This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Effect of Squeezable Bottle Nasal Irrigation Device in Children With Sinusitis (NCT02191046), a randomized na study. The primary outcome is the Effect of Squeezable Bottle and Syringe on Clinical Effectiveness in Sinusitis Children.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02191046 |
| Phase | NA |
| Condition | Sinusitis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 80 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Thammasat University |
| Results posted | Yes |
2. Clinical Question
Population
Children with sinusitis. The registry record describes a study of nasal irrigation in this population, with symptom severity assessed using the 5S-score and satisfaction assessed using a Likert scale.
Intervention
Nasal irrigation with a squeezable bottle, using buffered hypertonic saline in an amount described as about 100-240 ml, continued until no nasal discharge.
Comparator
Nasal irrigation with a syringe identified as a 20 ml device, also using buffered hypertonic saline in an amount described as about 100-240 ml, continued until no nasal discharge.
Primary question
The study asks whether symptom scores and satisfaction differ between the irrigation-device groups. The registry describes comparing 5S-scores at baseline and 2 weeks, comparing scores between groups at 2 weeks, and comparing satisfaction between groups at 2 weeks.
The clinical question concerns a device comparison within nasal irrigation, rather than irrigation versus no irrigation. Both arm descriptions specify buffered hypertonic saline and the same stopping condition. The primary outcome description combines symptom severity and satisfaction, which are distinct kinds of measurements: the 5S-score represents reported sinusitis symptoms, while the Likert scale represents satisfaction with irrigation.
The registry record lists contamination in nasal irrigation devices as a secondary outcome. It does not provide numerical primary-outcome results, so the direction and size of any between-group difference in symptoms or satisfaction cannot be determined from the record. The clinical question can be identified, but whether the observed data favor either device is not reported in the registry record.
3. Trial Design
The registry record describes a completed randomized, parallel-group study with an enrollment of 80. The comparison was between nasal irrigation using a squeezable bottle and nasal irrigation using a 20 ml syringe. Both descriptions specify buffered hypertonic saline, about 100-240 ml, and irrigation until no nasal discharge. The record identifies Thammasat University as the sponsor.
The study was unmasked. That means participants and study personnel were not described as blinded to which device was used. Random allocation can help balance groups on average, but the registry record does not report how the random sequence was generated, whether allocation was concealed before assignment, or how adherence to the assigned device was assessed. These details are not reported in the registry record.
The primary outcome description focuses on the 5S-score and satisfaction. It refers to comparing the 5S-score at baseline with the score at 2 weeks, comparing groups at 2 weeks, and comparing satisfaction between groups at 2 weeks. The registry also lists contamination in nasal irrigation devices as a secondary outcome. The registry record does not report numerical results for the primary outcomes or the contamination outcome.
The study started in 2013-03, had primary completion in 2014-05, and is listed as completed. The registry record does not report a detailed statistical analysis plan, sample-size justification, interim analyses, or a description of the analysis population. A planning illustration based on the observed effect is described as distinct from the trial's own design; it should not be treated as evidence about the trial's achieved power.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Syringe 20 ml | Squeezable Bottle |
|---|---|---|
| STARTED | 41 | 39 |
| COMPLETED | 36 | 38 |
| NOT COMPLETED | 5 | 1 |
Reasons for not completing this period:
| Reason | Syringe 20 ml | Squeezable Bottle |
|---|---|---|
| low compliance | 5 | 1 |
Analysis population for the primary outcome, as defined in the registry: 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).
