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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
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Medical clown, Pediatric emergency medicine, Emergency procedures

Eligibility Criteria

3 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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

First Posted
July 17, 2011
Last Updated
June 18, 2014
Sponsor
Tel-Aviv Sourasky Medical Center
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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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