primary Outcome Measure Information:
Title
anxiety level
Time Frame
waiting area and enterance to OR -1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA I and II Children aged 2-8 years Exclusion Criteria: Previous surgery ASA > II Parents' refusal
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilan Keidan, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Medical Center
City
Tel Hashomer
State/Province
Ramat Gan
ZIP/Postal Code
52621
Country
Israel

12. IPD Sharing Statement

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Clowns as Treatment for Preoperative Anxiety in Children: A Randomized Controlled Trial

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