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Validation of the Chinese Version of the Sinus and Nasal Quality of Life Survey (SN-5)

C

China Medical University

Status

Completed

Conditions

Chronic Rhinosinusitis

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT04836403
CMUH105-REC1-138(AR-1)

Details and patient eligibility

About

The purpose of our study was to validate the Chinese version of the Sinus and Nasal Quality of Life Survey (SN-5)and correlation with the incidence of pediatric obstructive sleep apnea and asthma.

The study will enroll pediatric patients of rhino-sinusitis and their parents to finish Questionnaire 1, including Chinese version of SN-5, visual analogue scale (VAS), Pediatric allergy disease Pediatric Allergic Disease Quality of Life Questionnaire (PADQLQ), OSA-18 quality of Life Survey, and asthma-diagnostic questionnaire . Some patients re-tested SN-5 in 1 week later. After four weeks, participants finish these questionnaire 2, including SN-5, VAS, and PADQLQ. In addition, the author will invite health children without rhino-sinusitis disease and their parents to fill in Questionnaire 1. The Chinese version of SN-5 will be validated to establish its reliability and validity.

Full description

The purpose of the study was to validate the Chinese version of the Sinus and Nasal Quality of Life Survey (SN-5)and correlation with the incidence of pediatric obstructive sleep apnea and asthma.

The study will enroll pediatric patients of rhino-sinusitis and parents to finish Questionnaire 1, including Chinese version of SN-5, visual analogue scale (VAS), Pediatric allergy disease Pediatric Allergic Disease Quality of Life Questionnaire (PADQLQ), OSA-18 quality of Life Survey, and asthma-diagnostic questionnaire . Some patients re-tested SN-5 in 1 week later. After four weeks, they finish these questionnaire 2, including SN-5, VAS, and PADQLQ. In addition, the author will invite health children without rhino-sinusitis disease and their parents to fill in Questionnaire 1. The Chinese version of SN-5 will be validated to establish its reliability and validity.

From December 2016 to December 2017, healthy volunteers and children with persistent sinonasal symptoms were enrolled. Guardians of the participants completed the SN-5, a visual analog scale (VAS) of nasal symptoms, and the Obstructive Sleep Apnea-18 (OSA-18) ; the responses were used to assess internal consistency, discriminant validity, and treatment responsiveness. A nontreatment group was administered the SN-5 1 week later to assess test-retest reliability.

Enrollment

116 patients

Sex

All

Ages

2 to 12 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Children with one or more of the following symptoms, purulent nasal discharge, nasal congestion, cough, or postnasal drip for at least 1 month.

Exclusion criteria

  • craniofacial anomalies
  • cognitive deficits
  • illiteracy in traditional Chinese.

Trial design

116 participants in 3 patient groups

Rhinosinusitis without treatment group
Description:
children aged 2 and 12 years with rhinosinusitis not receiving treatment
Treatment:
Other: Sinus and nasal quality of life survey questionnaire (SN-5)
Rhinosinusitis with treatment group
Description:
children aged 2 and 12 years with rhinosinusitis receiving treatment
Treatment:
Other: Sinus and nasal quality of life survey questionnaire (SN-5)
healthy volunteers
Description:
children aged 2 and 12 years without rhinosinusitis
Treatment:
Other: Sinus and nasal quality of life survey questionnaire (SN-5)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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