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Completed

NCT Number: NCT04117646

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

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.

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Key information

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

AP-HP, Hôpital Necker-Enfants Malades

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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

Other names: Patient questionnaire

Primary outcomes

  1. Reproducibility

    Time frame: 1 year

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

  2. Consistency reliability test

    Time frame: 1 year

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

  3. Item-total Pearson correlation

    Time frame: 1 year

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

  4. Principal components analysis

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Acronym: SN5-FR

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 7, 2019
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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