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

NCT ID: NCT03143088

Last Updated: 2019-03-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-08-06
• Study Completion Date: 2019-12-01

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.

Conditions

Children Referred to the Pediatric Emergency Department

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Medical clown

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

Medical clown

Intervention Type: BEHAVIORAL

Blood pressure will be taken to children admitted to the pediatric emergency department with and without the presence of a medical clown.

Blood pressure assessment

Blood pressure will be measured by the medical center protocols.

No interventions assigned to this group

Interventions

Medical clown

Blood pressure will be taken to children admitted to the pediatric emergency department with and without the presence of a medical clown.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

1. Serious medical condition requiring emergent medical care or resuscitation

2. Parental refusal to participate in the study

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

omer raviv

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Omer Raviv, MD

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center

Locations

Pediatrics Emergency Department

Kfar Saba, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Omer Raviv, MD

Role: CONTACT

omerol@walla.co.il

972528822052

Facility Contacts

Omer Raviv, MD

Role: primary

Other Identifiers

MMC 034116 CTIL

Identifier Type: -

Identifier Source: org_study_id