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

NCT04836403 | Completed

• 1 other identifier: CMUH105-REC1-138(AR-1)
• Study Type: observational
• Target: 116
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Rhinosinusitis

Keywords

SN-5; Quality of life; children

Outcome Measures

Primary Outcomes (3)

• Test-retest reliability

  A nontreatment group was administered the SN-5 1 week later to assess test-retest reliability.

  1 week

• Concurrent validity

  The correlation between SN-5 and VAS scores was used to analyze the concurrent validity of the SN-5.

  baseline

• 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 Outcomes (2)

• the mean scores of SN-5

  4 week

• correlation with score of SN-5 and score of OSA-18 quality of life questionnaire (OSA-18)

  baseline and 4 week

Study Arms (3)

Rhinosinusitis without treatment group

children aged 2 and 12 years with rhinosinusitis not receiving treatment

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

Rhinosinusitis with treatment group

children aged 2 and 12 years with rhinosinusitis receiving treatment

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

healthy volunteers

children aged 2 and 12 years without rhinosinusitis

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

Interventions

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

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)

Rhinosinusitis with treatment group; Rhinosinusitis without treatment group; healthy volunteers

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Rhinosinusitis patients were recruited from pediatric clinics practicing Western or Chinese medicine

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• China Medical University Hospital: lead

Related Publications (1)

• Lai WY, Kay DJ, Wei CC, Huang FW, Liang KL, Yen HR. Validation of the traditional Chinese version of the Sinus and Nasal Quality of Life Survey (SN-5) for children. Pediatr Neonatol. 2022 Jul;63(4):410-417. doi: 10.1016/j.pedneo.2022.01.008. Epub 2022 May 2.

  PMID: 35595617 DERIVED

Study Design

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

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 8, 2021
• Study Start: December 1, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: August 5, 2021

Record last verified: 2021-08