Anxiety DisordersPEDIPAINNCT04200196
Improvement of Anxiety Management During a Venous Puncture About Children with a Participatory Entertainment Method
A study testing "fabrique à histoire" in people with Anxiety Disorders, run by University Hospital, Brest at 1 site in France.
Trial 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". Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- "fabrique à histoire"
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jun 2020to 5 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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".
Read the 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.
- Conditions
- Anxiety Disorders
- Being tested
- "fabrique à histoire", Usual care
- Keywords
- anxiety, children
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"fabrique à histoire"Procedure or surgery
"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 careProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| "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. Receives: 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. Receives: Procedure: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: through study completion, an average of 2 hours
Secondary outcomes (9)
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)
Measured: through study completion, an average of 2 hours
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)
Measured: through study completion, an average of 2 hours
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)
Measured: through study completion, an average of 2 hours
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)
Measured: through study completion, an average of 2 hours
Number of venous puncture before success
Number of venous puncture tentative(s) before success
Measured: through study completion, an average of 2 hours
Venous puncture success
Success or not (Yes/No) of the venous puncture
Measured: through study completion, an average of 2 hours
Time before venous puncture success
Measure of time spent performing the act before its success
Measured: through study completion, an average of 2 hours
Caregivers feedback
Assessment of caregivers feedback from the gesture with an AVS 0 (worst feeling) to 10 (best feeling)
Measured: through study completion, an average of 2 hours
Parents feedback
Assessment of parents feedback from the gesture with an AVS 0 (worst feeling) to 10 (best feeling)
Measured: through study completion, an average of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start25 Jun 2020
- Primary completion5 Aug 2024
- Study completion5 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04200196
- Sponsor's protocol ID
- 29BRC19.0189
- Acronym
- PEDIPAIN
- Status last verified
- Feb 2025
- First submitted
- 11 Dec 2019
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Anxiety Management During a Venous Puncture About Children 3 to 6 Years, with a Participatory Entertainment Method
- ClinicalTrials.gov ID
- NCT04200196
- Acronym / sponsor ID
- PEDIPAIN / 29BRC19.0189
- Conditions
- Anxiety Disorders
- Keywords
- anxiety, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 25 Jun 2020 (actual)
- Primary completion
- 5 Aug 2024 (actual)
- Study completion
- 5 Aug 2024 (actual)
- First posted
- 16 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| "Fabrique à histoire" | Experimental | Procedure: "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. |
| Usual care | Active comparator | Procedure: Usual careChildren 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. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "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. | Procedure or surgery | "Fabrique à histoire" |
| Usual careIt 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. | Procedure or surgery | Usual care |
Primary outcome
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
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.
9 secondary outcomes
Children face scale
Time frame: through study completion, an average of 2 hours
FLACC Scale
Time frame: through study completion, an average of 2 hours
Parent anxiety assessment
Time frame: through study completion, an average of 2 hours
Parent pain assessment
Time frame: through study completion, an average of 2 hours
Number of venous puncture before success
Time frame: through study completion, an average of 2 hours
Venous puncture success
Time frame: through study completion, an average of 2 hours
Time before venous puncture success
Time frame: through study completion, an average of 2 hours
Caregivers feedback
Time frame: through study completion, an average of 2 hours
Parents feedback
Time frame: through study completion, an average of 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "fabrique à histoire" in people with Anxiety Disorders, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Yale Preoperative Anxiety Scale (mYPAS) (time frame: During venipuncture, an average of 1,5 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.