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The Effects of Medical Clowns in Children Undergoing Blood Tests

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ClinicalTrials.gov Identifier: NCT01396876
Recruitment Status : Completed
First Posted : July 19, 2011
Last Update Posted : June 19, 2014
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

July 17, 2011
July 19, 2011
June 19, 2014
July 2011
December 2012   (Final data collection date for primary outcome measure)
Pain score [ Time Frame: at the end of the procedure ]
recorded by the child
Same as current
Complete list of historical versions of study NCT01396876 on ClinicalTrials.gov Archive Site
  • Parental anxiety level [ Time Frame: at the end of the procedure ]
    recorded by the parent
  • Procedure's success rate [ Time Frame: at the end of the procedure ]
    recorded by the nurse
  • Overall report of procedure's comfort [ Time Frame: at the end of the procedure ]
    recorded by the nurse
Same as current
Not Provided
Not Provided
 
The Effects of Medical Clowns in Children Undergoing Blood Tests
Evaluation of the Effect of Hospital Clown's Performance in the Procedure Room of a Pediatric Emergency Department: A Randomized Controlled Trial
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Pain
  • Anxiety
Behavioral: clown
a distraction technique is performed by a clown during venipuncture
  • Active Comparator: Clown
    A clown is present during venipuncture
    Intervention: Behavioral: clown
  • No Intervention: No clown
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2012
December 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
3 Years to 10 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT01396876
TASMC-11-SR-525-CTIL
No
Not Provided
Not Provided
Tel-Aviv Sourasky Medical Center
Tel-Aviv Sourasky Medical Center
Not Provided
Principal Investigator: Ayelet Rimon, MD Tel-Aviv Sourasky Medical Center
Tel-Aviv Sourasky Medical Center
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP