Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04117646
Acronym
SN5-FR
Enrollment
89
Registered
2019-10-07
Start date
2020-04-06
Completion date
2020-06-11
Last updated
2026-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Rhinosinusitis

Keywords

Chronic rhinosinusitis of children, Sinus and nasal quality of life survey questionnaire (SN-5), Translation in French of the SN-5

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.

Interventions

Subjects respond to the translated questionnaire twice at 15 days apart.

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER
URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 12 Years
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) Controls : \- Subject without chronic rhinosinusitis at the time of inclusion and without chronic rhinitis history

Exclusion criteria

French language not spoken by parents

Design outcomes

Primary

MeasureTime frameDescription
Reproducibility1 yearReproducibility of the questionnaire completed by a subject at 15 days apart. Student t-test.
Consistency reliability test1 yearMeasure of efficiency. Comparison of questionnaires completed by patients and controls.
Item-total Pearson correlation1 yearMeasure of efficiency. Comparison of questionnaires completed by patients and controls.
Principal components analysis1 yearMeasure of efficiency. Comparison of questionnaires completed by patients and controls.

Countries

France

Contacts

PRINCIPAL_INVESTIGATORNicolas Leboulanger, MD PhD

Assistance Publique - Hôpitaux de Paris

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026