An interventional study of "fabrique à histoire" and Usual care in Anxiety Disorders, sponsored by University Hospital, Brest. Completed at 1 site in France. Open to participants aged 3 Years to 6 Years. Per ClinicalTrials.gov, last updated 2025-02-24.
Sponsored by University Hospital, Brest · Not applicable, Interventional, and Other
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 116 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →University Hospital, Brest is the lead sponsor of 594 studies on the registry; 135 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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"
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
"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.
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.
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
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)
Time frame: through study completion, an average of 2 hours
Number of venous puncture before success
Number of venous puncture tentative(s) before success
Time frame: through study completion, an average of 2 hours
Venous puncture success
Success or not (Yes/No) of the venous puncture
Time frame: through study completion, an average of 2 hours
Time before venous puncture success
Measure of time spent performing the act before its success
Time frame: 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)
Time frame: 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)
Time frame: through study completion, an average of 2 hours
Plan to share: Yes — All collected data that underlie results in a publication
Supporting information: Study protocol
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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University Hospital, Brest