Validity of the French Version of the Child's Vestibular Disorder Symptoms Questionnaire (QEV-FR)

There is currently no score in French for evaluating disorders of the child's balance. Only one questionnaire was validated in the child in English in 2016, the " Pediatric Vestibular Symptom Questionnaire ". The objective of the research is to validate the French translation of this questionnaire.

Study Overview

• Status: Completed
• Conditions: Dizziness
• Intervention / Treatment: Other: Pediatric Vestibular Symptom Questionnaire

Detailed Description

Balance disorders are the most common cause of dizziness in children with a prevalence of 0.7 to 15%. Vestibular migraine, benign paroxysmal positional vertigo of the child, post-concussion dizziness as a result of cranial trauma, and viral vestibular neuritis are the most common causes. However, these disorders are often undiagnosed in children as many doctors may attribute these symptoms to behavioural disorders or clumsiness. This is probably because of the difficulty children may have in expressing or describing their dizziness symptoms without specific questioning, but also because of the tendency of children to accept the terminology that an adult offers them or even tend to cling to their parents when they experience a balance disorder or vertigo. Vestibular disorders can also have secondary psychological symptoms with an impact on school learning and quality of life. A precise interrogation to check the symptoms, to look for the triggers and to trace the installation of the symptoms is fundamental to diagnose and make a therapeutic decision. Thus, it is very important to help the child express his or her feelings by proposing different descriptions and formulations to determine the etiology and diagnosis. While a number of international questionnaires validated and translated into French exist in the adult to assess the presence, severity and impact of vestibular symptoms, there is currently no score in French for evaluating disorders of the child's balance. Only one questionnaire was validated in the child in English in 2016, the " Pediatric Vestibular Symptom Questionnaire ". The objective of the research is to validate the French translation of this questionnaire.

• Study Type: Observational
• Enrollment (Actual): 85

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • AP-HP, Hôpital Necker-Enfants Malades

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 17 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients followed by the department of otolaryngology and cervico-facial surgery of Necker-Enfants Malades hospital and siblings for the control subjects.

Description

Inclusion Criteria:

• Non-opposition of the holders of parental authority and the subject to participation in the study
• Subjects between 7 and 17 years of age
• Patients : patients followed in the clinic at Necker Hospital in pediatric department of otolaryngology and cervico-facial surgery and presenting with dizziness without associated ophthalmological or neurological disorder.
• Controls : subject with no vestibular deficiency, symptoms of balance disorder, migraine, otological pathology or ophthalmological disorder at the time of inclusion or background.

Exclusion Criteria:

- Absence of diagnosis after etiological assessment.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; Patients from 7 to 17 years of age with vestibular deficiency.	Other: Pediatric Vestibular Symptom Questionnaire; Subjects respond to the translated questionnaire twice with 15 days interval; Other Names: Patient questionnaire
Controls; Subjects from 7 to 17 years of age without vestibular deficiency	Other: Pediatric Vestibular Symptom Questionnaire; Subjects respond to the translated questionnaire twice with 15 days interval; Other Names: Patient questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reproducibility	Reproducibility of the questionnaire completed by a subject at 15 days apart. Student t-test.	1 year
Consistency reliability test	Measure of efficiency. Comparison of questionnaires completed by patients and controls.	1 year
Item-total Pearson correlation	Measure of efficiency. Comparison of questionnaires completed by patients and controls.	1 year
Principal components analysis	Measure of efficiency. Comparison of questionnaires completed by patients and controls.	1 year

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: François Simon, MD MSc, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• Rigal T, Parodi M, Brisse F, Denoyelle F, Loundon N, Simon F. Translation and validation of the PVSQ and DHI-PC questionnaires for pediatric dizziness. Eur Ann Otorhinolaryngol Head Neck Dis. 2023 May 22:S1879-7296(23)00072-8. doi: 10.1016/j.anorl.2023.05.001. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2020
• Primary Completion (Actual): April 28, 2021
• Study Completion (Actual): April 28, 2021

Study Registration Dates

• First Submitted: October 3, 2019
• First Submitted That Met QC Criteria: October 3, 2019
• First Posted (Actual): October 7, 2019

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 31, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Pediatric vestibular symptom; Pediatric vestibular symptom questionnaire in french
• Additional Relevant MeSH Terms: Neurologic Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Sensation Disorders; Dizziness; Vestibular Diseases
• Other Study ID Numbers: APHP190616; ID RCB : 2019-A00364-53 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No