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: 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.
| Characteristic | Unit | Syringe 20 ml | Squeezable Bottle | Total |
|---|---|---|---|---|
| Participants analysed | 36 | 38 | 74 | |
| Age, Categorical: <=18 years | Participants | 36 | 38 | 74 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 0 | 0 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Female | Participants | 11 | 16 | 27 |
| Sex: Female, Male: Male | Participants | 25 | 22 | 47 |
| Region of Enrollment: Thailand | participants | 36 | 38 | 74 |
6. Primary Endpoint
The registry lists the primary outcome as the Effect of Squeezable Bottle and Syringe on Clinical Effectiveness in Sinusitis Children, measured over 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.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The main symptom measure is called the 5S-score in the registry description. It combines scores for nasal obstruction, daytime and nighttime cough, headache, and nasal discharge. Each symptom is graded from 0 for no symptom to 3 for severe symptoms, and the symptom scores are summed. The described total ranges from 0, the best possible outcome, to 15, the worst possible outcome. The measure is intended to represent overall sinusitis symptom severity rather than a single symptom.
The registry describes assessing the mean 5S-score at baseline and at 2 weeks, as well as comparing the groups at 2 weeks. A change from baseline can describe how scores shift over time within a group, while a between-group comparison addresses whether the groups differ at the follow-up assessment. These answer related but different questions, and a within-group change alone does not establish a difference between devices.
Satisfaction is described separately using a 7-point Likert scale, from 1 for unsatisfactory to 7 for excellent, with a between-group comparison at 2 weeks. Satisfaction captures participants' evaluation of irrigation, not symptom severity itself. The registry record does not report the numerical means, standard deviations, or comparative results for either measure. It also does not provide additional information on measurement validation or who completed each assessment.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the treatment comparison and the outcomes of interest, but it does not report numerical primary-outcome results. There are no posted group means, standard deviations, between-group estimates, confidence intervals, or p-values for the 5S-score or satisfaction measure in the record. Consequently, the direction, magnitude, and precision of any primary-outcome difference are not reported in the registry record. Neither benefit nor lack of benefit can be inferred from the absence of those results.
The outcome description includes both a baseline-to-2-week assessment and a comparison between groups at 2 weeks. A within-group change asks whether a group's average score changed over time. A between-group comparison asks whether outcomes differed between the assigned irrigation devices. Those questions are not interchangeable: both groups could change over time without differing from each other, or the groups could differ at follow-up even if their within-group changes are similar. The registry record does not give the numerical results needed to distinguish these patterns.
The 5S-score is a summed symptom measure with lower values representing less symptom severity, according to its stated scale. The satisfaction score has the opposite direction of interpretation: higher values represent better satisfaction. These scales should therefore be interpreted separately, and their numerical values are not directly comparable. The registry record does not state whether the statistical analysis adjusted for baseline 5S-score or how it handled the two outcome types.
The adverse-event record reports zero serious adverse events in each arm. It also reports other, non-serious adverse events for the groups: 8 among 36 at risk in the syringe group and 7 among 38 at risk in the squeezable-bottle group. These are descriptive safety counts and do not supply the missing primary-outcome results. The record does not provide further detail on event types in the listed data, nor does it report deaths.
Without outcome estimates and measures of uncertainty, the posted record does not support a quantitative assessment of how similar or different the devices were on symptoms or satisfaction. A non-significant test, if one had been reported, would not by itself establish equivalence; no such test result is reported. The interpretation is therefore limited to the study design, stated outcome definitions, and recorded adverse-event counts.
9. Statistical Methods Explained
What does the randomized parallel design mean?
In a randomized study, participants are assigned to study groups by a random process. If implemented properly, randomization can reduce systematic differences between groups at the start of the comparison, including differences that are difficult to measure. It does not guarantee that every characteristic will be balanced in a particular study. The registry identifies the study as randomized and parallel, but the sequence-generation and allocation-concealment methods are not reported in the registry record.
A parallel design means the groups receive their assigned approaches during the study rather than crossing over between the approaches as part of the described design. Here, the registry identifies the device groups as squeezable bottle and syringe. The record does not describe whether participants switched devices, so no such switching should be assumed. The study is listed as unmasked, meaning masking was not used as described in the registry. For subjective measures such as symptoms and satisfaction, knowledge of device assignment could influence reporting or assessment; the extent of any such influence cannot be determined from the registry record.
