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| ID | Type | Description | Link |
|---|---|---|---|
| 45/2555 | Other Grant/Funding Number | Thammasat research grant |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| syringe 20 ml | Active Comparator | nasal irrigation with syringe by using buffer hypertonic saline about 100-240 ml until no nasal discharge |
|
| squeezable bottle | Experimental | nasal irrigation with squeezable bottle by using buffer hypertonic saline about 100-240 ml until no nasal discharge |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| squeezable bottle | Device | nasal irrigation twice daily for 2 weeks period |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at second week after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Araya Satdhabudha, MD | Thammasat University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Araya Satdhabudha | Klongluang | Pratumthanee | Thailand |
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we enrolled sinusitis patient age 3-15 year during March 2013 - May 2014. We excluded patients with a history of penicillin allergy, nasal anatomic defects, immunodeficiency or had complication from sinusitis. Patient with low compliance defined as the rate usage nasal irrigation estimated at less than 80% were excluded
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| ID | Title | Description |
|---|---|---|
| FG000 | Syringe 20 ml | nasal irrigation with syringe by using buffer hypertonic saline about 100-240 ml until no nasal discharge syringe 20 ml: nasal irrigation twice daily for 2 weeks period |
| FG001 | Squeezable Bottle | nasal irrigation with squeezable bottle by using buffer hypertonic saline about 100-240 ml until no nasal discharge squeezable bottle: nasal irrigation twice daily for 2 weeks period |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Eighty sinusitis children participated in the study. 74 participants were finally assessed. six participants were discontinue irrigated their nose during treatment due to the nasal symptoms score improve; one patient from squeezable bottle group, five patients from disposable syringe group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Syringe 20 ml | nasal irrigation with syringe by using buffer hypertonic saline about 100-240 ml until no nasal discharge syringe 20 ml: nasal irrigation twice daily for 2 weeks period |
| BG001 | Squeezable Bottle |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | The S5- score is 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.7-point Likert scale for satisfaction score is scale from 1 (indicating unsatisfactory) to 7 (indicating excellent). | Posted | Mean | Standard Deviation | units on a scale | 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 |
we monitor side effect from the beginning of treatment until 2 weeks after treatment
we monitor side effect from the beginning of treatment until 2 weeks after treatment. the physician asking the symptoms after nasal irrigation at baseline visit then the symptoms were recorded daily by parents and noted in diary card
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Syringe 20 ml | record adverse event at baseline and daily adverse events until 2 weeks after treatment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nasal irritation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Araya Satdhabudha | Thammasat university | 0813414900 | 662 | araya221@gmail.com |
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| ID | Term |
|---|---|
| D012852 | Sinusitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
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| ID | Term |
|---|---|
| D013594 | Syringes |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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| syringe 20 ml | Device | nasal irrigation twice daily for 2 weeks |
|
nasal irrigation with squeezable bottle by using buffer hypertonic saline about 100-240 ml until no nasal discharge
squeezable bottle: nasal irrigation twice daily for 2 weeks period
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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|
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| Secondary | 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 | Not Posted | at second week after treatment |
| 0 |
| 36 |
| 8 |
| 36 |
| EG001 | Squeezable Bottle | record adverse event at baseline and daily adverse events until 2 weeks after treatment | 0 | 38 | 7 | 38 |
| nasal congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| tinnitus | Ear and labyrinth disorders | Non-systematic Assessment |
|
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| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |