Improvement of Anxiety Management During a Venous Puncture About Children with a Participatory Entertainment Method
NCT ID: NCT04200196
Last Updated: 2025-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
116 participants
INTERVENTIONAL
2020-06-25
2024-08-05
Brief Summary
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Detailed Description
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the study will compare the "fabrique à histoire"(Lunii(R)) with the usual care.
Conditions
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Study Design
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NA
PARALLEL
* 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)
OTHER
NONE
Study Groups
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"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.
"fabrique 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.
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.
Usual 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.
Interventions
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"fabrique 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.
Usual 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Necessity to analgesic 3 emergency
* Necessity to MEOPA
* Minor parents
* Assessment of anxiety is not possible because of comorbidity
* Anterior participation to these study
3 Years
6 Years
ALL
No
Sponsors
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University Hospital, Brest
OTHER
Responsible Party
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Locations
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CHRU de Brest
Brest, Finistère, France
Countries
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Other Identifiers
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29BRC19.0189
Identifier Type: -
Identifier Source: org_study_id
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