Improvement of Anxiety Management During a Venous Puncture About Children with a Participatory Entertainment Method

N/ACompletedNCT04200196

University Hospital, Brest116 enrolled

Overview

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 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

116

Conditions

Anxiety Disorders

Interventions

"fabrique à histoire"PROCEDURE

"Fabrique à histoire" is a participatory entertainment method. Children of this arm going to create and listening a story before and during the venous puncture.

Usual carePROCEDURE

It is a passive entertainment method. Children of this arm going to do habitual activities before and during the venous puncture, like to sing, blow up a balloon, to play with recreational thing, etc.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 6 Years

Medical Language ↔ Plain English

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

Locations (1)

CHRU de Brest

Brest, Finistère, France

Outcomes

Primary Outcomes

modified Yale Preoperative Anxiety Scale (mYPAS)

Evolution of mYPAS (validated anxiety scale with a scale 23,3 (no anxiety) to 100 (max of anxiety) between T0 (before venipuncture) and T1 (venipuncture). mYPAS is quoted by an extern observator

Time frame: During venipuncture, an average of 1,5 hours

modified Yale Preoperative Anxiety Scale (mYPAS)

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.

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

Secondary Outcomes

Children face scale

Evolution of Self-assessment of pain with the face scale caused by the venous puncture for children 4 to 6 years between T0 and T2 (after venipuncture)

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

FLACC Scale

Evolution assessment of pain caused by the venous puncture for children assess by caregivers and measured with FLACC Scale (Face Legs Activity Cry Consolability / 0=no pain and 10=max pain) between T0 and T2 (after venipuncture)

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

Parent anxiety assessment

Assessment of anxiety caused by the venous puncture for children assess by parents at T2 with an Analogue and Visual Scale (AVS) 10 levels (0=No anxiety 10=max anxiety)

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

Parent pain assessment

Assessment of pain caused by the venous puncture for children assess by parents at T2 with an AVS 10 level (0=No pain 10=max pain)

Data from ClinicalTrials.gov

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