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Effect of Squeezable Bottle Nasal Irrigation Device in Children With Sinusitis

Primary Purpose

Sinusitis

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
squeezable bottle
syringe 20 ml
Sponsored by
Thammasat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sinusitis focused on measuring nasal irrigation, sinusitis, children, buffered hypertonic saline, nasal irrigation device

Eligibility Criteria

3 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. age 3-15 years
  2. diagnose sinusitis by each of following criteria 2.1 persistent upper respiratory infection symptoms > or = 10 days 2.2. severe upper respiratory infection symptom with greenish discharge per nose or periorbital swelling 2.3 double sickening of upper respiratory infection symptoms

Exclusion Criteria:

  1. patient who has history of penicillin allergy
  2. patient who has complication of sinusitis
  3. patient with a history of nasal anatomical defects
  4. patient who has immune deficiency or primary ciliary dyskinesia

Sites / Locations

  • Araya Satdhabudha

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

syringe 20 ml

squeezable bottle

Arm Description

nasal irrigation with syringe by using buffer hypertonic saline about 100-240 ml until no nasal discharge

nasal irrigation with squeezable bottle by using buffer hypertonic saline about 100-240 ml until no nasal discharge

Outcomes

Primary Outcome Measures

the Effect of Squeezable Bottle and Syringe on Clinical Effectiveness in Sinusitis Children
For 5S-score, we measured the the mean 5-s score of both group at 2 weeks compare to the mean 5-s score at baseline visit and compare 5S-score between group at 2 weeks. The S5- score is a scale assessing severity of sinusitis. It compose of the symptom scores for nasal obstruction, day and nighttime cough, headache and nasal discharge. All symptom were graded from 0(no symptom) to 3 (severe ).The score were summed to give the mean 5S-score.It range from 0 (best possible outcome) to 15(worst possible outcome). 7-point Likert scale for satisfaction score is scale from 1 (indicating unsatisfactory) to 7 (indicating excellent). For satisfaction, we reported the result in the term of 7 points Likert scale and compare these scale between group at 2 weeks after treatment

Secondary Outcome Measures

the Contamination in Nasal Irrigation Devices
compare the result of bacterial culture in both group of nasal irrigation devices. We reported in the following item; no growth, gram positive or gram negative or mixed organism

Full Information

First Posted
July 13, 2014
Last Updated
October 31, 2014
Sponsor
Thammasat University
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1. Study Identification

Unique Protocol Identification Number
NCT02191046
Brief Title
Effect of Squeezable Bottle Nasal Irrigation Device in Children With Sinusitis
Official Title
A Randomized- Controlled Study Comparing the Effect of Squeezable Bottle Nasal Irrigation Device With Syringe in Children With Sinusitis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thammasat University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to the effect of squeezable bottle nasal irrigation device with syringe in children with sinusitis in symptom score and satisfaction to nasal irrigation
Detailed Description
sinusitis is the one of common diseases in Thailand. Nasal irrigation has been used as an adjunctive treatment.In previous study shown that buffer hypertonic nasal irrigation have more effective to decrease symptom in patient sinonasal disease when compare to normal saline.Until now, there are no clear data comparing the effectiveness on sinonasal symptom of the various devices use in children with sinusitis. The purpose of this study was to compare the effect of squeezable bottle nasal irrigation device with syringe in children with sinusitis in symptom score and satisfaction to nasal irrigation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinusitis
Keywords
nasal irrigation, sinusitis, children, buffered hypertonic saline, nasal irrigation device

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
syringe 20 ml
Arm Type
Active Comparator
Arm Description
nasal irrigation with syringe by using buffer hypertonic saline about 100-240 ml until no nasal discharge
Arm Title
squeezable bottle
Arm Type
Experimental
Arm Description
nasal irrigation with squeezable bottle by using buffer hypertonic saline about 100-240 ml until no nasal discharge
Intervention Type
Device
Intervention Name(s)
squeezable bottle
Other Intervention Name(s)
EEZNIS
Intervention Description
nasal irrigation twice daily for 2 weeks period
Intervention Type
Device
Intervention Name(s)
syringe 20 ml
Intervention Description
nasal irrigation twice daily for 2 weeks
Primary Outcome Measure Information:
Title
the Effect of Squeezable Bottle and Syringe on Clinical Effectiveness in Sinusitis Children
Description
For 5S-score, we measured the the mean 5-s score of both group at 2 weeks compare to the mean 5-s score at baseline visit and compare 5S-score between group at 2 weeks. The S5- score is a scale assessing severity of sinusitis. It compose of the symptom scores for nasal obstruction, day and nighttime cough, headache and nasal discharge. All symptom were graded from 0(no symptom) to 3 (severe ).The score were summed to give the mean 5S-score.It range from 0 (best possible outcome) to 15(worst possible outcome). 7-point Likert scale for satisfaction score is scale from 1 (indicating unsatisfactory) to 7 (indicating excellent). For satisfaction, we reported the result in the term of 7 points Likert scale and compare these scale between group at 2 weeks after treatment
Time Frame
compare 5S-score of both group at 2 week and at baseline visit .compare the mean 5S-score and satisfaction score between both group at 2 weeks after treatment
Secondary Outcome Measure Information:
Title
the Contamination in Nasal Irrigation Devices
Description
compare the result of bacterial culture in both group of nasal irrigation devices. We reported in the following item; no growth, gram positive or gram negative or mixed organism
Time Frame
at second week after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age 3-15 years diagnose sinusitis by each of following criteria 2.1 persistent upper respiratory infection symptoms > or = 10 days 2.2. severe upper respiratory infection symptom with greenish discharge per nose or periorbital swelling 2.3 double sickening of upper respiratory infection symptoms Exclusion Criteria: patient who has history of penicillin allergy patient who has complication of sinusitis patient with a history of nasal anatomical defects patient who has immune deficiency or primary ciliary dyskinesia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Araya Satdhabudha, MD
Organizational Affiliation
Thammasat University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Araya Satdhabudha
City
Klongluang
State/Province
Pratumthanee
Country
Thailand

12. IPD Sharing Statement

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Effect of Squeezable Bottle Nasal Irrigation Device in Children With Sinusitis

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