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

Chronic Rhinosinusitis Clinical Trial

Official title:

Validation of the Chinese Version of the Sinus and Nasal Quality of Life Survey (SN-5) and Correlation With Pediatric Obstructive Sleep Apnea and Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04836403
• Other study ID #: CMUH105-REC1-138(AR-1)
• Status: Completed
• Start date: December 1, 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: August 2021
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Rhinosinusitis

Intervention

Other:
• Sinus and nasal quality of life survey questionnaire (SN-5)
The SN-5 consists of five questions on a 7-point scale that assesses the frequency of the following symptoms: (1) nasal obstruction, (2) sinus infection, (3) allergies, (4) emotional distress, and (5) activity limitations. The scoring system is as follows: 1 indicates "none of the time," 2 indicating "hardly any time at all," 3 indicates "a small part of the time," 4 indicates "some of the time," 5 indicates "a good part of the time," 6 indicates "most of the time," and 7 indicates "all of the time." Higher scores indicate more severe sinonasal symptoms. One item from a global faces scale scored from 0 to 10 is used to evaluate overall QoL related to nasal or sinus disease. Higher scores on this scale indicate a less severe impact of nasal or sinus disease. The scores from the first five items (1-7 each)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Test-retest reliability	A nontreatment group was administered the SN-5 1 week later to assess test-retest reliability.	1 week
Primary	Concurrent validity	The correlation between SN-5 and VAS scores was used to analyze the concurrent validity of the SN-5.	baseline
Primary	Discriminant validity	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.	baseline
Secondary	the mean scores of SN-5	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.	4 week
Secondary	correlation with score of SN-5 and score of OSA-18 quality of life questionnaire (OSA-18)	To evaluate the correlation of SN-5 and OSA-18, Spearman correlation coefficients between the SN-5 and OSA-18 scores were analyzed.	baseline and 4 week