Improvement of Anxiety Management During a Venous Puncture About Children With a Participatory Entertainment Method
- Conditions
- Anxiety Disorders
- Interventions
- Procedure: "fabrique à histoire"Procedure: Usual care
- Registration Number
- NCT04200196
- Lead Sponsor
- University Hospital, Brest
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 116
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description "Fabrique à histoire" "fabrique à histoire" 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 Usual care 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.
- Primary Outcome Measures
Name Time Method modified Yale Preoperative Anxiety Scale (mYPAS) 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 Outcome Measures
Name Time Method 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)
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
Venous puncture success through study completion, an average of 2 hours Success or not (Yes/No) of the venous puncture
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)
Trial Locations
- Locations (1)
CHRU de Brest
🇫🇷Brest, Finistère, France