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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anxiety Disorders

Intervention / Treatment
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* Procedure: fabrique à histoire
* Procedure: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is an interventional prospective controlled study with 2 arms: the fabrique à histoire arm : production and listening a story by the children the controlled arm: usual care (to sing, blow up a baloon, etc)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fabrique à histoire<br>Children 3 to 6 years in pediatric emergency needing to venous puncture and randomized in the fabrique à histoire (Lunii(R)) arm in addition to the routine anaesthetic cream patch. | Procedure: fabrique à histoire<br>* 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.<br>|
| Active Comparator: Usual care<br>Children 3 to 6 years in pediatric emergency needing to venous puncture and randomized in the habitual care arm in addition to the routine anaesthetic cream patch. | Procedure: Usual care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | through study completion, an average of 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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) | 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) | through study completion, an average of 2 hours | 
| Number of venous puncture before success | Number of venous puncture tentative(s) before success | through study completion, an average of 2 hours | 
| Venous puncture success | Success or not (Yes/No) of the venous puncture | through study completion, an average of 2 hours | 
| Time before venous puncture success | Measure of time spent performing the act before its success | through study completion, an average of 2 hours | 
| Caregivers feedback | Assessment of caregivers feedback from the gesture with an AVS 0 (worst feeling) to 10 (best feeling) | through study completion, an average of 2 hours | 
| Parents feedback | Assessment of parents feedback from the gesture with an AVS 0 (worst feeling) to 10 (best feeling) | through study completion, an average of 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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children, anxiety