NCT01396876

Brief Summary

The investigators hypothesized that the participation of therapeutic clowns in the pediatric emergency department procedure room would reduce anxiety, improve the level of cooperation children can provide and avoid some of the adverse effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Jul 2011

Typical duration for not_applicable pain

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

June 19, 2014

Status Verified

June 1, 2014

Enrollment Period

1.4 years

First QC Date

July 17, 2011

Last Update Submit

June 18, 2014

Conditions

PainAnxiety

Keywords

Medical clownPediatric emergency medicineEmergency procedures

Outcome Measures

Primary Outcomes (1)

  • Pain score

    recorded by the child

    at the end of the procedure

Secondary Outcomes (3)

  • Parental anxiety level

    at the end of the procedure

  • Procedure's success rate

    at the end of the procedure

  • Overall report of procedure's comfort

    at the end of the procedure

Study Arms (2)

Clown

ACTIVE COMPARATOR

A clown is present during venipuncture

Behavioral: clown

No clown

NO INTERVENTION

Interventions

clownBEHAVIORAL

a distraction technique is performed by a clown during venipuncture

Clown

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children needing venous blood sampling or the insertion of an intravenous canula

You may not qualify if:

  • Children whose blood work or intravenous line must be accomplished rapidly for therapeutic reasons
  • Absence of a parent during the procedure
  • Abnormal development according to parents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

PainAnxiety Disorders

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Study Officials

  • Ayelet Rimon, MD

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

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

July 17, 2011

First Posted

July 19, 2011

Study Start

July 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

June 19, 2014

Record last verified: 2014-06

Locations

IL(1)