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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Fabrique à histoire" | Experimental | 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. |
|
| Usual care | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Brest | Brest | Finistère | 29200 | France |
All collected data that underlie results in a publication
Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
Data access requests will be reviewed by the internal committee of Brest University Hospital. Requestors will be required to sign and complete a data access agreement.
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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This study is an interventional prospective controlled study with 2 arms:
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| Usual care | Procedure | 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. |
|
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 |