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

July 12, 2023 updated by: University Hospital, Brest

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

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".

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 6 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: "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.
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.
Active Comparator: 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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
modified Yale Preoperative Anxiety Scale (mYPAS)
Time Frame: During venipuncture, an average of 1,5 hours
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)
Time Frame: through study completion, an average of 2 hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Children face scale
Time Frame: through study completion, an average of 2 hours
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
FLACC Scale
Time Frame: through study completion, an average of 2 hours
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
Parent anxiety assessment
Time Frame: through study completion, an average of 2 hours
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
Parent pain assessment
Time Frame: through study completion, an average of 2 hours
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
Number of venous puncture before success
Time Frame: through study completion, an average of 2 hours
Number of venous puncture tentative(s) before success
through study completion, an average of 2 hours
Venous puncture success
Time Frame: through study completion, an average of 2 hours
Success or not (Yes/No) of the venous puncture
through study completion, an average of 2 hours
Time before venous puncture success
Time Frame: through study completion, an average of 2 hours
Measure of time spent performing the act before its success
through study completion, an average of 2 hours
Caregivers feedback
Time Frame: through study completion, an average of 2 hours
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
Parents feedback
Time Frame: through study completion, an average of 2 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2020

Primary Completion (Estimated)

December 25, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

December 11, 2019

First Submitted That Met QC Criteria

December 13, 2019

First Posted (Actual)

December 16, 2019

Study Record Updates

Last Update Posted (Actual)

July 13, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29BRC19.0189

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected data that underlie results in a publication

IPD Sharing Time Frame

Data will be available after the publication of result and ending fifteen years following the last visit of the last patient

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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