Pain Relief Satisfaction With New Educational Materials: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Pain Relief Satisfaction With New Educational Materials (NCT03698773), a randomized na study. The primary outcome is Patient Satisfaction With Pain Control in Labor.

2. Clinical Question

The trial focused on satisfaction with the pain-control choice, rather than a direct measure of pain intensity or the clinical effectiveness of a particular analgesia. Its primary question concerns participants’ reported agreement with the statement that they were satisfied with their choice for pain control in labor. The registry also identifies epidural analgesia utilization as a secondary outcome, which addresses a different aspect of care: whether participants received epidural analgesia on the day of delivery.

The comparison is between access to two information approaches, not between two analgesic treatments. Both groups had opportunities to seek information from clinical personnel, and the registry descriptions do not say that access to other sources of information was restricted. The question is therefore about the outcomes recorded under these assigned information conditions, not about the isolated effect of a website independent of the rest of care.

The registry record does not report eligibility criteria or additional details about the population beyond the trial’s labor-and-delivery context. The findings should consequently be read as results for the participants represented in this trial record, without assuming that the participants represent every laboring patient or every care setting.

3. Trial Design

The registry identifies this as a randomized, parallel-group trial with single masking. It lists the phase as not applicable and records the study as completed. The sponsor was the University of New Mexico. The recorded enrollment was 106. The study began on 2018-10-01, and primary completion was recorded on 2020-04-09.

Participants were assigned to a Baseline Group or a Website Group. The Baseline Group had access to existing educational materials about pain-relief options for labor and delivery, as well as the opportunity to ask physicians, nurses, and other relevant personnel for more information. The Website Group had access to a tablet computer displaying thepainlesspush.com, alongside the same stated opportunity to ask clinical personnel for information. The registry categorizes both interventions as other, rather than as drug or device interventions.

A parallel-group design compares the groups during the same trial period rather than assigning each participant to both information approaches in sequence. Random allocation is intended, in general, to make assigned groups comparable on average, although it cannot ensure that every characteristic is balanced in a particular trial. The record does not report the allocation procedure in further detail, such as how the random sequence was generated or concealed.

The record labels masking as single but does not identify which people were masked or describe how masking was maintained. Because the interventions involved different information access, the precise practical meaning of masking is not reported in the registry record. The registry does not report a protocol description, sample-size justification, or additional details about follow-up and adherence. These missing details limit what can be said about how the planned design was implemented beyond the recorded group descriptions and outcomes.

The primary outcome was assessed following delivery and before discharge, with the timeframe described as up to two days. The secondary outcome was epidural analgesia utilization on the day of delivery. These outcomes use different measures and have different denominators, so their reported group counts should be interpreted outcome by outcome rather than treated as one common analysis population.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Data on this outcome are available for n=97 participants total. A total of 9 participants (4 in the Baseline group and 5 in the Website group) did not provide data on the primary outcome.

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.

6. Primary Endpoint

The registry lists the primary outcome as Patient Satisfaction With Pain Control in Labor, measured over Following delivery and prior to discharge, up to two days.

The primary endpoint was participants’ satisfaction with pain control in labor, measured after delivery and before discharge. Participants responded to the statement, “I was satisfied with my choice for pain control in labor,” using a Likert scale. The recorded scale anchors were 1 for strongly disagree, 3 for neither agree nor disagree, and 5 for strongly agree. Higher scores indicate greater satisfaction. The registry describes the endpoint using the median and inter-quartile range.

This endpoint is used to capture participants’ evaluation of their own pain-control choice. Satisfaction can matter as an experience-of-care outcome even when it does not directly measure pain intensity, analgesia use, or a clinical event. In general, a self-reported satisfaction measure reflects the respondent’s judgment and can incorporate several aspects of the experience; it should not be treated as interchangeable with a measure of pain relief itself.

The median is a measure of the center of the observed scores, while the inter-quartile range describes the middle portion of their distribution. These summaries are useful for an ordinal response scale, where scores indicate ordered levels of agreement. In this trial, the group medians were both 5. The Baseline Group’s inter-quartile range was 3 to 5, and the Website Group’s was 4 to 5. The identical medians describe the central response in each group, while the differing lower quartiles describe some variation in the lower part of the recorded responses.

Primary-outcome data were available for n=97 participants total. The registry notes that 9 participants did not provide primary-outcome data: 4 in the Baseline Group and 5 in the Website Group. The reason for missing responses is not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Why compare the groups by ranks?

The primary response is recorded on an ordered Likert scale. The categories have a natural order from disagreement through neutrality to agreement, but the distances between adjacent response categories are not necessarily equal. A rank-based comparison is one way to compare the distributions of such observations without treating the scale as if every step represented an identical numerical change. The registry reports a Wilcoxon (Mann-Whitney) test for the primary comparison.

