The Effects of Medical Clowns in Children Undergoing Blood Tests
Primary Purpose
Pain, Anxiety
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
clown
Sponsored by

About this trial
This is an interventional treatment trial for Pain focused on measuring Medical clown, Pediatric emergency medicine, Emergency procedures
Eligibility Criteria
Inclusion Criteria:
- Children needing venous blood sampling or the insertion of an intravenous canula
Exclusion Criteria:
- Children whose blood work or intravenous line must be accomplished rapidly for therapeutic reasons
- Absence of a parent during the procedure
- Abnormal development according to parents
Sites / Locations
- Tel-Aviv Sourasky Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Clown
No clown
Arm Description
A clown is present during venipuncture
Outcomes
Primary Outcome Measures
Pain score
recorded by the child
Secondary Outcome Measures
Parental anxiety level
recorded by the parent
Procedure's success rate
recorded by the nurse
Overall report of procedure's comfort
recorded by the nurse
Full Information
NCT ID
NCT01396876
First Posted
July 17, 2011
Last Updated
June 18, 2014
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01396876
Brief Title
The Effects of Medical Clowns in Children Undergoing Blood Tests
Official Title
Evaluation of the Effect of Hospital Clown's Performance in the Procedure Room of a Pediatric Emergency Department: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators hypothesized that the participation of therapeutic clowns in the pediatric emergency department procedure room would reduce anxiety, improve the level of cooperation children can provide and avoid some of the adverse effects.
Detailed Description
Research has demonstrated that cognitive psychological techniques, including distraction, can increase pain tolerance. Humor can be an important intervention, able to reduce stress to both the child and the parent. In the last decade there has been a rapid growth in the presence of therapeutic clowns in hospital, particularly in pediatric settings. If therapeutic clowns are shown to positively affect any of the parameters being measured in this study, they should be included as aprt of the standard of care in the pediatric emergency setting.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Anxiety
Keywords
Medical clown, Pediatric emergency medicine, Emergency procedures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clown
Arm Type
Active Comparator
Arm Description
A clown is present during venipuncture
Arm Title
No clown
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
clown
Intervention Description
a distraction technique is performed by a clown during venipuncture
Primary Outcome Measure Information:
Title
Pain score
Description
recorded by the child
Time Frame
at the end of the procedure
Secondary Outcome Measure Information:
Title
Parental anxiety level
Description
recorded by the parent
Time Frame
at the end of the procedure
Title
Procedure's success rate
Description
recorded by the nurse
Time Frame
at the end of the procedure
Title
Overall report of procedure's comfort
Description
recorded by the nurse
Time Frame
at the end of the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children needing venous blood sampling or the insertion of an intravenous canula
Exclusion Criteria:
Children whose blood work or intravenous line must be accomplished rapidly for therapeutic reasons
Absence of a parent during the procedure
Abnormal development according to parents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayelet Rimon, MD
Organizational Affiliation
Tel-Aviv Sourasky Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel-Aviv
Country
Israel
12. IPD Sharing Statement
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The Effects of Medical Clowns in Children Undergoing Blood Tests
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