The Effects of Medical Clowns in Children Undergoing Blood Tests

Pain Clinical Trial

Official title:

Evaluation of the Effect of Hospital Clown's Performance in the Procedure Room of a Pediatric Emergency Department: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01396876
• Other study ID #: TASMC-11-SR-525-CTIL
• Status: Completed
• Phase: N/A
• First received: July 17, 2011
• Last updated: June 18, 2014
• Start date: July 2011
• Est. completion date: December 2012

Study information

• Verified date: June 2014
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 10 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Pain

Intervention

Behavioral:
• clown
a distraction technique is performed by a clown during venipuncture

Locations

Country	Name	City	State
Israel	Tel-Aviv Sourasky Medical Center	Tel-Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score	recorded by the child	at the end of the procedure	No
Secondary	Parental anxiety level	recorded by the parent	at the end of the procedure	No
Secondary	Procedure's success rate	recorded by the nurse	at the end of the procedure	No
Secondary	Overall report of procedure's comfort	recorded by the nurse	at the end of the procedure	No