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Clinical Trials/NCT04117646
NCT04117646CompletedNot Applicable

Validity of the French Version of the Child's Chronic Rhinosinusitis Questionnaire

Assistance Publique - Hôpitaux de Paris1 site in 1 country89 target enrollmentStarted: April 6, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
89
Locations
1
Primary Endpoint
Item-total Pearson correlation

Study Overview

Brief Summary

A single quality questionnaire evaluating the symptoms of chronic rhinosinusitis in children currently exists. It has been validated in English for children aged 2 to 12. It comprises five areas of quality of life, each rated by a score ranging from 1 to 7 : sinus infection, nasal obstruction, allergic symptoms, emotional distress and activity limitation, coupled with an overall assessment of quality of life with an analogue visual scale (score from 1 to 10). This SN-5 (sinus and nasal quality of life survey) score showed excellent statistics of reproducibility, internal validity and ease of response. It is currently used in several international publications evaluating chronic sinus pathology in children.

The objective of the study is to validate the translation of the SN-5 questionnaire in French.

Detailed Description

Chronic rhinosinusitis is a common pathology that entrains significant medical consumption. The prevalence of chronic rhinosinusitis in children is estimated to be 7.6%. Cardinal symptoms include nasal congestion, purulent rhinorrhea, facial pain, and persistent daytime cough. All these nasal symptoms often have an impact on the quality of life. The main objective of medical treatment is to improve this quality of life.

The treatment of chronic rhinosinusitis is mainly medical and includes nose washes with physiological serum, topical or general corticosteroid treatment or antibiotics. Surgical treatments such as adenoidectomy or endonasal functional surgery are reserved for medical treatment failures. According to a European consensus paper of 2012, the surgical strategy of the chronic rhinosinusitis of the child must start with a adenoidectomy with physiological serum washes, and then secondarily a endonasal functional surgery.

The ability of quality of life questionnaires to measure subjective symptoms over a certain length of time can help in the medical decision by determining the benefit of taking care. A single quality questionnaire evaluating the symptoms of chronic rhinosinusitis in children currently exists. It has been validated in English for children aged 2 to 12. It comprises five areas of quality of life, each rated by a score ranging from 1 to 7 : sinus infection, nasal obstruction, allergic symptoms, emotional distress and activity limitation, coupled with an overall assessment of quality of life with an analogue visual scale (score from 1 to 10). This SN-5 (sinus and nasal quality of life survey) score showed excellent statistics of reproducibility, internal validity and ease of response. It is currently used in several international publications evaluating chronic sinus pathology in children.

The objective of the study is to validate the translation of the SN-5 questionnaire in French.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
2 Years to 12 Years (Child)
Sex
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 2 and 12 years of age Patients : - Patients followed in consultation at Necker Hospital in pediatric department of otolaryngology and cervico-facial surgery for chronic rhinosinusitis (rhinosinusitis more than 12 weeks)
  • - Subject without chronic rhinosinusitis at the time of inclusion and without chronic rhinitis history

Exclusion Criteria

  • French language not spoken by parents

Arms & Interventions

Controls

Subjects of 2 and 12 years of age without chronic rhinosinusitis.

Intervention: Sinus and nasal quality of life survey questionnaire (SN-5) (Other)

Patients

Patients of 2 and 12 years of age with chronic rhinosinusitis.

Intervention: Sinus and nasal quality of life survey questionnaire (SN-5) (Other)

Outcomes

Primary Outcomes

Item-total Pearson correlation

Time Frame: 1 year

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

Consistency reliability test

Time Frame: 1 year

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

Reproducibility

Time Frame: 1 year

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

Principal components analysis

Time Frame: 1 year

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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