NCT02168998

Brief Summary

The purpose of this study is to determine whether the presence of a medical clown in a pediatric emergency department procedure room would reduce children's anxiety. The investigators hypothesize that this positive influence will be expressed as lower levels of the stress hormone (Cortisol) in the blood.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

July 26, 2018

Status Verified

April 1, 2016

Enrollment Period

1.7 years

First QC Date

June 18, 2014

Last Update Submit

July 25, 2018

Conditions

Stress, Physiological

Keywords

Medical clownPediatric emergency medicine

Outcome Measures

Primary Outcomes (1)

  • Blood Cortisol level

    During intravenous cannulation or blood sampling

Secondary Outcomes (1)

  • Vital signs (heart rate, respiratory rate, blood pressure)

    During intravenous cannulation or blood sampling

Study Arms (2)

No clown

NO INTERVENTION

Routine venipuncture without distraction

Clown

ACTIVE COMPARATOR

A medical clown is present in the procedure room during venipuncture

Behavioral: Clown

Interventions

ClownBEHAVIORAL

Comparison of routine venipuncture with a distraction technique by a medical clown

Clown

Eligibility Criteria

Age1 Year - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients needing venous blood sampling or insertion of an intravenous canula
  • Normal development according to parents

You may not qualify if:

  • Critically ill children (e.g. shock, respiratory distress or failure)
  • Children whose blood work or intravenous canula must be obtained rapidly for therapeutic reasons (e.g. antibiotic administration in a patient with severe bacterial infections)
  • Known adrenal or pituitary disease
  • Children who have received glucocorticoids during the preceeding six weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

MeSH Terms

Interventions

Laughter Therapy

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Study Officials

  • Ayelet Rimon, MD

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

  • Miguel Glatstein, MD

    Tel-Aviv Sourasky Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2014

First Posted

June 20, 2014

Study Start

August 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

July 26, 2018

Record last verified: 2016-04

Locations

IL(1)