How should a mean and standard deviation be understood?
The registry identifies the primary outcome type as a continuous measure summarized by a mean and standard deviation. A mean is an average that describes the central value of a set of measurements. A standard deviation describes how dispersed individual measurements are around that average. The standard deviation is not the uncertainty around the mean: a confidence interval is a separate statistical expression of uncertainty about an estimated quantity.
For the 5S-score, a mean summarizes symptom scores across the assessed group. The scale's stated direction matters: lower scores correspond to fewer or less severe symptoms, while higher scores correspond to more severe symptoms. Satisfaction uses a separate scale whose higher values indicate better satisfaction. Means can be useful summaries, but they do not show how many participants had each individual score or whether results were concentrated or spread across the scale.
Why are baseline and follow-up comparisons different?
A baseline-to-follow-up comparison describes change over time within a group. A between-group comparison at follow-up evaluates the difference between assigned groups at that assessment. In randomized studies, the between-group contrast is generally the central comparison for the effect of assignment. A baseline-adjusted analysis may improve precision in some settings, but the registry record does not say whether such an adjustment was used. It also does not report the statistical test or model used for the outcomes.
A difference in group means is an estimate, not a complete account of the evidence. Its uncertainty is important: a confidence interval gives a range of values compatible with the data under the statistical model and reflects the precision of the estimate. A narrow interval indicates greater precision than a wide interval. The primary-outcome estimates and confidence intervals are not reported in the registry record, so precision cannot be evaluated from the posted information.
What does unmasking imply for outcome measurement?
Masking is intended to limit the influence of knowledge about assigned treatment on care, behavior, or assessment. The study is identified as having no masking. Because the devices are visibly different, masking may be difficult in this kind of comparison, but the registry record does not explain whether any outcome assessors were separately masked. Subjective symptom grading and satisfaction ratings can be susceptible to expectations or preferences. That is a general methodological concern, not evidence that such bias occurred in this trial.
Randomization and masking address different concerns. Randomization concerns how assignment is made and can support a fair group comparison. Masking concerns awareness of assignment after it is made. Having random allocation does not eliminate possible measurement or reporting effects related to unmasked treatment.
How should the planning illustration be read?
The registry describes a sample-size planning illustration based on a fraction of the observed effect, using a two-sided significance level of 0.05, equal allocation, and a normal approximation. Such calculations explore how many participants per arm might be needed under stated assumptions. They are planning illustrations, not the number observed in the completed trial, and they are never observed power. The record does not report the trial's own sample-size justification. Any calculated planning values should be interpreted as conditional on the assumed effect and method, not as evidence that the study was adequately or inadequately powered.
Planning from an observed effect also requires caution because an effect estimated in a study can be imprecise. A planning calculation cannot replace examination of the actual treatment-effect estimate and its uncertainty. Since the primary-outcome results are not reported in the registry record, the clinical results needed to understand the assumed observed effect are also unavailable in the record.
Why does over-dispersion matter in general?
For count outcomes, a statistical model may assume that the variation in the counts follows a particular relationship to their average. Over-dispersion means the observed variability is greater than that assumption allows. If ignored, standard errors can be too small and confidence intervals too narrow, making the evidence appear more precise than it is. This is a general issue for count data; the registry record does not identify an over-dispersion assessment or a count-model analysis for this study.
The adverse-event figures are presented as counts and numbers at risk. The registry does not report a comparative model or adjusted safety estimate. Descriptive counts should not be interpreted as proof of equal risk, particularly without details about event definitions, follow-up completeness, or uncertainty estimates.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome description includes several components and assessment points: 5S-score at baseline and 2 weeks, a comparison of 5S-scores between groups at 2 weeks, and satisfaction between groups at 2 weeks. Contamination in nasal irrigation devices is listed as a secondary outcome. The registry reports 2 outcome measures and 4 analyses, but does not map each analysis to a particular outcome, assessment, or contrast.
