Validation of a Scale of Self-assessment of Fear Faces in Children 4 to 12 Years (TROUILLOMETRE)

January 10, 2019 updated by: University Hospital, Limoges

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

544

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Limoges, France, 87 042
        • Limoges Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participating in the study of children aged 4 to 12 years. In this study, participation of school children and hospitalized children

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%.
5 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of children who properly fit the faces expressing fear in ascending and descending order.
Time Frame: 5 minutes
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Limoges

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

February 3, 2016

First Submitted That Met QC Criteria

February 3, 2016

First Posted (Estimate)

February 5, 2016

Study Record Updates

Last Update Posted (Actual)

January 11, 2019

Last Update Submitted That Met QC Criteria

January 10, 2019

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • I14006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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