In general, the Mann-Whitney form of the Wilcoxon rank-sum test combines observations from both groups, orders them, and evaluates whether values from one group tend to rank higher or lower than values from the other. It is often described as a comparison of distributions or relative ordering. It should not automatically be interpreted as a test of median differences alone. If group distributions have different shapes or spreads, a rank-test result can reflect more than a shift in the center.

The test’s interpretation depends on the observations and assumptions, including how participants were sampled and whether observations can be treated as independent across participants. The registry record does not report further details about the implementation of the test, tie handling, or adjustments to the analysis. The displayed group medians and inter-quartile ranges give useful context, but they do not replace the distribution-level comparison.

What does a p-value convey?

In general, a p-value is calculated under a null hypothesis and a statistical model. It expresses how unusual results at least as discrepant as the observed result would be under that hypothesis and model. It does not tell the reader how large an effect is, whether an effect matters to participants, or the probability that chance alone caused the result. Interpretation also depends on the analysis plan, measurement quality, missing data, and whether many outcomes or analyses were considered.

The registry reports p=0.16 for the primary rank-based comparison. The record does not post a primary effect estimate with a confidence interval, so the precision and plausible magnitude of the group contrast cannot be read directly from an interval. A non-small p-value does not prove there is no group difference. Conversely, a small p-value would not on its own establish that a difference is important. Descriptive summaries and uncertainty measures are needed alongside a test result to assess the scale of a contrast.

How should the secondary binary outcome be analyzed?

Epidural analgesia utilization is recorded as a count of participants in each group on the day of delivery. For a binary outcome, participants fall into outcome categories such as event or no event. General comparisons can describe the event proportions, a risk difference, a relative risk, or an odds ratio. These measures answer related but different questions: the risk difference compares absolute proportions, while relative measures express one group’s event rate in relation to the other’s. A confidence interval indicates the range of values compatible with the data and the calculation’s assumptions.

The registry reports a Fisher Exact test for this secondary outcome. In general, Fisher’s exact test evaluates association in a two-by-two table using the observed margins, and can be used when counts are sparse. It yields a test result, not an effect-size estimate. A separate recalculation based on posted summary counts can produce unadjusted estimates such as a risk difference and confidence interval. Such recalculations are not adjusted for covariates and do not replace the sponsor’s reported analysis.

Confidence intervals are useful because they show estimation uncertainty as well as the point estimate. If an interval includes values on both sides of no difference, the data may be compatible with effects in either direction under the interval method. Wide intervals generally indicate limited precision. In general, binary outcomes with relatively few observations or events can produce substantial uncertainty, and a point estimate alone can obscure that uncertainty.

What does a planning illustration mean?

Planning calculations based on an observed effect are illustrations, not observed trial results and not a retrospective measure of power. A sample-size calculation asks what group size would be required under specified assumptions to detect a chosen effect with a stated probability, often called power, at a chosen significance level. The registry’s planning assumptions specify a two-sided significance level of 0.05, equal allocation, and a normal approximation; the calculation uses a fraction of the observed effect. Those assumptions describe the illustration, not necessarily the trial’s own design.

Using an observed effect as the planning target can be unstable, especially when that effect is estimated imprecisely. The estimated effect may be larger or smaller than the underlying effect, so planning for the full observed value does not guarantee that a future study would have adequate power for a clinically meaningful target. The planning rows using smaller fractions of the observed effect make clear that required group sizes depend strongly on the effect chosen. These are hypothetical design calculations, not evidence that the current trial had a particular power and not evidence of a treatment effect.

In general, over-dispersion occurs when outcome variability exceeds what a statistical model assumes. If unaccounted for, it can make standard errors too small and confidence intervals too narrow. The posted primary endpoint is ordinal and summarized by medians and inter-quartile ranges; the registry does not report an over-dispersion model for it. The concept is relevant to count or rate outcomes when their variability does not fit a simple assumed distribution, but no such model details are reported for this trial.

What cannot be established from the record?

The registry record does not report the random-sequence generation method, allocation concealment, the identities of people masked, a detailed statistical analysis plan, or a sample-size justification. It also does not report whether interim analyses were conducted, how missing primary responses were handled in the analysis, or whether analyses adjusted for baseline characteristics. These details should not be inferred from the reported test names or p-values.

Statistical methods answer defined questions under assumptions; they do not remove the need to examine outcome measurement, missing observations, and design conduct. The primary result is a rank-based comparison of reported satisfaction scores among participants with outcome data. The secondary result concerns a binary utilization measure and has its own population and analysis. Keeping these measures distinct avoids treating one statistical test as a general verdict on the entire information intervention.

