The Effect of Medical Clowns on Blood Pressure Measurement in Children Presenting to the Emergency Department

• Conditions: Children Referred to the Pediatric Emergency Department
• Interventions: Behavioral: Medical clown

• Registration Number: NCT03143088
• Lead Sponsor: Meir Medical Center

Brief Summary

Obtaining vital signs and blood pressure (BP) in particularly, as part of a pediatric Emergency Department (ED) patient triage is sometimes difficult and leads to many false negative results.

The stress, noisy environment and lack of cooperation are only a few of the things that interfere with proper vital signs measurements.

In the past decade, there has been a rapid growth in the presence of therapeutic clowns in hospitals, particularly in pediatric settings.

The investigators speculate that the incorporation of a medical clown during the procedure of blood pressure measurement in the triage will shorten the procedure and decrease the number of attempts, making it much more efficient.

Detailed Description

Blood pressure is measured in the triage amongst most children presented to the Pediatric ED.

There are many barriers to obtaining an accurate BP measurement in children, including inappropriate technique, lack of equipment, but also - pain, and the child's uncooperativeness or anxiety. The latter may even be accentuated in an ED setting.

These factors may lead to falsely elevated BP readings, which may provoke significant anxiety in children and families and possibly lead to a cascade of unnecessary investigation and consultations.

Additionally, an abnormal measured BP value routinely mandate an additional measurement attempt which itself may cause anxiety and restlessness among children, especially toddlers and infants, and prolongs the entire triage process.

The Second Task Force Report on Blood Pressure Control in Children emphasizes taking blood pressure measurements in a quiet environment, using a proper size cuff and using appropriate technique. Ideally, BP should be measured several times in a a relaxed child and in a quiet setting, however this scenario is nearly impossible in the ED, as demonstrated in a previous retrospective study that indicated that although BP was elevated in 52% of children who underwent triage blood pressure measurement in the ED, the measurement was repeated in only 38%.

In the past decade, there has been a rapid growth in the presence of therapeutic clowns in hospitals, particularly in pediatric settings. A recent study conducted in a pediatric ED in Israel has demonstrated the benefit of medical clowns in diminishing pain and anxiety during painful procedures being performed on children in the ED.

Previous studies conducted in our institute have demonstrated a beneficial effect on vital signs (blood pressure and heart rate) as a sign of decreased anxiety following the incorporation of a medical clown in a multisystem team caring for pediatric patient.

Blood pressure measurement among pediatric patients, although not a painful procedure, may cause a stressful reaction, prolonging the entire process and requiring additional attempts - making it a time consuming task in a busy ED.

A medical clown may have a beneficial effect on the pediatric patient by decreasing the stress reaction and may therefore shorten the entire process making it much more efficient.

The investigators are unaware of any studies conducted related to the effect of the use of medical clowns during ED blood pressure measurements in the triage.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-05-04
• Study First Submitted QC: 2017-05-04
• Study First Posted: 2017-05-08
• Study Start: 2017-08-06
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-24
• Last Update Posted: 2019-03-27
• Primary Completion: 2019-06-01
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Children aged 1 day to 18 years presenting to the ED.

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Exclusion Criteria

1. Serious medical condition requiring emergent medical care or resuscitation
2. Parental refusal to participate in the study

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Medical clown	Medical clown	Medical clown will be present in the pediatric emergency department while assessing blood pressure during triage of patients.

Primary Outcome Measures

Name	Time	Method
Accurate blood pressure assessment	10 min	Blood pressure

Trial Locations

Locations (1)

Pediatrics Emergency Department; 🇮🇱 Kfar Saba, Israel