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

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Completed
• CT.gov ID: NCT04117620
• Collaborator: (none)
• Enrollment: 85
• Location: 1
• Actual Duration (Months): 12
• Patients Per Site Per Month: 7.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Dizziness	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 Design

• Study Type: Observational
• Actual Enrollment: 85 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Validity of the French Version of the Child's Vestibular Disorder Symptoms Questionnaire
• Actual Study Start Date: Apr 28, 2020
• Actual Primary Completion Date: Apr 28, 2021
• Actual Study Completion Date: Apr 28, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Reproducibility [1 year]

   Reproducibility of the questionnaire completed by a subject at 15 days apart. Student t-test.

2. Consistency reliability test [1 year]

   Measure of efficiency. Comparison of questionnaires completed by patients and controls.

3. Item-total Pearson correlation [1 year]

   Measure of efficiency. Comparison of questionnaires completed by patients and controls.

4. Principal components analysis [1 year]

   Measure of efficiency. Comparison of questionnaires completed by patients and controls.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AP-HP, Hôpital Necker-Enfants Malades	Paris		France	75015

Sponsors and Collaborators

• Assistance Publique - Hôpitaux de Paris

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT04117620
• Other Study ID Numbers: APHP190616; ID RCB : 2019-A00364-53
• First Posted: Oct 7, 2019
• Last Update Posted: Mar 22, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Assistance Publique - Hôpitaux de Paris: Pediatric vestibular symptom; Pediatric vestibular symptom questionnaire in french
• Additional relevant MeSH terms: Vestibular Diseases; Dizziness

Study Results

No Results Posted as of Mar 22, 2022