Improvement of Anxiety Management During a Venous Puncture About Children 3 to 6 Years, With a Participatory Entertainment Method

University Hospital, Brest1 site in 1 country116 target enrollmentJune 25, 2020

ConditionsAnxiety Disorders

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Anxiety Disorders
Sponsor: University Hospital, Brest
Enrollment: 116
Locations: 1
Primary Endpoint: modified Yale Preoperative Anxiety Scale (mYPAS)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to demonstrate an anxiety decrease about children 3 to 6 years during a venous puncture with the "fabrique à histoire".

Detailed Description

The purpose of this study is to demonstrate an anxiety decrease about children 3 to 6 years during a venous puncture with the "fabrique à histoire". the study will compare the "fabrique à histoire"(Lunii(R)) with the usual care.

Registry

clinicaltrials.gov

Start Date

June 25, 2020

End Date

August 5, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital, Brest

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Children 3 to 6 years in pediatric emergency needing to venous puncture
•Oral consent by children
•Informed and signed consent by tenured of parent authority
•To have Anaesthetic patch 45 minutes or more before the venous puncture

Exclusion Criteria

•To have Anaesthetic patch less than 45 minutes before the venous puncture because of necessity to blood test or an other emergency
•Necessity to analgesic 3 emergency
•Necessity to MEOPA
•Minor parents
•Assessment of anxiety is not possible because of comorbidity
•Anterior participation to these study

Outcomes

Primary Outcomes

modified Yale Preoperative Anxiety Scale (mYPAS)

Time Frame: through study completion, an average of 2 hours

Evolution of mYPAS (validated anxiety scale with a scale 23,3 (no anxiety) to 100 (max of anxiety) between T0 and T2 (after venipuncture). mYPAS is quoted by an extern observator.

Secondary Outcomes

Children face scale(through study completion, an average of 2 hours)
FLACC Scale(through study completion, an average of 2 hours)
Parent anxiety assessment(through study completion, an average of 2 hours)
Parent pain assessment(through study completion, an average of 2 hours)
Number of venous puncture before success(through study completion, an average of 2 hours)
Venous puncture success(through study completion, an average of 2 hours)
Time before venous puncture success(through study completion, an average of 2 hours)
Caregivers feedback(through study completion, an average of 2 hours)
Parents feedback(through study completion, an average of 2 hours)