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

NCT04117646 | Completed

• 2 other identifiers: APHP190791ID RCB : 2019-A00387-50
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Patients

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

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

Controls

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

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

Interventions

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

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

Also known as: Patient questionnaire

Controls; Patients

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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 :

You may not qualify if:

• French language not spoken by parents

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

AP-HP, Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

Related Publications (1)

• Gargula S, Luscan R, Drummond D, Denoyelle F, Couloigner V, Leboulanger N, Simon F. French translation and validation of the Sinus and Nasal Quality of Life Survey (SN-5) in children. Int J Pediatr Otorhinolaryngol. 2021 Jun;145:110706. doi: 10.1016/j.ijporl.2021.110706. Epub 2021 Apr 6.

  PMID: 33862327 RESULT

MeSH Terms

Conditions

Fistula

Interventions

Patient Health Questionnaire

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Psychological Tests; Behavioral Disciplines and Activities; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Nicolas Leboulanger, MD PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 7, 2019
• Study Start: April 6, 2020
• Primary Completion: June 11, 2020
• Study Completion: June 11, 2020
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)