NCT02675504

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
544

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2016

Completed
25 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 11, 2019

Status Verified

March 1, 2016

Enrollment Period

7 months

First QC Date

February 3, 2016

Last Update Submit

January 10, 2019

Conditions

Fear

Keywords

scary scale

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Percentage of children who properly fit the faces expressing fear in ascending and descending order.

    5 minutes

Interventions

Placing a scale self-assessment of fearOTHER

Children spend a self-assessment scale of fear

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Children with psychomotor disorders that prevent the use of the scale studied and understanding instructions.
  • Children in vital emergency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Limoges hospital

Limoges, 87 042, France

Location

Related Publications (1)

  • 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.

    PMID: 35300885DERIVED

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2016

First Posted

February 5, 2016

Study Start

March 1, 2016

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

January 11, 2019

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)