When several outcomes or comparisons are examined, the chance of obtaining at least one apparently notable result by chance can increase. Statistical methods for addressing multiplicity may include specifying a primary comparison in advance, adjusting significance thresholds, or treating additional analyses as exploratory. These are general approaches; the registry record does not report whether any multiplicity strategy was planned or used. No p-values or primary outcome estimates are reported, so the results cannot be assessed for multiplicity in practice.
Missing-data handling and analysis populations are not reported in the registry record. The record does not describe how missing symptom scores were handled, whether participants were analyzed according to randomized assignment, or whether exclusions occurred. The adverse-event figures list numbers at risk for each group, but those figures alone do not explain how the primary-outcome analysis population was defined or whether outcome data were complete.
These reporting gaps matter because estimates can depend on which participants and measurements are included, and on how missing values are handled. The record also does not report an interim-analysis plan or a detailed statistical analysis plan. Without those details and the numerical outcome results, it is not possible to evaluate the prespecification, completeness, or robustness of the reported primary analyses.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Syringe 20 ml | 0 | 36 | 0.0% |
| Squeezable Bottle | 0 | 38 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 2% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Syringe 20 ml | 8 of 36 |
| Squeezable Bottle | 7 of 38 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Syringe 20 ml | Squeezable Bottle |
|---|---|---|---|
| nasal irritation | Respiratory, thoracic and mediastinal disorders | 6 of 36 | 2 of 38 |
| nasal congestion | Respiratory, thoracic and mediastinal disorders | 1 of 36 | 4 of 38 |
| tinnitus | Ear and labyrinth disorders | 1 of 36 | 1 of 38 |
The registry lists serious adverse events for each treatment group. In the syringe group, 0 serious adverse events were reported among 36 at risk. In the squeezable-bottle group, 0 serious adverse events were reported among 38 at risk. A zero count means that no serious event was recorded in the listed group data; it does not establish that the risk is zero or that the groups have identical safety profiles.
The record also gives other adverse-event counts: 8 among 36 at risk in the syringe group and 7 among 38 at risk in the squeezable-bottle group. These are counts, not comparative estimates adjusted for follow-up or other factors. The registry does not provide event descriptions in the listed summary, confidence intervals, or a statistical comparison of these figures. Deaths are not reported as numerical counts in the adverse-event record.
Safety interpretation depends on how events were defined, collected, and followed over time. Those details are not reported in the registry record. The listed numbers should therefore be read as descriptive registry counts, separate from the unreported symptom and satisfaction outcomes. They do not establish that either device is safer.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized, unmasked comparison of squeezable-bottle and syringe nasal irrigation was conducted in children with sinusitis. It describes symptom severity, satisfaction, and contamination in irrigation devices as outcomes. It also reports serious and other adverse-event counts by group. This information helps identify what the study set out to compare and what kinds of measurements were recorded.
The record does not report the primary outcome values or the estimated differences between groups. As a result, it does not show whether the 5S-score or satisfaction was higher or lower in either group, how large any difference was, or how precise an estimate might be. An outcome result that is not reported cannot be treated as a result of no difference. Nor can the study be described as showing equivalence based on the information available in the registry record.
The stated outcome scales also have different meanings. Lower 5S-scores represent less severe symptoms, whereas higher satisfaction scores represent better satisfaction. A statistical comparison needs to respect those directions and consider each outcome on its own terms. The registry record gives the scale descriptions but not the findings needed to interpret the clinical size of a difference.
The adverse-event counts describe what is recorded for the groups, but do not provide a complete comparative safety analysis. Zero serious events in the listed data does not prove an absence of risk. The registry record does not include the event detail or uncertainty estimates needed to quantify differences in safety.
Overall, the posted information supports a description of the trial question, design, outcomes, and recorded adverse-event counts. It does not support a conclusion that one device improves symptoms, increases satisfaction, or is safer than the other. Those conclusions would require numerical outcome results and adequate information about their analysis and uncertainty.
