Improvement of Anxiety Management During a Venous Puncture About Children with a Participatory Entertainment Method (PEDIPAIN)

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Anxiety Disorders

Treatments: Procedure: "fabrique à histoire"; Procedure: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT04200196

29BRC19.0189

Details and patient eligibility

About

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".

Full 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.

Enrollment: 116 patients

Sex: All

Ages: 3 to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

"Fabrique à histoire"

Experimental group

Description:

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.

Treatment:

Procedure: "fabrique à histoire"

Usual care

Active Comparator group

Description:

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.

Treatment:

Procedure: Usual care