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

March 24, 2019 updated by: omer raviv, Meir Medical Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Israel
      • Kfar Saba, Israel
        • Recruiting
        • Pediatrics Emergency Department
        • Contact:
          • Omer Raviv, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 day to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children population

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Medical clown
Medical clown will be present in the pediatric emergency department while assessing blood pressure during triage of patients.
Behavioral: Medical clown
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Accurate blood pressure assessment
Time Frame: 10 min
Blood pressure
10 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Meir Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Omer Raviv, MD, Meir Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 6, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MMC 034116 CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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