FearTROUILLOMETRENCT02675504
Validation of a Scale of Self-assessment of Fear Faces in Children 4 to 12 Years
An observational study of Fear, run by University Hospital, Limoges at 1 site in France.
Trial summary
Since the 2000s, the experiences of children and especially their fear during a consultation, a treatment or examination is food for thought in our establishment. There is no tool validated self-assessment of fear to 6 faces. It therefore appeared necessary to us to create this tool. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Fear
- What is being tested?
- Placing a scale self-assessment of fear
- How many people
- 544 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2016to Dec 2016
- Phase
- Observational
- 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Participating in the study of children aged 4 to 12 years. In this study, participation of school children and hospitalized children
Who may be able to join
- Children aged 4 to 12 years.
- Enrolled in one of the participating institutions in the study (steps 1-5) or consultant pediatric emergencies at the Children of Limoges (step 6).
- Authorization of at least one person having parental authority for the child to participate in the study.
- Children affiliates or benefiting from a social security
Who cannot join
- Children with psychomotor disorders that prevent the use of the scale studied and understanding instructions.
- Children in vital emergency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of a Scale of Self-assessment of Fear Faces in Children 4 to 12 Years: Scary Scale
Since the 2000s, the experiences of children and especially their fear during a consultation, a treatment or examination is food for thought in our establishment. There is no tool validated self-assessment of fear to 6 faces. It therefore appeared necessary to us to create this tool. The scale self-assessment of the fear that we have developed consists of six faces representing a gradual level of fear: the child can easily describe their level of fear, which allows for appropriate care.
- Conditions
- Fear
- Being tested
- Placing a scale self-assessment of fear
- Keywords
- scary scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placing a scale self-assessment of fearOther
Children spend a self-assessment scale of fear
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of children who validate the 6 faces expressing fear.
Percentage of children who validate the 6 faces expressing fear. The test will be validated if we get a result at least 60%.
Measured: 5 minutes
Secondary outcomes (1)
Percentage of children who properly fit the faces expressing fear in ascending and descending order.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionOct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FearStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 544 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675504
- Sponsor's protocol ID
- I14006
- Acronym
- TROUILLOMETRE
- Status last verified
- Mar 2016
- First submitted
- 3 Feb 2016
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Thurillet S, Bahans C, Wood C, Bougnard S, Labrunie A, Messager V, Toniolo J, Beloni P, Fourcade L. Psychometric properties of a self-assessment fear scale in children aged 4 to 12 years. Scary Scale. J Pediatr Nurs. 2022 Jul-Aug;65:108-115. doi: 10.1016/j.pedn.2022.02.020. Epub 2022 Mar 14.
PubMed 35300885
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Scale of Self-assessment of Fear Faces in Children 4 to 12 Years: Scary Scale
- ClinicalTrials.gov ID
- NCT02675504
- Acronym / sponsor ID
- TROUILLOMETRE / I14006
- Conditions
- Fear
- Keywords
- scary scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 544 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 5 Feb 2016 (estimated)
- 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.
Since the 2000s, the experiences of children and especially their fear during a consultation, a treatment or examination is food for thought in our establishment. There is no tool validated self-assessment of fear to 6 faces. It therefore appeared necessary to us to create this tool. The scale self-assessment of the fear that we have developed consists of six faces representing a gradual level of fear: the child can easily describe their level of fear, which allows for appropriate care.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Participating in the study of children aged 4 to 12 years. In this study, participation of school children and hospitalized children
Key inclusion criteria (4 listed)
- Children aged 4 to 12 years.
- Enrolled in one of the participating institutions in the study (steps 1-5) or consultant pediatric emergencies at the Children of Limoges (step 6).
- Authorization of at least one person having parental authority for the child to participate in the study.
- Children affiliates or benefiting from a social security
Key exclusion criteria (2 listed)
- Children with psychomotor disorders that prevent the use of the scale studied and understanding instructions.
- Children in vital emergency
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 |
|---|---|---|
| Placing a scale self-assessment of fearChildren spend a self-assessment scale of fear | Other | – |
Primary outcome
Percentage of children who validate the 6 faces expressing fear.
Time frame: 5 minutes
Percentage of children who validate the 6 faces expressing fear. The test will be validated if we get a result at least 60%.
1 secondary outcome
Percentage of children who properly fit the faces expressing fear in ascending and descending order.
Time frame: 5 minutes
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 11 Jan 2019.
- Derived from this study: PubMed 35300885Thurillet S, Bahans C, Wood C, Bougnard S, Labrunie A, Messager V, Toniolo J, Beloni P, Fourcade L. Psychometric properties of a self-assessment fear scale in children aged 4 to 12 years. Scary Scale. J Pediatr Nurs. 2022 Jul-Aug;65:108-115. doi: 10.1016/j.pedn.2022.02.020. Epub 2022 Mar 14.
- Individual participant dataSharing planned: No
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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?
An observational study of Fear, run by University Hospital, Limoges 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 2 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 11 Jan 2019. 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?
Percentage of children who validate the 6 faces expressing fear. (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02675504, which also lists 1 linked publication.
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 11 Jan 2019.