The Effects of Medical Clowns in Children Undergoing Blood Tests

• Sponsor: Tel-Aviv Sourasky Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01396876
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 17.1
• Patients Per Site Per Month: 3.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain; Anxiety	Behavioral: clown	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: Jul 1, 2011
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Pain score [at the end of the procedure]

   recorded by the child

Secondary Outcome Measures

1. Parental anxiety level [at the end of the procedure]

   recorded by the parent

2. Procedure's success rate [at the end of the procedure]

   recorded by the nurse

3. Overall report of procedure's comfort [at the end of the procedure]

   recorded by the nurse

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 10 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tel-Aviv Sourasky Medical Center
• ClinicalTrials.gov Identifier: NCT01396876
• Other Study ID Numbers: TASMC-11-SR-525-CTIL
• First Posted: Jul 19, 2011
• Last Update Posted: Jun 19, 2014
• Last Verified: Jun 1, 2014

• Keywords provided by Tel-Aviv Sourasky Medical Center: Medical clown; Pediatric emergency medicine; Emergency procedures
• Additional relevant MeSH terms: Emergencies

Study Results

No Results Posted as of Jun 19, 2014