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The Effects of Medical Clowns in Children Undergoing Blood Tests

This study is currently recruiting participants.
Verified July 2011 by Tel-Aviv Sourasky Medical Center
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01396876
First received: July 17, 2011
Last updated: July 18, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention
Pain and Anxiety Reduction
 Behavioral: clown

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Effect of Hospital Clown's Performance in the Procedure Room of a Pediatric Emergency Department: A Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Pain score [ Time Frame: at the end of the procedure ] [ Designated as safety issue: No ]
    recorded by the child


Secondary Outcome Measures:
  • Parental anxiety level [ Time Frame: at the end of the procedure ] [ Designated as safety issue: No ]
    recorded by the parent

  • Procedure's success rate [ Time Frame: at the end of the procedure ] [ Designated as safety issue: No ]
    recorded by the nurse

  • Overall report of procedure's comfort [ Time Frame: at the end of the procedure ] [ Designated as safety issue: No ]
    recorded by the nurse


Estimated Enrollment: 100
Study Start Date: July 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Clown
A clown is present during venipuncture
 Behavioral: clown
a distraction technique is performed by a clown during venipuncture
No Intervention: No clown

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.

  Eligibility

Ages Eligible for Study:   3 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01396876

Contacts
Contact: Ido Wolyniez, MD +972-52-6704300 ido.wolyniez@gmail.com

Locations
Israel
Tel-Aviv Sourasky Medical Center Recruiting
Tel-Aviv, Israel
Contact: Ido Wolyniez, MD         ido.wolyniez@gmail.com    
Sub-Investigator: Ido Wolyniez, MD            
Sub-Investigator: Ayelet Rimon, MD            
Sub-Investigator: Miguel Glatstein, MD            
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

Responsible Party: Tel-Aviv Sourasky Medical Center (Shimon Reif), Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01396876     History of Changes
Other Study ID Numbers: TASMC-11-SR-525-CTIL
Study First Received: July 17, 2011
Last Updated: July 18, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
Medical clown
children
pain
anxiety
emergency procedures

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013