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

• Sponsor: University Hospital, Brest (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04200196
• Collaborator: (none)
• Enrollment: 136
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 30.2
• Patients Per Site Per Month: 4.5

Study Details

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".

Condition or Disease	Intervention/Treatment	Phase
Anxiety Disorders	Procedure: "fabrique à histoire"; Procedure: Usual care	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 136 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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)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)
• Primary Purpose: Other
• Official Title: Improvement of Anxiety Management During a Venous Puncture About Children 3 to 6 Years, With a Participatory Entertainment Method
• Actual Study Start Date: Jun 25, 2020
• Anticipated Primary Completion Date: Dec 25, 2022
• Anticipated Study Completion Date: Dec 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. modified Yale Preoperative Anxiety Scale (mYPAS) [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

2. modified Yale Preoperative Anxiety Scale (mYPAS) [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.

Secondary Outcome Measures

1. Children face scale [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)

2. FLACC Scale [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)

3. Parent anxiety assessment [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)

4. Parent pain assessment [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)

5. Number of venous puncture before success [through study completion, an average of 2 hours]

   Number of venous puncture tentative(s) before success

6. Venous puncture success [through study completion, an average of 2 hours]

   Success or not (Yes/No) of the venous puncture

7. Time before venous puncture success [through study completion, an average of 2 hours]

   Measure of time spent performing the act before its success

8. Caregivers feedback [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)

9. Parents feedback [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 6 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHRU de Brest	Brest	Finistère	France	29200

Sponsors and Collaborators

• University Hospital, Brest

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Brest
• ClinicalTrials.gov Identifier: NCT04200196
• Other Study ID Numbers: 29BRC19.0189
• First Posted: Dec 16, 2019
• Last Update Posted: Jan 5, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Brest: anxiety; children
• Additional relevant MeSH terms: Anxiety Disorders

Study Results

No Results Posted as of Jan 5, 2022