Fear Clinical Trial
— TROUILLOMETREOfficial title:
Validation of a Scale of Self-assessment of Fear Faces in Children 4 to 12 Years: Scary Scale
NCT number | NCT02675504 |
Other study ID # | I14006 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 2016 |
Est. completion date | December 2016 |
Verified date | March 2016 |
Source | University Hospital, Limoges |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 544 |
Est. completion date | December 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 12 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Children with psychomotor disorders that prevent the use of the scale studied and understanding instructions. - Children in vital emergency |
Country | Name | City | State |
---|---|---|---|
France | Limoges hospital | Limoges |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Limoges |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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%. | 5 minutes | |
Secondary | Percentage of children who properly fit the faces expressing fear in ascending and descending order. | 5 minutes |
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