Improvement of Anxiety Management During a Venous Puncture About Children With a Participatory Entertainment Method (PEDIPAIN)
Primary Purpose
Anxiety Disorders
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
"fabrique à histoire"
Usual care
Sponsored by
About this trial
This is an interventional other trial for Anxiety Disorders focused on measuring anxiety, children
Eligibility Criteria
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
Sites / Locations
- CHRU de BrestRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
"Fabrique à histoire"
Usual care
Arm 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.
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.
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
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)
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)
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)
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)
Number of venous puncture before success
Number of venous puncture tentative(s) before success
Venous puncture success
Success or not (Yes/No) of the venous puncture
Time before venous puncture success
Measure of time spent performing the act before its success
Caregivers feedback
Assessment of caregivers feedback from the gesture with an AVS 0 (worst feeling) to 10 (best feeling)
Parents feedback
Assessment of parents feedback from the gesture with an AVS 0 (worst feeling) to 10 (best feeling)
Full Information
NCT ID
NCT04200196
First Posted
December 11, 2019
Last Updated
July 12, 2023
Sponsor
University Hospital, Brest
1. Study Identification
Unique Protocol Identification Number
NCT04200196
Brief Title
Improvement of Anxiety Management During a Venous Puncture About Children With a Participatory Entertainment Method
Acronym
PEDIPAIN
Official Title
Improvement of Anxiety Management During a Venous Puncture About Children 3 to 6 Years, With a Participatory Entertainment Method
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 25, 2020 (Actual)
Primary Completion Date
December 25, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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".
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
Keywords
anxiety, children
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
"Fabrique à histoire"
Arm Type
Experimental
Arm 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.
Arm Title
Usual care
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
"fabrique à histoire"
Intervention Description
"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.
Intervention Type
Procedure
Intervention Name(s)
Usual care
Intervention Description
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.
Primary Outcome Measure Information:
Title
modified Yale Preoperative Anxiety Scale (mYPAS)
Description
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
Time Frame
During venipuncture, an average of 1,5 hours
Title
modified Yale Preoperative Anxiety Scale (mYPAS)
Description
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.
Time Frame
through study completion, an average of 2 hours
Secondary Outcome Measure Information:
Title
Children face scale
Description
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)
Time Frame
through study completion, an average of 2 hours
Title
FLACC Scale
Description
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)
Time Frame
through study completion, an average of 2 hours
Title
Parent anxiety assessment
Description
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)
Time Frame
through study completion, an average of 2 hours
Title
Parent pain assessment
Description
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)
Time Frame
through study completion, an average of 2 hours
Title
Number of venous puncture before success
Description
Number of venous puncture tentative(s) before success
Time Frame
through study completion, an average of 2 hours
Title
Venous puncture success
Description
Success or not (Yes/No) of the venous puncture
Time Frame
through study completion, an average of 2 hours
Title
Time before venous puncture success
Description
Measure of time spent performing the act before its success
Time Frame
through study completion, an average of 2 hours
Title
Caregivers feedback
Description
Assessment of caregivers feedback from the gesture with an AVS 0 (worst feeling) to 10 (best feeling)
Time Frame
through study completion, an average of 2 hours
Title
Parents feedback
Description
Assessment of parents feedback from the gesture with an AVS 0 (worst feeling) to 10 (best feeling)
Time Frame
through study completion, an average of 2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Morgane CABON
Phone
02 98 22 34 88
Email
morgane.cabon@chu-brest.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Pierrick CROS
Phone
02 98 22 36 59
Email
pierrick.cros@chu-brest.fr
Facility Information:
Facility Name
CHRU de Brest
City
Brest
State/Province
Finistère
ZIP/Postal Code
29200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Morgane CABON
Phone
02 98 22 34 88
Email
morgane.cabon@chu-brest.fr
First Name & Middle Initial & Last Name & Degree
Pierrick CROS
Phone
02 98 22 36 59
Email
pierrick.cros@chu-brest.fr
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Improvement of Anxiety Management During a Venous Puncture About Children With a Participatory Entertainment Method
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