10. Analyses Reported by the Sponsor

The registry’s primary analysis is a Wilcoxon (Mann-Whitney) comparison, with p=0.16. The posted primary summaries give a median of 5 in each group, with inter-quartile ranges of 3 to 5 for the Baseline Group and 4 to 5 for the Website Group. No recalculated primary contrast or confidence interval is available in the registry record, so there is no separate primary re-calculation to compare with the sponsor’s reported analysis.

The secondary outcome has a registry-reported Fisher Exact analysis and also has an unadjusted recalculation based on posted group counts. These are different presentations of the same secondary comparison: the reported test and the recalculated estimates use different statistical summaries. The recalculation is not an adjusted analysis and should not be treated as a replacement for the registry’s reported test.

The record marks no discrepancy between the posted and recalculated information. The sponsor’s reported primary analysis therefore remains the available inferential result for satisfaction. More generally, recalculations from summary data may not reproduce details of a sponsor analysis that are not fully specified in the record, such as covariate adjustment or handling of missing data. Such details are not reported in the registry record for this trial.

11. Multiplicity, Missing Data and Analysis Populations

The primary outcome was satisfaction with pain control in labor, and the registry identifies epidural analgesia utilization as a secondary outcome. The record lists two outcome measures and two analyses, but does not report a multiplicity adjustment, a testing hierarchy, or a prespecified strategy for interpreting more than one outcome. When multiple hypotheses are tested, the chance of obtaining at least one apparently unusual result can increase. In general, methods such as adjustment or a clearly defined hierarchy can manage that issue; whether any such approach was planned or used is not reported in the registry record.

Primary-outcome data were available for n=97 participants total. The record states that 9 participants did not provide data on that outcome: 4 in the Baseline Group and 5 in the Website Group. Reasons for missing responses, their timing, and the method used to handle them in the primary analysis are not reported in the registry record. It is therefore not possible to establish whether the analysis included only participants with observed responses, whether any imputation was performed, or whether a sensitivity analysis was conducted.

The primary outcome data availability differs from the group counts reported for the secondary outcome. The secondary counts are 41 of 48 in the Baseline Group and 46 of 55 in the Website Group; the record does not explain the difference in denominators between the outcomes. The data should not be assumed to represent identical analysis populations or identical rules for outcome availability.

The registry record does not report whether the primary analysis followed an intention-to-treat principle, whether participants were analyzed according to randomized assignment, or how withdrawals and protocol deviations were handled. It also does not report an analysis population definition for the secondary outcome. These omissions matter because analysis populations and missing-data methods can influence what a group comparison estimates. No specific handling approach should be inferred from the reported summaries or test results.

Random allocation is a design feature; it does not by itself resolve missing-outcome concerns after assignment. If the probability of providing an outcome differs with group assignment or with the outcome itself, the observed data may not fully represent the assigned groups. The registry record does not provide the information needed to assess that possibility. The reported results are best read as analyses of the outcome data recorded, with the missing-data and multiplicity uncertainties kept in view.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry records serious adverse events and other adverse events for participants identified as at risk in each group. It reports 0 serious adverse events and 0 other adverse events in the Baseline Group among 37 participants at risk for each category. For the Website Group, it reports 0 serious adverse events and 0 other adverse events among 43 participants at risk for each category. The recorded death count was 0 in each group.

These figures mean that no events in the listed categories were recorded in the reported at-risk groups. They do not establish that the risk of an event is zero, because an event that was not observed can still be possible. They also do not describe every aspect of safety or establish that no other symptoms or experiences occurred. The registry lists no top serious-event terms.

The at-risk counts are not the same as the enrollment count or the denominators reported for every outcome, and they should be interpreted only for the safety reporting shown. The registry record does not provide further detail about event collection, monitoring, definitions, or the period covered by the adverse-event reporting. With no reported events in these categories and no further safety detail, the record supports a narrow description of the reported counts rather than a broad conclusion about safety.

13. What the Result Does, and Does Not, Mean

The trial provides a randomized comparison of two information-access approaches and reports satisfaction scores after delivery. The observed median was 5 in each group, and the registry reports a Wilcoxon (Mann-Whitney) p-value of 0.16. These findings describe the recorded responses and the reported comparison; they do not establish that access to the website increased satisfaction or that the approaches are equivalent.

A result that does not establish a statistically clear difference is not proof of no difference. The primary analysis has no posted effect estimate or confidence interval, so the range of group contrasts compatible with the observed data cannot be assessed directly from the registry record. The sample of participants with primary outcome data and the missing responses also limit precision and interpretation. The magnitude of an effect that would matter to participants is not defined in the record.

The outcome is self-reported satisfaction with a pain-control choice. It does not directly measure pain intensity, analgesia adequacy, or whether the choice was clinically preferable. The secondary outcome, epidural analgesia utilization, describes utilization and cannot stand in for those other outcomes. Neither outcome alone captures all possible benefits, burdens, or experiences associated with educational materials.

