The Effects of Medical Clowns in Children Undergoing Blood Tests

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01396876
First received: July 17, 2011
Last updated: June 18, 2014
Last verified: June 2014
  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
Anxiety
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:


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


Enrollment: 60
Study Start Date: July 2011
Study Completion Date: December 2012
Primary Completion Date: December 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01396876

Locations
Israel
Tel-Aviv Sourasky Medical Center
Tel-Aviv, Israel
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Ayelet Rimon, MD Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

Responsible Party: 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: June 18, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
Medical clown
Pediatric emergency medicine
Emergency procedures

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 26, 2014