NCT03143088

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

August 6, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 27, 2019

Status Verified

March 1, 2019

Enrollment Period

1.8 years

First QC Date

May 4, 2017

Last Update Submit

March 24, 2019

Conditions

Children Referred to the Pediatric Emergency Department

Keywords

Blood pressureMedical clownPediatric

Outcome Measures

Primary Outcomes (1)

  • Accurate blood pressure assessment

    Blood pressure

    10 min

Study Arms (2)

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 assessment

Blood pressure will be measured by the medical center protocols.

Interventions

Medical clownBEHAVIORAL

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

Medical clown

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Children population

You may qualify if:

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

You may not qualify if:

  • Serious medical condition requiring emergent medical care or resuscitation
  • Parental refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatrics Emergency Department

Kfar Saba, Israel

RECRUITING

Study Officials

  • Omer Raviv, MD

    Meir Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Omer Raviv, MD

CONTACT

972528822052omerol@walla.co.il

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 4, 2017

First Posted

May 8, 2017

Study Start

August 6, 2017

Primary Completion

June 1, 2019

Study Completion

December 1, 2019

Last Updated

March 27, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)