Anxiety Disorders
Conditions
Keywords
anxiety, children
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.
Interventions
PROCEDUREfabrique à histoire
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.
PROCEDUREUsual care
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.
Sponsors
University Hospital, Brest
Study design
Allocation
NA
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention 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)
Eligibility
Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| modified Yale Preoperative Anxiety Scale (mYPAS) | During venipuncture, an average of 1,5 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FLACC Scale | through study completion, an average of 2 hours | 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) |
| Parent anxiety assessment | through study completion, an average of 2 hours | 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) |
| Parent pain assessment | through study completion, an average of 2 hours | 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) |
| Number of venous puncture before success | through study completion, an average of 2 hours | Number of venous puncture tentative(s) before success |
| Children face scale | through study completion, an average of 2 hours | 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 before venous puncture success | through study completion, an average of 2 hours | Measure of time spent performing the act before its success |
| Caregivers feedback | through study completion, an average of 2 hours | Assessment of caregivers feedback from the gesture with an AVS 0 (worst feeling) to 10 (best feeling) |
| Parents feedback | through study completion, an average of 2 hours | Assessment of parents feedback from the gesture with an AVS 0 (worst feeling) to 10 (best feeling) |
| Venous puncture success | through study completion, an average of 2 hours | Success or not (Yes/No) of the venous puncture |
Countries
France
Outcome results
None listed