Validation of the Chinese Version of the Sinus and Nasal Quality of Life Survey (SN-5)
- Conditions
- Chronic Rhinosinusitis
- Interventions
- Other: Sinus and nasal quality of life survey questionnaire (SN-5)
- Registration Number
- NCT04836403
- Lead Sponsor
- China Medical University Hospital
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 116
Children with one or more of the following symptoms, purulent nasal discharge, nasal congestion, cough, or postnasal drip for at least 1 month.
- craniofacial anomalies
- cognitive deficits
- illiteracy in traditional Chinese.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description healthy volunteers Sinus and nasal quality of life survey questionnaire (SN-5) children aged 2 and 12 years without rhinosinusitis Rhinosinusitis with treatment group Sinus and nasal quality of life survey questionnaire (SN-5) children aged 2 and 12 years with rhinosinusitis receiving treatment Rhinosinusitis without treatment group Sinus and nasal quality of life survey questionnaire (SN-5) children aged 2 and 12 years with rhinosinusitis not receiving treatment
- Primary Outcome Measures
Name Time Method Test-retest reliability 1 week A nontreatment group was administered the SN-5 1 week later to assess test-retest reliability.
Concurrent validity baseline The correlation between SN-5 and VAS scores was used to analyze the concurrent validity of the SN-5.
Discriminant validity baseline Discriminant validity was assessed by calculating the difference between the SN-5 scores for participants with rhinosinusitis and for the healthy participants. These differences were analyzed with the Mann-Whitney U test.
- Secondary Outcome Measures
Name Time Method the mean scores of SN-5 4 week To evaluate the responsiveness of the treatment , the author compare the mean score of treatment group after 4-week-treatment compared to baseline mean score of SN-5 before treatment.Data analyzed with the Wilcoxon signed-rank test. Effects were evaluated through intention-to-treat analysis.
correlation with score of SN-5 and score of OSA-18 quality of life questionnaire (OSA-18) baseline and 4 week To evaluate the correlation of SN-5 and OSA-18, Spearman correlation coefficients between the SN-5 and OSA-18 scores were analyzed.