Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 51699 for:    questionnaire

Validity of the French Version of the Child's Chronic Rhinosinusitis Questionnaire (SN5-FR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04117646
Recruitment Status : Not yet recruiting
First Posted : October 7, 2019
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment
Chronic Rhinosinusitis Other: Sinus and nasal quality of life survey questionnaire (SN-5)

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Validity of the French Version of the Child's Chronic Rhinosinusitis Questionnaire
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Group/Cohort Intervention/treatment
Patients
Patients of 2 and 12 years of age with chronic rhinosinusitis.
Other: Sinus and nasal quality of life survey questionnaire (SN-5)
Subjects respond to the translated questionnaire twice at 15 days apart.
Other Name: Patient questionnaire

Controls
Subjects of 2 and 12 years of age without chronic rhinosinusitis.
Other: Sinus and nasal quality of life survey questionnaire (SN-5)
Subjects respond to the translated questionnaire twice at 15 days apart.
Other Name: Patient questionnaire




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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 history of chronic rhinosinusitis

Exclusion Criteria:

French language not spoken by parents


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04117646


Contacts
Layout table for location contacts
Contact: Nicolas Leboulanger, MD PhD +33 1 71 39 67 85 nicolas.leboulanger@aphp.fr
Contact: Hélène Morel +33 1 71 19 63 46 helene.morel@aphp.fr

Locations
Layout table for location information
France
AP-HP, Hôpital Necker-Enfants Malades Not yet recruiting
Paris, France, 75015
Contact: Nicolas Leboulanger, MD PhD    +33 1 71 39 67 85    nicolas.leboulanger@aphp.fr   
Contact: Hélène Morel    +33 1 71 19 63 46    helene.morel@aphp.fr   
Sub-Investigator: Vincent Couloigner, MD PhD         
Sub-Investigator: Romain Luscan, MD         
Sub-Investigator: François Simon, MD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Layout table for investigator information
Principal Investigator: Nicolas Leboulanger, MD PhD Assistance Publique - Hôpitaux de Paris

Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04117646     History of Changes
Other Study ID Numbers: APHP190791
ID RCB : 2019-A00387-50 ( Other Identifier: ANSM )
First Posted: October 7, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Chronic rhinosinusitis of children
Sinus and nasal quality of life survey questionnaire (SN-5)
Translation in French of the SN-5
Additional relevant MeSH terms:
Layout table for MeSH terms
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases