Improvement of Anxiety Management During a Venous Puncture About Children With a Participatory Entertainment Method

Anxiety Disorders Clinical Trial

— PEDIPAIN  

Official title:

Improvement of Anxiety Management During a Venous Puncture About Children 3 to 6 Years, With a Participatory Entertainment Method

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04200196
• Other study ID #: 29BRC19.0189
• Status: Recruiting
• Phase: N/A
• Start date: June 25, 2020
• Est. completion date: December 30, 2024

Study information

• Verified date: July 2023
• Source: University Hospital, Brest
• Contact: Morgane CABON
• Phone: 02 98 22 34 88
• Email: morgane.cabon[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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".

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 information / eligibility

• Status: Recruiting
• Enrollment: 136
• Est. completion date: December 30, 2024
• Est. primary completion date: December 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

Procedure:
• "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.

Locations

Country	Name	City	State
France	CHRU de Brest	Brest	Finistère

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	During venipuncture, an average of 1,5 hours
Primary	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.	through study completion, an average of 2 hours
Secondary	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)	through study completion, an average of 2 hours
Secondary	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)	through study completion, an average of 2 hours
Secondary	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)	through study completion, an average of 2 hours
Secondary	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)	through study completion, an average of 2 hours
Secondary	Number of venous puncture before success	Number of venous puncture tentative(s) before success	through study completion, an average of 2 hours
Secondary	Venous puncture success	Success or not (Yes/No) of the venous puncture	through study completion, an average of 2 hours
Secondary	Time before venous puncture success	Measure of time spent performing the act before its success	through study completion, an average of 2 hours
Secondary	Caregivers feedback	Assessment of caregivers feedback from the gesture with an AVS 0 (worst feeling) to 10 (best feeling)	through study completion, an average of 2 hours
Secondary	Parents feedback	Assessment of parents feedback from the gesture with an AVS 0 (worst feeling) to 10 (best feeling)	through study completion, an average of 2 hours