13. Why This Trial Matters Statistically
This trial is statistically notable as a randomized comparison of two devices used for the same stated nasal-irrigation approach. Because both groups used buffered hypertonic saline and the same described stopping condition, the clinical contrast is focused on the delivery device as described in the registry. Randomization is relevant to that comparison because it can reduce systematic baseline differences between groups, although the record does not detail how assignment was implemented.
The outcome structure raises an important interpretive issue: symptom severity was described at baseline and at 2 weeks, while between-group comparisons were also described at follow-up. Within-group change and between-group difference answer distinct questions. The primary outcome description also includes satisfaction, which is not the same construct as symptom severity. Keeping these contrasts and measures separate is essential for interpreting any results.
The unmasked design is another relevant feature. For outcomes based on symptoms and satisfaction, awareness of the assigned device could influence participant reporting or assessment. This is a general concern, not a finding that bias occurred. Randomization does not remove every possible influence after allocation, so a clear description of measurement and analysis would help readers assess the results.
Most importantly, the registry record does not report numerical primary-outcome findings. That absence limits statistical interpretation more than any comparison of the posted adverse-event counts can resolve. Reporting effect estimates with uncertainty, together with the analysis population and missing-data approach, would be needed to judge the magnitude and precision of the symptom and satisfaction comparisons. The study question is clear, but the registry information is insufficient to quantify its primary results.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The primary limitation of the registry information is that numerical results for the main symptom and satisfaction outcomes are not reported in the registry record. There are no reported group means, standard deviations, treatment-effect estimates, confidence intervals, or p-values for those outcomes. This prevents assessment of the direction, size, and precision of the primary comparisons.
The study is listed as unmasked, and the principal outcomes include symptom ratings and satisfaction. Awareness of the device may influence subjective reporting in general, although the record does not establish that this occurred. The registry does not say whether outcome assessors were masked, how symptoms were elicited, or who completed the satisfaction assessment.
The record describes several primary assessments and reports 4 analyses, but does not identify how each analysis corresponds to the outcomes and time points or describe a multiplicity approach. It does not report a detailed statistical analysis plan, missing-data methods, or the analysis population. The randomization method and allocation concealment are also not reported in the registry record.
The described primary follow-up comparison is at 2 weeks. The registry information does not establish what happened beyond that assessment, so conclusions about longer-term outcomes are not supported by the stated primary timeframe. The contamination outcome is listed, but its numerical findings are not reported in the registry record.
The adverse-event summary is limited to counts and numbers at risk, without event descriptions or uncertainty estimates. The registry record also does not report the trial's own sample-size justification. These limitations restrict assessment of both the clinical findings and the precision of the study, rather than demonstrating that the devices differ or do not differ.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Effect of Squeezable Bottle Nasal Irrigation Device in Children With Sinusitis — NCT02191046.
- Registry record last updated 2014-11-04; status last verified 2014-10.
- Results first posted 2014-11-04.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT02191046 is a completed randomized, unmasked, parallel-group study sponsored by Thammasat University. It enrolled 80 children with sinusitis and compared nasal irrigation using a squeezable bottle with irrigation using a 20 ml syringe. Both arm descriptions specify buffered hypertonic saline, about 100-240 ml, until no nasal discharge. The study started in 2013-03 and had primary completion in 2014-05.
The primary outcome description covers the 5S-score, assessed at baseline and 2 weeks, and satisfaction assessed at 2 weeks. Contamination in nasal irrigation devices is listed as a secondary outcome. Numerical primary-outcome results are not reported in the registry record. Serious adverse events were recorded as 0 among 36 at risk in the syringe group and 0 among 38 at risk in the squeezable-bottle group; other adverse events were 8 and 7, respectively.
The registry describes a sample-size planning illustration based on an observed effect, but does not report the trial's own sample-size justification. Analysis methods, missing-data handling, and the mapping of analyses to outcome comparisons are not reported in the registry record.