The comparison estimates outcomes under the assigned information conditions as recorded in this trial. It does not isolate the effect of website content from access to a tablet, the opportunity to ask clinical personnel for information, participants’ prior knowledge, or other aspects of care. The registry record does not report adherence to the information approaches or details that would allow those components to be disentangled.

The results also should not be generalized automatically to settings or populations beyond those represented in the trial. Eligibility criteria, detailed participant characteristics, and other context needed to judge broader applicability are not reported in the registry record. The most defensible conclusion is bounded: the record reports similar central satisfaction scores and a nonsignificant rank-based comparison, with incomplete primary-outcome data and no posted primary confidence interval. This is not a recommendation about educational materials or pain control.

14. Why This Trial Matters Statistically

This trial illustrates why the outcome definition matters. Satisfaction with a pain-control choice is a participant-reported experience, while use of epidural analgesia is a utilization measure. They address different questions, and a statistical analysis should preserve that distinction rather than collapsing them into one broad measure of success. The record also demonstrates that an educational intervention can be studied as an access condition alongside usual opportunities to seek information, rather than as a comparison of clinical treatments.

The primary response is ordinal, making the choice of summary and test relevant. A median and inter-quartile range describe the center and spread without assuming that each step on the agreement scale is equally spaced. A rank-based test compares the ordering of observations across groups. This example underscores that the test’s target is not necessarily a simple difference between medians, even when medians are the most familiar summaries.

Missing outcomes and differing denominators are also important statistical features. The record identifies primary responses that were not obtained and reports different counts for the secondary outcome. Clear reporting of why observations are missing and how analysis populations are defined helps readers evaluate whether results represent randomized groups and whether the estimates may be affected by incomplete data.

Finally, a p-value alone is not enough to judge the magnitude or precision of a comparison. The registry gives a primary test result but no primary effect estimate with a confidence interval. This limits assessment of which effect sizes remain compatible with the data. The example is a useful reminder that statistical interpretation depends on outcome measurement, effect estimation, uncertainty, missingness, and the plan for interpreting multiple outcomes—not only on whether a p-value crosses a threshold.

15. 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.

Important design and analysis details are not reported in the registry record. These include eligibility criteria and detailed participant characteristics, the method for generating and concealing random allocation, which individuals were masked, and how masking was implemented. The record identifies a single-masked design but does not explain its practical meaning for this comparison of information access.

The primary outcome is based on one Likert-scale statement about satisfaction with a pain-control choice. The record does not report additional information about the questionnaire’s validation, how the item was administered, or whether responses were collected by people aware of group assignment. Such details can affect how readers assess the measurement and the possibility of response or assessment influences. The recorded timing is after delivery and before discharge, up to two days; longer-term satisfaction is not reported.

Primary-outcome data are missing for some participants, and the reasons and handling methods are not reported. There is no posted primary effect estimate or confidence interval, making it difficult to judge the precision and range of plausible differences. The record also does not report a sample-size justification, interim analyses, a full statistical analysis plan, or a multiplicity approach. It is not possible to determine whether the reported analyses match a prespecified plan.

The two groups both had opportunities to seek information from clinical personnel, and the record does not report use of materials, time spent with the website, participant engagement, or exposure to other information sources. Consequently, the comparison cannot separate the effect of website content from other differences in access or experience. The registry does not provide further details about the care context that might affect generalizability.

Safety reporting lists no serious or other adverse events in the stated at-risk groups, but event definitions, collection methods, and reporting period details are not provided. The absence of recorded events in these categories should therefore be interpreted narrowly. These limitations do not invalidate the reported summaries; they define the boundaries of what can be concluded from the registry record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Pain Relief Satisfaction With New Educational Materials — NCT03698773.
• Registry record last updated 2024-08-27; status last verified 2024-08.
• Results first posted 2024-06-24.
• 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.

19. Record Summary

NCT03698773 is a completed randomized, parallel-group, single-masked trial sponsored by the University of New Mexico. It compared access to routine educational materials about labor-and-delivery pain-relief options with access to a tablet displaying thepainlesspush.com; both groups could also ask clinical personnel for information. Recorded enrollment was 106.

The primary outcome was satisfaction with the participant’s pain-control choice, measured after delivery and before discharge. The median score was 5 in both groups. The registry reports a Wilcoxon (Mann-Whitney) comparison with p=0.16. Primary-outcome data were available for n=97 participants total, with 9 missing responses noted.

The sole posted secondary outcome was epidural analgesia utilization on the day of delivery. The registry reports a Fisher Exact analysis. Safety reporting records no serious or other adverse events in the stated at-risk groups and 0 deaths in each group. The registry record does not report several details needed for fuller assessment, including the primary effect estimate and confidence interval, missing-data methods, sample-size justification, and multiplicity plan.