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Completed

NCT Number: NCT04200196

Improvement of Anxiety Management During a Venous Puncture About Children 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".

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Key information

Conditions

Anxiety Disorders Mental Disorders

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU de Brest

Brest, Finistère, 29200, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

"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.

usual care

Procedure

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 outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. Number of venous puncture before success

    Time frame: through study completion, an average of 2 hours

    Number of venous puncture tentative(s) before success

  6. Venous puncture success

    Time frame: through study completion, an average of 2 hours

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

  7. 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

  8. 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)

  9. 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)

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: PEDIPAIN

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Dec 16, 2019
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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