NCT04200196

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".

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 16, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

June 25, 2020

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2024

Completed
Last Updated

February 24, 2025

Status Verified

February 1, 2025

Enrollment Period

4.1 years

First QC Date

December 11, 2019

Last Update Submit

February 21, 2025

Conditions

Anxiety Disorders

Keywords

anxietychildren

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (9)

  • Children face scale

    through study completion, an average of 2 hours

  • FLACC Scale

    through study completion, an average of 2 hours

  • Parent anxiety assessment

    through study completion, an average of 2 hours

  • Parent pain assessment

    through study completion, an average of 2 hours

  • Number of venous puncture before success

    through study completion, an average of 2 hours

  • +4 more secondary outcomes

Study Arms (2)

"Fabrique à histoire"

EXPERIMENTAL

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"

Usual care

ACTIVE COMPARATOR

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

Interventions

"fabrique à histoire"PROCEDURE

"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.

"Fabrique à histoire"
Usual carePROCEDURE

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.

Usual care

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, Finistère, 29200, France

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: This study is an interventional prospective controlled study with 2 arms: * 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)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2019

First Posted

December 16, 2019

Study Start

June 25, 2020

Primary Completion

August 5, 2024

Study Completion

August 5, 2024

Last Updated

February 24, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
Access Criteria
Data access requests will be reviewed by the internal committee of Brest University Hospital. Requestors will be required to sign and complete a data access agreement.

Locations

FR(1)