The Effects of Medical Clowns in Children Undergoing Blood Tests

Not Applicable

Completed

• Conditions: Pain; Anxiety
• Interventions: Behavioral: clown

• Registration Number: NCT01396876
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

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.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-17
• Study First Submitted QC: 2011-07-18
• Study First Posted: 2011-07-19
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-18
• Last Update Posted: 2014-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clown	clown	A clown is present during venipuncture

Primary Outcome Measures

Name	Time	Method
Pain score	at the end of the procedure	recorded by the child

Secondary Outcome Measures

Name	Time	Method
Overall report of procedure's comfort	at the end of the procedure	recorded by the nurse
Parental anxiety level	at the end of the procedure	recorded by the parent
Procedure's success rate	at the end of the procedure	recorded by the nurse

Trial Locations

Locations (1)

Tel-Aviv Sourasky Medical Center; 🇮🇱 Tel-Aviv, Israel